US market access requirements

3.2 US market access requirements

Because there are extensive market access resources readily available from governmental and/or international governmental organizations such as the International Trade Centre (ITC) of the United Nations Conference on Trade and Development (UNCTAD) and the United States Department of Commerce International Trade Center, among others, only a brief overview of market access requirements will be provided in this market study.

 

3.2.1 Legislative requirements (US)

Legislative requirements are to a certain extent dependent on the end-use of the natural ingredients. Different regulations and requirements are in place for ingredients used in cosmetics, dietary supplements, foods, and pharmaceuticals. It is conceivable that a single natural ingredient could be utilized in all four of these product categories, therefore an awareness of legislative requirements for each is useful for the exporter.

Registration of Foreign Facilities under the Bioterrorism Act

The US Congress responded to the events of 11 September 2001 by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which President Bush signed into law 12 June 2002.

On 19 March 2003, the US FDA released guidance documents addressing food and cosmetic security preventive measures, including the registration of foreign suppliers of ingredients with the FDA. The FDA designed these guidance documents as a way to help US product manufacturers minimize the risk of tampering or other malicious, criminal or terrorist actions. In the US, natural ingredients, including medicinal herbs and extracts, and/or oral use natural products made from natural ingredients are, for the most part, regulated as “dietary supplements,” a sub-set of food regulations rather than drug regulations, and external use natural products are regulated as non-drug cosmetics or cosmetic drugs. Therefore, natural ingredients used in both cosmetics and/or dietary supplements are covered by the Bioterrorism Act and these new FDA guidelines.

The rule also requires importers to provide “prior notice” of imports to FDA and the Bureau of Customs and Border Protection that includes:

  • Identification of the submitter, including name and firm
  • Entry type and US Customs System (ACS) entry number, or other US Customs identification number for the import
  • Identification of the articles, including complete FDA product code, the common or usual name or market name, the quantities, and the lot or code numbers
  • Identification of the manufacturer
  • Identification of the grower
  • Country of origin
  • Identification of the shipper
  • Anticipated date, time and location of arrival
  • US Customs entry process information
  • Identification of the importer, owner, and consignee
  • Identification of the carrier
Three relevant “Guidance for Industry” documents, concerning importers and exporters of natural ingredients, are available from the FDA to down at the following Internet addresses:

1. Importers and Filers: Food Security Preventive Measures Guidance. Available to download at:http://www.cfsan.fda.gov/~dms/secguid7.html

2. Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance. Available to download at: http://www.cfsan.fda.gov/~dms/secguid4.html

3. Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance. Available to download at: http://www.cfsan.fda.gov/~dms/secguid6.html

Additionally, other relevant information concerning the Agricultural Bioterrorism Protection Act of 2002 can be obtained at the Agricultural Bioterrorism web-page of the Animal and Plant Health Inspection Service (APHIS) of the USDA: http://www.aphis.usda.gov/programs/ag_selectagent.

APHIS also has a “Trade Support Team” which functions as the central office for tracking pending trade issues and initiatives, as well as working to ensure that APHIS' concern for protecting US agriculture's biosecurity is considered by other US government agencies as they develop and implement broader trade policies.


Good Manufacturing Practices (GMPs)

Cosmetic GMPs: There are no regulations setting forth specific GMP requirements for non-drug cosmetics. In contrast, the law requires strict adherence to GMP requirements for cosmetics that are classified as drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a cosmetic drug to be adulterated under the FD&C Act, sec. 501(a)(2)(B). Title 21 of the CFR can be viewed at: http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200221. FDA’s Cosmetic GMP Guidelines can be viewed at: http://www.cfsan.fda.gov/~dms/cos-gmp.html.

Dietary Supplement GMPs: The “Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements” are available online at: http://www.cfsan.fda.gov/~lrd/fr07625a.html.[1]

The regulation establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Foreign firms that export finished dietary supplement products to the United States must satisfy the requirements of this regulation. FDA does not have data on the number of foreign firms that export dietary supplements to the United States. The small number of foreign products in the FDA dietary supplement sales database suggests that relatively few foreign firms export dietary supplements to the United States. The foreign firms that will be most affected by this regulation are suppliers of natural ingredients for use in dietary supplement products. Although suppliers of dietary ingredients are not directly covered by the regulation, the need of manufacturers to meet the ingredient specifications required by the regulation will indirectly affect foreign suppliers (as well as domestic suppliers).

Of relevance for the approval and qualification of foreign suppliers of natural ingredients that will be used in U.S. dietary supplement products, these CGMPs include requirements for the finished product manufacturer to establish ingredient specifications as follows:

  1. You must establish an identity specification;
  2. You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and
  3. You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

The Quality Control (QC) Unit of the finished product manufacturer must determine whether specifications are met as follows:

(a) Before you use a component, you must:

(1) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient; and

(2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with Sec.  111.70(b) are met. To do so, you must either

(i) Conduct appropriate tests or examinations; or

(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that:

(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations;

(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;

(C) You maintain documentation of how you qualified the supplier;

(D) You periodically re-confirm the supplier's certificate of analysis; and

(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.

The finished product manufacturer must ensure that the tests and examinations that are used to determine whether the specifications are met are appropriate, scientifically valid methods. The tests and examinations that are used must include at least one of the following:

  1. Gross organoleptic analysis;
  2. Macroscopic analysis;
  3. Microscopic analysis;
  4. Chemical analysis; or
  5. Other scientifically valid methods.
  6. You must establish corrective action plans for use when an established specification is not met.

Pharmaceutical GMPs: Regulations affecting the specifications, testing and release of components, including natural ingredients for use in pharmaceutical products are laid out in the “Current Good Manufacturing Practice for Finished Pharmaceuticals,”  which are found in the Code of Federal Regulations, Title 21, Chapter 1, Section §211.84: “Testing and approval or rejection of components, drug product containers, and closures,” which is excerpted here below and the entire CGMP regulations are  available to download on-line at: http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr211_07.html.

 

TITLE 21: FOOD AND DRUGS

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

PART 211:CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart E: Control of Components and Drug Product Containers and Closures

Sec. 211.84: Testing and approval or rejection of components, drug product containers, and closures.

(a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.

(b) Representative samples of each shipment of each lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by Sec. 211.170.

(c) Samples shall be collected in accordance with the following procedures:

(1) The containers of components selected shall be cleaned where necessary, by appropriate means.

(2) The containers shall be opened, sampled, and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures.

(3) Sterile equipment and aseptic sampling techniques shall be used when necessary.

(4) If it is necessary to sample a component from the top, middle, and bottom of its container, such sample subdivisions shall not be composited for testing.

(5) Sample containers shall be identified so that the following information can be determined: name of the material sampled, the lot number, the container from which the sample was taken, the date on which the sample was taken, and the name of the person who collected the sample.

(6) Containers from which samples have been taken shall be marked to show that samples have been removed from them.

(d) Samples shall be examined and tested as follows:

(1) At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used.

(2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

(3) Containers and closures shall be tested for conformance with all appropriate written procedures. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals.

(4) When appropriate, components shall be microscopically examined.

(5) Each lot of a component, drug product container, or closure that is liable to contamination with filth, insect infestation, or other extraneous adulterant shall be examined against established specifications for such contamination.

(6) Each lot of a component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use.

(e) Any lot of components, drug product containers, or closures that meets the appropriate written specifications of identity, strength, quality, and purity and related tests under paragraph (d) of this section may be approved and released for use. Any lot of such material that does not meet such specifications shall be rejected.

 

3.2.1 Non-legislative requirements (US)

Social, environmental and quality related market requirements are of growing importance in international trade and are increasingly being requested by American buyers through labels, codes of conduct and management systems.

3.2.2.1 Environmental market access requirements (US)

American buyers are increasingly demanding evidence of sustainability (ecological, economical, and social sustainability) throughout the supply chain. In addition to (pioneer) natural marketplace companies whose founders and decision-makers have always believed in and have supported the sustainable agriculture and sustainable wild collection movements, respectively, increasing numbers of companies are now publishing annual corporate sustainability reports as well as corporate social responsibility reports. Such companies are looking for supply partners who can help them to achieve their mission and to improve their sustainability ratings.

Organic certification is of course non-mandated and therefore it is a voluntary activity for the producer. However when exporting natural ingredients that are labeled as certified organic to trade partners in the USA, compliance with legislative requirements under the organic regulations then become relevant for market access. For natural ingredients produced under controlled cultivation, certification according to the USDA National Organic Program (NOP) should be taken into consideration for adding value to the crops and addressing the trend of increasing demand for certified organic ingredients and natural products. The USDA NOP regulations are available online at: http://www.ams.usda.gov/nop/NOP/NOPhome.html.

Concerning the use of endangered species, the following policy is excerpted from the “American Herbal Products Association (AHPA) Code of Ethics & Business Conduct.”[3]

 

Endangered Species

Endangered species of plants should not be traded by AHPA members. Members who wish to use such species in their products should obtain them from verifiable, commercially cultivated sources. Members should encourage selective harvesting and stewardship of wild stands of plants to maintain viable local plant populations. The term “endangered species” is consistent with the definitions of endangered species as established by the U.S. Endangered Species Act or as established by CITES Appendix I.

AHPA members who use plants listed in CITES Appendix II are encouraged to do so in a manner consistent with the spirit and letter of CITES Appendix II.

For wild collected natural ingredients, in order to address the growing trend for sustainably produced ingredients, a determination of the maximum optimal sustainable yield from wild collection of Malaysian botanical raw materials should be taken into consideration in order to ensure long-term sustainable trade to the global market. This should also be independently verified and certified for credibility in the marketplace. It has been reported that the local Malaysian herbal industry obtains about 50% of its required botanical raw materials from collection in the forests,[4] and the mission of the Forestry Department is to sustainably manage and develop the forest resources and optimize their contributions to national socio-economic development.[5]

It is recommended that wild collection of Malaysian raw materials, that are destined for the U.S. market (whether in the form of crude raw materials or in valued-added extracted or processed forms), should, at a minimum, be collected under the supervision of organic certification of wild crops. Above and beyond organic certification, the highest standard would be to independently verify that the raw materials were collected in conformance with the International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP).[6] Another very useful guideline for both cultivation and wild collection of herbs is the draft “American Herbal Products Association (AHPA) / American Herbal Pharmacopoeia (AHP) Good Agricultural and Collection Practice (GACP) for Herbal Raw Materials.”[7] The following explanatory text is excerpted from the Introduction of the AHPA/AHP GACP:

This draft AHPA-AHP Good Agricultural and Collection Practice (GACP) document provides guidance to growers and collectors of herbs that are used in consumer products. Its goals are to ensure that the herbal raw materials used in these products are accurately identified and are not adulterated with contaminants that may present a public health risk, and are in full conformity with all of the quality characteristics for which they are represented. In many countries, standards of identity, quality, and purity for herbal ingredients used in medicines are codified in national pharmacopeias and are mandatory standards. In the United States, standards are established by buyers, either to their own specifications or to those set by an authoritative body, such as the American Herbal Pharmacopoeia or the United States Pharmacopeia.

The AHPA-AHP GACP has relevance to herbal raw materials in all herbal products, including foods, dietary supplements, drugs, cosmetics, etc. This GACP is intended to have applications to all herbal raw material production, whether the herbs are cultivated by conventional or organic methods or harvested from the wild. While this document may be useful in any country, it is limited to rules in the United States when it addresses regulatory issues. This guidance serves as a template that growers and harvesters can adapt to their own businesses and is designed to have relevance for both small and large producers. By establishing standard operating procedures that follow the practices presented here, firms at every level in the supply chain will better ensure the production of good quality herbal raw materials.

A certification scheme to consider for wild collected natural ingredients, known as “FairWild,” is available through the Swiss Import Promotion Organization (SIPPO) and certification is managed through the Institute for Marketecology (IMO).[8] FairWild Certified Malaysian natural ingredients may be a potentially strong opportunity for increasing market share while also earning a price premium over non-certified wild collected raw materials. FairWild is certifiable and provides the buyers with transparency and the assurance that products are produced in a socially and ecologically sound way. Traceability and better product safety add additional marketing arguments for the final consumer. FairWild is developed as an additional module to the ecologically focused management criteria defined in the aforementioned ISSC-MAP. This standard defines guidelines and provides tools to the collectors and producers for the planning and implementation of a sustainable resource management system – a guarantee for constant and reliable supply of raw materials for industry and traders. Organic certification of the wild collection practices is also accepted as minimum demonstration of ecologically sound production practices.


3.2.2.2 Social and Religious market access requirements (US)


Fair Trade

Although coffee beans are not within the scope of this market study, to illustrate a useful example Fair Trade Certified™ coffee is now the fastest-growing segment of the US specialty coffee market. TransFair USA began certifying Fair Trade coffee in 1999. Since then, TransFair has certified 33.7 million kg of Fair Trade coffee. This has provided coffee farmers in some of the poorest communities in Latin America, Africa, and Asia with over USD $60 million more than they would have earned selling their harvests to local intermediaries. This means that each dollar of TransFair USA's budgets has been translated into more than $7 in supplemental income for farmers and farm workers since 1999. Fair Trade in the USA is no longer just about coffee. Fair Trade Certification is now available in the U.S. for coffee, tea (including tea leaf and rooibos herb) and herbs (including chamomile flower, hibiscus flower, peppermint leaf, spearmint leaf), cocoa products (including cocoa butter) and chocolate, fresh fruits (including tropical fruits), sugar, rice, and vanilla beans.[9]

Table 3.2 shows US imports of Fair Trade Certified™ teas, 2001-2006, including an estimation of the percentage that is also Certified Organic.

Table 3.2:         U.S. Imports of Fair Trade Certified™ Tea, + Organic Fair Trade, 2001-2006

Year

Fair Trade Certified Volume (kg)

Volume Growth (kg)

Growth Rate

Volume also Certified Organic (kg)

Organic

Volume

Growth (kg)

Organic Growth Rate

Organic as % of Total Fair Trade Certifie

<2001

29,602

19,169

n/a

n/a

0%

0%

2002

39,329

9,727

33%

n/a

n/a

0%

0%

2003

43,395

4,65

10%

38,188

n/a

0%

88%

2004

81,788

38,393

88%

81,712

43,524

114%

100%

2005

234,736

152,948

187%

205,306

123,594

151%

87%

2006

285,759

51,023

22%

269,692

64,386

31%

94%

 

 

 

 

 

 

 

 

TOTAL

714,609

 

 

594,898

 

 

92%

* Volume of Certified Organic Tea is not available prior to 2003

* Organic as a percentage of total (92%) represents the years for which data is available, 2003-present.

* Because premiums in tea are not tied to organic status, organic numbers should only be taken as an estimate.

 

SOURCE: TransFair USA. Fair Trade Almanac 1998-2006. Oakland, CA: TransFair USA. 2007.

According to the International Fair Trade Association’s “IFAT Annual Report 2006,” 2006 was another important year for Fair Trade. Global sales figures of Fair Trade products in 2006 are estimated to be in excess of USD $2.6 billion and Fair Trade (average of all product categories) continues to grow at rates of 20 to 30 per cent a year. The IFAT Report states that the Asian Fair Trade Forum (AFTF), in an effort to increase market access to the United States, is conducting a U.S. Market Study. The AFTF has engaged the services of ex­perts to conduct the US Market Study which aims to define the supply chain structure (including main­stream buyers) and current size of US market for products of the types produced by AFTF members. It also sought to establish the market strategy for AFTF including the feasibility of setting up an Importing & Representative Agency representing AFTF members in North America. Phase 1, which was completed as of September 2006, employed multiple method­ologies to assess the potential for AFTF members to gain access in the USA, both traditional Fair Trade distribution channels as well as the new and large mainstream opportunities. Results of Phase 1 were presented at the Asia Regional Conference on 18 Sep­tember 2006. Phase 2 will involve the development of a practi­cal and rapid action plan to jumpstart a trading and representation business in the USA market, concen­trating on developing new relations with mainstream buyers, as well as uncovering new Fair Trade chan­nels of distribution. This phase is now ongoing.[10]

 

Religious certifications: Halal and Kosher

Religious certification of ingredients used in cosmetics, dietary supplements, foods, and pharmaceuticals is becoming increasingly important in the North American natural marketplace. Companies are increasingly positioning their products towards the sensibilities of particular consumer groups, for example based on religious beliefs, such as Halal for Muslim consumers or Kosher for Jewish consumers, as well as ethical such as vegetarian or vegan, or related health concerns such as allergen-free.

Worldwide there are about 1.4 billion Muslims, of whom about 0.63 million live in Canada (1.9% of population) and about 3 million live in the United States (1% of population).[11] And there are about 14 million Jews worldwide, of whom about 0.37 million live in Canada and about 5 million lives in the United States.

While many suppliers of natural ingredients in North America already offer kosher certification, many are beginning to add Halal certification for the same ingredients. Increasingly, consumers are looking to certifications to guide them in their purchases. For natural customers, organic certification may be the most important designation but a growing number of people are looking for other assurances including religious certifications. Kosher and Halal certifications were once sought only by devoutly religious Jews or Muslims, but now demand for products with these certifications is increasing with secular consumers concerned about purity. In recent years, kosher-certified sales have increased 15% annually and about 3,000 new kosher products come on the market each year. Kosher products are also sought after by vegans, vegetarians and Seventh Day Adventists because such products are assured to be free of animal products and animal byproducts. The demand for Halal certified products is increasing and the potential is huge in America although the number of Halal certified products in the market so far is still relatively small. Among nonreligious but health-conscious consumers, the perception of Halal, like Kosher, is that the products are cleaner and healthier.[12]

In the dietary supplement sector, there has been growing awareness of the roles of Kosher and/or Halal compliance, as many active ingredients as well as excipient components are animal sourced or derived. For example, glucosamine can be vegetarian in origin, but is traditionally made from shellfish. One of the leading U.S. Halal certifiers is the Islamic Food and Nutrition Council of America (IFANCA). Run by food scientists and Islamic scholars, IFANCA looks at dietary supplement products the same way as food products. For instance, gelatin used in supplement capsules must come from animals that have been slaughtered using Halal standards. If Halal certification is granted, the company can use the “Crescent M Halal” logo on its product labels.[13]

 

3.2.2.3 Quality market access requirements (US)

Certain quality market access requirements are legislative (e.g. those specified in GMPs published in the Code of Federal Regulations) while other quality requirements are non-legislative as they are based on agreements made between the buyer and seller. The quality requirements are also dependent on the end-use of the natural ingredient. If the natural ingredient is to be used in foods or supplements the quality requirements for market access will be measurably different from the quality requirements for market access if the ingredient is going to be used in a pharmaceutical product.

Concerning quality assurance, general principles of the American Herbal Products Association (AHPA) & American Herbal Pharmacopoeia (AHP) Good Agricultural and Collection Practice for Herbal Raw Materials are as follows:[14]

Growers and collectors of herbal raw materials that are produced for use as ingredients in herbal products for human consumption must make every reasonable effort to ensure that all such ingredients are fit for their intended use. Several specific principles are essential in such efforts.

  • Identification. Whether cultivated or harvested from wild plant populations, all plant materials must be accurately identified. Usually, identification of genus and species will be sufficient to meet this demand, but any material offered as a particular subspecies, variety, cultivar, hybrid, or other lesser division of a species must in fact be that exact taxon.
  • Quality Assurance. Herbal raw materials must meet all specifications represented by accompanying certificates, by reference to standards or official compendia, and by written agreements between buyers and sellers.
  • Cleanliness. Farmers and collectors of plants used in consumer products must take necessary steps in cultivation, harvest and post-harvest practices to ensure that their herbs are not contaminated with unacceptable levels of substances that may cause harm.
  • Environmental stewardship. Growers of herbs should take steps to protect and improve the stability and quality of the topsoil that is essential to their farms’ longevity. Farm water should be used resourcefully and in a manner that protects the immediate water supply, as well as all downstream supplies. To the degree possible, growers should maintain and enhance the biodiversity of their farms. Wild plant harvesters must minimize damage to the specific populations in which they harvest and take appropriate steps to ensure survival of local plant communities. They must also protect the wildlife habitats from which they extract plant materials and recognize that many wild plants provide sources of food for wildlife.
  • Legal conformity. Both growers and wild harvesters must be aware of and in conformity with national and regional laws that govern their practices.
  • Optimal harvest conditions. For many plants that are used in consumer products, there are optimal times and conditions for planting and harvest to ensure that quality standards are met. Producers must take such factors into account when planning their raw material production.
The quality of natural ingredients is judged by the Quality Control (QC) Unit of each product manufacturing company based on a set of written specifications. According to GMP regulations, the QC Unit of a company may not release a natural ingredient for production in a batch until the ingredient has been tested and has been found to be in conformance with its written specifications.

For a natural ingredient to be permitted for use in a food product in the United States it must be classified by the U.S. Food and Drug Administration (FDA) as Generally Recognized as Safe (GRAS) for use in foods. The  FDA Center for Food Safety and Applied Nutrition (CFSAN) maintains a food additive database known as the “Everything Added to Food in the United States (EAFUS),” available on-line at: http://vm.cfsan.fda.gov/~dms/eafus.html. The EAFUS list of substances contains ingredients added directly to food that FDA has either approved as food additives or listed or affirmed as GRAS. Nevertheless, it contains only a partial list of all food ingredients that may in fact be lawfully added to food, because under federal law some ingredients may be added to food under a GRAS determination made independently from the FDA. The list contains many, but not all, of the substances subject to independent GRAS determinations. For information about the GRAS notification program please consult the Inventory of GRAS Notifications at:  http://www.cfsan.fda.gov/~rdb/opa-gras.html. Additional information on the status of Food and Color Additives can be obtained from the Food Additive Status List at: http://www.cfsan.fda.gov/~dms/opa-appa.html or the Color Additive Status List (formerly called Appendix A of the Investigations Operations Manual), available at: http://www.cfsan.fda.gov/~dms/opa-appc.html.

For natural ingredients used in cosmetic products, the FDA provides guidance on basic requirements for color additives and cosmetics at: http://www.cfsan.fda.gov/~dms/cos-col.html. The list of ingredients that are prohibited and restricted for use in cosmetics is available at: http://www.cfsan.fda.gov/~dms/cos-210.html.

For a natural ingredient to be permitted for use in a dietary supplement product there must be documentary evidence that such species was marketed in the United States prior to October 15, 1994. It is also the responsibility of finished product manufacturers and distributors to ensure that the particular natural ingredients that they use as components of dietary supplement products are safe for human consumption, do not contain contaminants, are properly identified on the label, are legally marketed, and conform to all governing regulations. Although the FDA does not endorse the American Herbal Products Associations’ (AHPA) publication “Herbs of Commerce,” 2nd Edition (2000),  for the purpose of determining whether a botanical was in U.S. commerce prior to 1994, the Herbs of Commerce does provide a very good indication that the ingredient was likely in commerce prior to 1994. If a natural ingredient was not marketed in the USA prior to 1994, it is classified as New Dietary Ingredient (NDI) and is subject to the 1997 regulation “Premarket Notification for a New Dietary Ingredient.”

For a natural ingredient to be permitted for use in an over-the-counter (OTC) or prescription drug product, the ingredient, if the active pharmaceutical ingredient, must be classified by the FDA as Generally Recognized as Safe and Effective (GRASE) and included in a positive therapeutic monograph published in the Code of Federal Regulations (CFR). The quality of active ingredients should conform to monograph. Most natural ingredients that are classified as GRASE active ingredients in the CFR monographs have corresponding quality standards monographs published in the United States Pharmacopeia (USP). Natural ingredients that are used as active pharmaceutical ingredients must be tested and released in conformance with an official quality standards monograph. Non active or excipient natural ingredient components of pharmaceutical products generally have quality standards monographs published in the USP National Formulary (USP-NF). Table 3.3 provides a listing of natural ingredients that have positive therapeutic monographs in the United States CFR.

Table 3.3:    Natural Ingredients with Positive Therapeutic Monographs in the United States Code of Federal Regulations

Natural Ingredient

Purpose of Active Ingredient

Allyl isothiocyanate (volatile oil of mustard)

Counterirritant

Compound Benzoin Tincture

Oral mucosal protectant

Bran (wheat bran)

Bulk-forming laxative

Camphor

Counterirritant; External analgesic; Topical antitussive

Capsaicin

Counterirritant; External Analgesic; Topical analgesic

Capsicum

Counterirritant; External analgesic; Topical analgesic

Capsicum Oleoresin

Counterirritant; External analgesic; Topical analgesic

Castor Oil

Stimulant laxative

Cocoa Butter

Anorectal protectant; Lip protectant; Skin protectant

Colloidal Oatmeal

Skin protectant

Corn Oil, Aqueous Emulsion

Cholecystokinetic drug; gallbladder diagnostic agent

Elm Bark

Demulcent

Gutta-Percha

Dental prosthetic material

Ipecac Oral Solution (Ipecac Syrup)

Emetic

Juniper Tar

Analgesic, Anesthetic; Antipruritic; External Analgesic

Karaya Gum (Sterculia Gum)

Bulk-forming laxative

Malt Soup Extract

Bulk-forming laxative

Menthol

Analgesic, Anesthetic (external); Anesthetic, Anesthetic (oral); Counterirritant (topical); External analgesic; Topical antitussive

Pectin

Demulcent

Plantago Seed

Bulk-forming laxative

Psyllium Hemicellulose

Bulk-forming laxative

Psyllium Hydrophyllic Mucilloid

Bulk-forming laxative

Psyllium Seed

Bulk-forming laxative

Psyllium Seed Husk

Bulk-forming laxative

Senna Fluidextract

Stimulant laxative

Senna Pod Concentrate

Stimulant laxative

Senna Oral Solution (Senna Syrup)

Stimulant laxative

Sennosides

Stimulant laxative

Soybean Oil, Hydrogenated

Cholecystokinetic drug; gallbladder diagnostic agent

Topical Starch (Corn Granules)

Anorectal protectant; Skin protectant

Turpentine Oil

Counterirritant

Witch Hazel

Astringent; Skin protectant


United States Pharmacopeia

Official monographs published in the United States Pharmacopeia – National Formulary (USP-NF) designate that the article has an FDA-approved or USP-accepted use.[17] USP-NF botanical monographs are FDA-enforceable and include descriptions, requirements, tests, analytical procedures, and acceptance criteria. USP is recognized in the Dietary Supplement Health and Education Act (DSHEA) amendments to the Federal Food, Drug and Cosmetic Act as the nation's official compendia for dietary supplement standards. The USP-NF includes three sections:

  1. USP monographs provide standards for drug substances including certain medicinal herbs and extracts;
  2. USP-DS monographs provide standards for dietary supplement ingredients; and
  3. USP-NF monographs provide standards for excipient ingredients.

Natural ingredients are represented in all three sections of the USP-NF. Table 3.4 provides a listing of natural ingredients that have USP-NF monographs, along with a designation as to which section the monograph appears in (drug, supplement, or excipient). Natural ingredients quality standards monographs of most relevance for the Malaysian export market are highlighted with yellow color.

 

 

Table 3.4:         Natural Ingredients with Quality Standards Monographs in the USP

Natural Ingredient

Species and Plant Parts

Type of Monograph

Acacia

Dried gummy exudate from the stems and branches of Acacia senegal (Linné) Willdenow or of other related African species of Acacia (Fam. Leguminosae).

USP-NF

Acacia Syrup

Prepared with Acacia, Sodium Benzoate, Sucrose, Purified Water, and Vanilla Tincture.

USP-NF

Agar

Dried, hydrophilic, colloidal substance extracted from Gelidium cartilagineum (Linné) Gaillon (Fam. Gelidiaceae), Gracilaria confervoides (Linné) Greville (Fam. Sphaerococcaceae), and related red algae (Class Rhodophyceae).

USP-NF

Aloe

Dried latex of the leaves of Aloe barbadensis Miller (Aloe vera Linné), known in commerce as Curaçao Aloe, or of Aloe ferox Miller and hybrids of this species with Aloe africana Miller and Aloe spicata Baker, known in commerce as Cape Aloe (Fam. Liliaceae).

USP

American Ginseng

Dried roots of Panax quinquefolius L. (Fam. Araliaceae).

USP-DS

American Ginseng Extract Powdered

Prepared from the pulverized dried roots of Panax quinquefolius L. (Fam. Araliaceae), using suitable solvents, and dried to a powder.

USP-DS

Anethole

Obtained from Anise Oil and other sources, or is prepared synthetically.

USP-NF

Anise Oil

Volatile oil distilled with steam from the dried, ripe fruit of Pimpinella ansium L. (Fam. Apiaceae) or from the dried ripe fruit of Illicium verum Hook. f. (Fam. Illiciaceae).

USP-NF

Asian Ginseng

Dried roots of Panax ginseng C.A. Meyer (Fam. Araliaceae).

USP-DS

Asian Ginseng Extract Powdered

Prepared from Asian Ginseng by maceration, percolation, or both processes performed at room temperature with suitable solvents such as alcohol, methanol, water, or mixtures of these solvents, and by concentrating the fluidextract at temperatures below 50º.

USP-DS

Belladonna Leaf

Dried leaf and flowering or fruiting top of Atropa belladonna Linné or of its variety acuminata Royle ex Lindley (Fam. Solanaceae).

USP

Belladonna Extract

Contains, in each 100 g, not less than 1.15 g and not more than 1.35 g of the alkaloids of belladonna leaf.

USP

Belladonna Tincture

Yields, from each 100 mL, not less than 27 mg and not more than 33 mg of the alkaloids of belladonna leaf.

USP

Benzoin

Balsamic resin obtained from Styrax benzoin Dryander or Styrax paralleloneurus Perkins, known in commerce as Sumatra Benzoin, or from Styrax tonkinensis (Pièrre) Craib ex Hartwich, or other species of the Section Anthostyrax of the genus Styrax, known in commerce as Siam Benzoin (Fam. Styraceae).

USP

Benzoin Compound Tincture

Prepared from Benzoin, Aloe, Storax, and Tolu Balsam.

USP

Black Cohosh

Dried rhizome and roots of Actaea racemosa L. [Cimicifuga racemosa (L.) Nutt.] (Fam. Ranunculaceae).

USP-DS

Black Cohosh

Fluid extract

Prepared from Black Cohosh by extraction with hydroalcoholic mixtures or isopropanol–water mixtures.

USP-DS

Black Cohosh Extract Powdered

Prepared from Black Cohosh by extraction with hydroalcoholic mixtures or other suitable solvents

USP-DS

Camphor

Ketone obtained from Cinnamomum camphora (Linné) Nees et Ebermaier (Fam. Lauraceae) (Natural Camphor).

USP

Camphor Spirit

Alcohol solution containing, in each 100 mL, not less than 9.0 g and not more than 11.0 g of camphor (C10H16O).

USP

Candelilla Wax

Purified wax obtained from the leaves of the candelilla plant, 
Euphorbia antisyphilitica.

USP-NF

Capsicum

Dried ripe fruit of Capsicum frutescens Linné, known in commerce as African Chillies, or of Capsicum annuum Linné var. connoides Irish, known in commerce as Tabasco Pepper, or Capsicum annuum var. longum Sendt, known in commerce as Louisiana Long Pepper, or of a hybrid between the Honka variety of Japanese Capsicum and the Old Louisiana Sport Capsicum known in commerce as Louisiana Sport Pepper (Fam. Solanaceae).

USP

Capsicum Oleoresin

Alcoholic extract of the dried ripe fruits of Capsicum annum var. minimum and small fruited varieties of C. frutescens (Solanaceae).

USP

Caraway

Dried, ripe fruit of Carum carvi L. (Fam. Apiaceae).

USP-NF

Caraway Oil

Volatile oil distilled from the dried, ripe fruit of Carum carvi L. (Fam. Apiaceae).

USP-NF

Cardamom Oil

Volatile oil distilled from the seed of Elettaria cardamomum (L.) Maton (Fam. Zingiberaceae).

USP-NF

Cardamom Seed

Dried ripe seed of Elettaria cardamomum (L.) Maton (Fam. Zingiberaceae).

USP-NF

Cardamom Tincture Compound

Prepared with Cardamom, Cinnamon, Caraway, Glycerin and Diluted Alcohol.

USP-NF

Carnauba Wax

Obtained from the leaves of Copernicia cerifera Mart. (Fam. Palmae).

USP-NF

Carrageenan

Hydrocolloid obtained by extraction with water or aqueous alkali, from some members of the class Rhodophyceae (red seaweeds).

USP-NF

Cascara Sagrada

Dried bark of Rhamnus purshiana De Candolle (Fam. Rhamnaceae).

USP

Cascara Sagrada
Extract

Prepared with boiling water by maceration and percolation.

USP

Cascara Sagrada 

 Fluidextract

Prepared with boiling water by maceration and percolation; alcohol added.

USP

Cascara Sagrada

Aromatic Fluidextract

Prepared with Magnesium Oxide, sweeteners, essential oils, alcohol, and Purified Water.

USP

Castor Oil

Fixed oil obtained from the seed of Ricinus communis Linné (Fam. Euphorbiaceae).

USP +

USP-NF

Castor Oil, Aromatic

Castor Oil containing suitable flavoring agents. It contains not less than 95.0 percent of castor oil.

USP

Chamomile

Dried flower heads of Matricaria recutita Linné (Matricaria chamomilla Linné, Matricaria chamomilla Linné var. courrantiana, Chamomilla recutita Linné) Rauschert (Fam. Asteraceae alt. Compositae).

USP-DS


 

 

Chaste Tree

Dried ripe fruits of Vitex agnus-castus L. (Fam. Verbenaceae).

USP-DS

Chaste Tree Extract

Powdered

Prepared from Chaste Tree by extraction with hydroalcoholic mixtures or other suitable solvents.

USP-DS

Cherry Juice

Liquid expressed from the fresh ripe fruit of Prunus cerasus L. (Fam. Rosaceae).

USP-NF

Chocolate

Powder prepared from the roasted, cured kernels of the ripe seed of 
Theobroma cacao L. (Fam. Sterculiaceae).

USP-NF

Clove Oil

Volatile oil distilled with steam from the dried flower buds of 
Syzygium aromaticum (L.) Merr. and L. M. Perry (Fam. Myrtaceae).

USP-NF

Cocoa Butter

Fat obtained from the seed of Theobroma cacao Linné (Fam. Sterculiaceae).

USP-NF

Coconut Oil

Refined fixed oil obtained from the seeds of Cocos nucifera Linné (Fam. Palmae).

USP-NF

Coriander Oil

Volatile oil obtained by steam distillation from the dried ripe fruit of
Coriandrum sativum
L. (Fam. Apiaceae).

USP-NF

Cod Liver Oil

Partially destearinated fixed oil obtained from fresh livers of Gadus morrhua Linné and other species of Fam. Gadidae.

USP +

USP-DS

Colloidal Oatmeal

Powder resulting from the grinding and further processing of whole oat grain meeting U.S. Standards for Number 1 or Number 2 oats (7 CFR 810.1001).

USP

Cranberry Liquid

Preparation

Bright red juice derived from the fruits of Vaccinium macrocarpon Ait. or Vaccinium oxycoccos Linné (Fam. Ericaceae).

USP-DS

Digitalis

Dried leaf of Digitalis purpurea Linné (Fam. Scrophulariaceae).

USP

Digitoxin

Cardiotonic glycoside obtained from Digitalis purpurea Linné, Digitalis lanata Ehrhart (Fam. Scrophulariaceae), and other suitable species of Digitalis.

USP

Digoxin

Cardiotonic glycoside obtained from the leaves of Digitalis lanata Ehrhart (Fam. Scrophulariaceae).

USP

Echinacea angustifolia

Dried rhizome and roots of Echinacea angustifolia DC. (Fam. Asteraceae).

USP-DS

Echinacea angustifolia

Extract, Powdered

Prepared from Echinacea angustifolia roots by extraction with hydroalcoholic mixtures or other suitable solvents.

USP-DS

Echinacea pallida

Dried rhizome and roots of Echinacea pallida (Nutt.) Nutt. (Fam. Asteraceae).

USP-DS

Echinacea pallida

Extract, Powdered

Prepared from Echinacea pallida roots by extraction with hydroalcoholic mixtures or other suitable solvents.

USP-DS

Echinacea purpurea

Aerial Parts

Flowering aerial parts of Echinacea purpurea (L.) Moench (Fam. Asteraceae).

USP-DS

Echinacea purpurea

Root

Dried rhizome and roots of Echinacea purpurea (L.) Moench (Fam. Asteraceae).

USP-DS

Echinacea purpurea
Extract, Powdered

prepared from dried Echinacea purpurea Root, Echinacea purpurea Aerial Parts, or a mixture of them, by extraction with hydroalcoholic mixtures or other suitable solvents.

USP-DS

Eleuthero

Dried rhizome with roots of Eleutherococus senticosus (Rupr. et Maxim.) (Fam. Araliaceae) [Acanthopanax senticosus Harms].

USP-DS

Eleuthero Extract

Powdered

Dried rhizome with roots of Eleutherococus senticosus (Rupr. et Maxim.) (Fam. Araliaceae) [Acanthopanax senticosus Harms].

USP-DS

Elm

Dried inner bark of Ulmus rubra Muhlenberg (Ulmus fulva Michaux) (Fam. Ulmaceae).

USP +

USP-DS

Eucalyptol

Obtained from oil of eucalyptus and from other sources.

USP

Eugenol

Obtained from Clove Oil and from other sources.

USP

Fennel Oil

Volatile oil distilled with steam from the dried, ripe fruit of Foeniculum vulgare Mill. (Fam. Apiaceae).

USP-NF

Feverfew

Dried leaves of Tanacetum parthenium (Linné) Schultz-Bip. (Fam. Asteraceae), collected when the plant is in flower.

USP-DS

Galageenan

Hydrocolloid obtained by extraction with water or aqueous alkali from the red seaweed class Rhodophyceae species Eucheuma gelatinae.

USP-NF

Garlic

Fresh or dried compound bulbs of Allium sativum Linné (Fam. Liliaceae).

USP-DS

Garlic Extract

Powdered

Prepared from fresh Garlic bulbs by extraction with alcohol.

USP-DS

Garlic Fluidextract

Prepared Garlic, whole or sliced, in a volume of a mixture of water and alcohol (between 80:20 and 50:50) sufficient to cover the cloves.

USP-DS

Ginger

Rhizome of Zingiber officinale Roscoe (Fam. Zingiberaceae), scraped or unscraped.

USP-DS

Ginger Tincture

Prepared by the Maceration Process as directed for Tinctures under Botanical Extracts <566>

USP-DS

Ginkgo

Dried leaf of Ginkgo biloba Linné (Fam. Ginkgoaceae).

USP-DS

Ginkgo Extract

Powdered

Prepared from dried and comminuted leaves of Ginkgo extracted with an acetone–water mixture or other suitable solvents.

USP-DS

Goldenseal

Dried roots and rhizomes of Hydrastis canadensis L. (Fam. Ranunculaceae).

USP-DS

Goldenseal Extract

Powdered

Prepared from the pulverized dried roots and rhizomes of Hydrastis canadensis L. (Fam. Ranunculaceae) using suitable solvents.

USP-DS

Guar Gum

Gum obtained from the ground endosperms of Cyamopsis tetragonolobus (Linné) Taub. (Fam. Leguminosae).

USP-NF

Gutta-percha

Coagulated, dried, purified latex of the trees of the genera Palaquium and Payena and most commonly Palaquium gutta (Hooker) Baillon (Fam. Sapotaceae).

USP

Hawthorn Leaf with

Flower

Dried tips of the flower-bearing branches up to 7 cm in length of 
Crataegus monogyna Jacq. emend Lindman. or Crataegus laevigata (Poir.) DC., also known as Crataegus oxycantha Linné (Fam. Rosaceae).

USP-DS

Horse Chestnut

Dried seeds of Aesculus hippocastanum L. (Fam. Hippocastanaceae).

USP-DS

Horse Chestnut

Extract, Powdered

Prepared from Horse Chestnut by extraction with alcohol–water mixtures or methanol–water mixtures.

USP-DS

Ipecac

Dried rhizome and roots of Cephaëlis acuminata Karsten, or of 
Cephaëlis ipecacuanha (Brotero) A. Richard (Fam. Rubiaceae).

USP

Ipecac Oral Solution

Prepared by percolation with alcohol and water; glycerin added.

USP

Juniper Tar

Empyreumatic volatile oil obtained from the woody portions of 
Juniperus oxycedrus Linné (Fam. Pinaceae).

USP +

USP-NF

Lemon Oil

Volatile oil obtained by expression, without the aid of heat, from the fresh peel of the fruit of Citrus x limon (L.) Osbeck (Fam. Rutaceae), with or without the previous separation of the pulp and the peel.

USP-NF

Lemon Peel

Tincture

prepared from lemon peel, which is the outer yellow rind of the fresh, ripe fruit 
of Citrus x Limon Osbeck (Fam. Rutaceae).

USP-NF

Licorice

Roots, rhizomes, and stolons of Glycyrrhiza glabra Linné or 
Glycyrrhiza uralensis Fisher (Fam. Leguminosae).

USP-DS

Licorice Extract

Powdered

Prepared from comminuted Licorice extracted with water or suitable solvents such as alcohol, water, or mixtures of these solvents.

USP-DS

Licorice Fluidextract

Prepared with boiling Purified Water; Alcohol added.

USP-DS + USP-NF

Maritime Pine

Bark of stems of Pinus pinaster Aiton (Pinus maritima Poir.) Fam. Pinaceae.

USP-DS

Maritime Pine Extract

Prepared from the pulverized Maritime Pine using suitable solvents.

USP-DS

Menthol

Alcohol obtained from diverse mint oils or prepared synthetically. Menthol 
may be levorotatory (l-Menthol), from natural or synthetic sources, or racemic (dl-Menthol).

USP

Milk Thistle

Dried ripe fruit of Silybum marianum (L.) Gaertn. (Fam. Asteraceae), the pappus having been removed.

USP-DS

Milk Thistle Extract

Powdered

Prepared from Milk Thistle fruits or seeds by fat removal and subsequent extraction with suitable solvents.

USP-DS

Myrrh

Oleo-gum resin obtained from stems and branches of Commiphora molmol Engler and other related species of Commiphora other than Commiphora mukul (Fam. Burseraceae).

USP

Myrrh Topical Solution

Prepared by maceration with an alcohol-water mixture.

USP

Nystatin

Substance, or a mixture of two or more substances, produced by the growth of Streptomyces noursei Brown et al. (Fam. Streptomycetaceae).

USP

Olive Oil

Fixed oil obtained from the ripe fruit of Olea europaea Linné (Fam. Oleaceae). It may contain suitable antioxidants.

USP-NF

Opium

Air-dried milky exudate obtained by incising the unripe capsules of 
Papaver somniferum Linné or its variety album De Candolle (Fam. Papaveraceae).

USP

Opium Tincture

Prepared with granulated or sliced Opium by percolation with water; alcohol is added.

USP

Orange Oil

Volatile oil obtained by expression from the fresh peel of the ripe fruit of 
Citrus sinensis
L. Osbeck (Fam. Rutaceae).

USP-NF

Orange Spirit

Compound

Prepared from Orange Oil, Lemon Oil, Coriander Oil, Anise Oil, and Alcohol.

USP-NF

Palm Kernel Oil

Refined fixed oil obtained from the kernel of the fruit of the oil palm 
Elaeis guineensis Jacq. (Fam. Arecaceae). It may contain suitable antioxidants.

USP-NF

Papain

Purified proteolytic substance derived from Carica papaya Linné (Fam. Caricaceae).

USP

Pectin

Purified carbohydrate product obtained from the dilute acid extract of the inner portion of the rind of citrus fruits or from apple pomace.

USP +

USP-NF

Peppermint

Dried leaf and flowering top of Mentha piperita Linné (Fam. Labiatae).

USP-NF

Peppermint Oil

Volatile oil distilled with steam from the fresh overground parts of the flowering plant of Mentha piperita Linné (Fam. Labiatae), rectified by distillation and neither partially nor wholly dementholized.

USP-NF

Peppermint Spirit

Prepared by macerating Peppermint leaf in purified water and alcohol; Peppermint essential oil is added.

USP +

USP-NF

Peppermint Water

Clear, saturated solution of Peppermint Oil in Purified Water.

USP-NF

Plantago Seed

Cleaned, dried, ripe seed of Plantago psyllium Linné, or of Plantago indica Linné (Plantago arenaria Waldstein et Kitaibel), known in commerce as Spanish or French Psyllium Seed; or of Plantago ovata Forskal, known in commerce as Blond Psyllium or Indian Plantago Seed (Fam. Plantaginaceae).

USP

Psyllium

Hemicellulose

Alkali soluble fraction of the husk from Plantago ovata Forssk.

USP

Psyllium Husk

Cleaned, dried seed coat (epidermis) separated by winnowing and thrashing from the seeds of Plantago ovata Forssk., known in commerce as Blond Psyllium or Indian Psyllium or Ispaghula, or from Plantago arenaria Waldst. & Kit. (Plantago psyllium L.) known in commerce as Spanish or French Psyllium (Fam. Plantaginaceae), in whole or in powdered form.

USP

Purified Honey

Obtained by purification of honey from the comb of the bee, Apis mellifera L. and all subspecies of Apis mellifera.

USP-NF

Pygeum

Bark of Prunus africana (Hook f.) Kalkman (Pygeum africanum Hook f.) Rosaceae.

USP-DS

Pygeum Extract

Prepared from pulverized Pygeum, using suitable solvents.

USP-DS

Quinidine Gluconate

Gluconate of an alkaloid that may be obtained from various species of Cinchona and their hybrids, or from Remijia pedunculata Flückiger (Fam. Rubiaceae), or prepared from quinine.

USP

Quinidine Sulfate

Sulfate of an alkaloid obtained from various species of Cinchona and their hybrids and from Remijia pedunculata Flückiger (Fam. Rubiaceae), or prepared from quinine.

USP

Quinine Sulfate

Sulfate of an alkaloid obtained from the bark of species of Cinchona.

USP

Rauwolfia Serpentina

Dried root of Rauwolfia (Linné) Bentham ex Kurz (Fam. Apocynaceae), sometimes having fragments of rhizome and aerial stem bases attached.

USP

Red Clover

Dried inflorescence of Trifolium pratense L. (Fam. Fabaceae).

USP-DS

Red Clover Extract

Powdered

Prepared from Red Clover by extraction with hydroalcoholic mixtures or other suitable solvents.

USP-DS

Rose Oil

Volatile oil distilled with steam from the fresh flowers of Rosa gallica Linné, Rosa damascena Miller, Rosa alba Linné, Rosa centifolia Linné, and varieties of these species (Fam. Rosaceae).

USP-NF

Saw Palmetto

Partially dried, ripe fruit of Serenoa repens (Bartram) Small (Fam. Arecaceae) [Serenoa serrulatum Schultes; Sabal serrulata (Michaux) Nichols].

USP-DS

Saw Palmetto Extract

Obtained from comminuted Saw Palmetto by extraction with hydroalcoholic mixtures or solvent hexane, or by supercritical extraction with carbon dioxide.

USP-DS

Senna Leaf

Dried leaflet of Senna alexandrina Mill also known as Cassia acutifolia Delile (Alexandrian senna) or C. angustifolia Vahl (Tinnevelly senna) (Fam. Fabaceae).

USP

Senna Fluidextract

Prepared with alcohol and water by percolation.

USP

Senna Pods

Dried ripe fruits of Senna alexandrina Mill also known as Cassia acutifolia Delile (Alexandrian senna) or C. angustifolia Vahl (Tinnevelly senna) (Fam. Fabaceae).

USP

Senna Oral Solution

Prepared with Senna Fluidextract, essential oils, sucrose, and purified water.

USP

Sennosides

Partially purified natural complex of anthraquinone glucosides, isolated from senna leaflets and/or senna pods, Senna alexandrina Mill (Cassia acutifolia or C. angustifolia), as calcium salts.

USP

Shellac

Obtained by the purification of Lac, the resinous secretion of the insect 
Laccifer Lacca Kerr (Fam. Coccidae).

USP-NF

Soybean Oil

Refined fixed oil obtained from the seeds of the soya plant Glycine max Merr. (Fabaceae). It may contain suitable antioxidants.

USP

Soybean Oil

Hydrogenated

obtained by refining, bleaching, hydrogenation, and deodorization of oil obtained from seeds of the soya plant Glycine max Merr. (Fabaceae).

USP-NF

Stinging Nettle

Dried roots and rhizomes of Urtica dioica L. ssp dioica (Fam. Urticaceae), and may contain Urtica urens L., known in commerce as dwarf nettle, as a minor component.

USP-DS

Stinging Nettle Extract

Powdered

Prepared from comminuted Stinging Nettle with 60 percent alcohol or other suitable solvents.

USP-DS

St. John’s Wort

Dried flowering tops or aerial parts of Hypericum perforatum Linné (Fam. Hypericaceae), gathered shortly before or during flowering.

USP-DS

St. John’s Wort Extract

Powdered

Prepared from comminuted St. John's Wort extracted with 80 percent methanol or other suitable solvents.

USP-DS

Storax

Balsam obtained from the trunk of Liquidambar orientalis Miller, known in commerce as Levant Storax, or of Liquidambar styraciflua Linné, known in commerce as American Storax (Fam. Hamamelidaceae).

USP

Stronger Rose Water

Saturated solution of the odoriferous principles of the flowers of Rosa centifolia Linné (Fam. Rosaceae).

USP-NF

Sweet Orange Peel

Tincture

Prepared from sweet orange peel, which is the outer rind of the non-artificially colored, fresh, ripe fruit of Citrus sinensis (L.) Osbeck (Fam. Rutaceae).

USP-NF

Tolu Balsam

Balsam obtained from Myroxylon balsamum (Linné) Harms (Fam. Leguminosae).

USP +

USP-NF

Tolu Balsam Tincture

Prepared from Tolu Balsam obtained from Myroxylon balsamum (L.) Harms 
var. balsamum
(Fam. Fabaceae).

USP-NF

Tomato Extract

Containing Lycopene

Ethyl acetate extract of the natural tomato lipids produced from the pulp of ripe fruits of Lycopersicon esculentum Mill. (Fam. Solanaceae), after removing the tomato serum.

USP-DS

Topical Starch

Granules separated from the mature grain of corn [Zea mays Linné (Fam. Gramineae)].

USP

Tragacanth

Dried gummy exudation from Astragalus gummifer Labillardière, or other Asiatic species of Astragalus (Fam. Leguminosae).

USP-NF

Valerian

Subterranean parts of Valeriana officinalis Linné (Fam. Valerianaceae) including the rhizome, roots, and stolons.

USP-DS

Valerian Extract

Powdered

Prepared from comminuted Valerian and with 70 percent alcohol or other suitable solvents.

USP-DS

Vanilla

Cured, full-grown, unripe fruit of Vanilla planifolia Jacks., often known in commerce as Mexican, Bourbon, or Madagascar vanilla, or of Vanilla tahitensis J.W. Moore, known in commerce as Tahitian vanilla (Fam. Orchidaceae).

USP-NF

Vanilla Tincture

Prepared from cut Vanilla pieces, purified water, alcohol, sucrose granules, and diluted alcohol.

USP-NF

Wheat Bran

Outer fraction of the cereal grain, comprising the pericarp, seed coat (testa), nucellar tissue, and aleurone layer, and is derived from Triticum aestivum Linné, T. compactum Host, T. durum Desf., and other common einkorn and emmer wheat cultivars.

USP

Witch Hazel

Clear, colorless distillate prepared from recently cut and partially dried dormant twigs of Hamamelis virginiana Linné.

USP


For many other natural ingredients used in the U.S. there are not yet official quality standards monographs published by the USP. Therefore other authoritative quality standards monographs are also utilized by industry including the European Pharmacopoeia (PhEur), the Japanese Pharmacopoeia (JP), and the Pharmacopoeia of the People’s Republic of China (PPRC), as well as certain non-official pharmacopoeias such as the American Herbal Pharmacopoeia (AHP) and the British Herbal Pharmacopoeia (BHP). Below is a list of monographs that have been published by the AHP with an internet link for more information:


3.2.3 Packaging, marking and labeling (US)

Depending on the specific natural ingredient(s) being imported into the USA, one or more governmental agencies may become involved in the inspection of the imported goods, their packaging, labeling and related documentation, including the Animal and Plant Health Inspection Service (APHIS), Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), Food Safety Inspection Service (FSIS), United States Department of Agriculture (USDA), and the US Customs Service.

In addition to legal requirements for the packaging and labeling of imported ingredients, importers are likely to have their own specific, additional packaging and labeling requirements, for example requirements that the seller’s lot number is stenciled on each sack or drum, as well as the buyer’s item code number and the purchase order number. The buyer may also specify the packaging type (e.g. poly-lined 55 gallon fiber drum) and the pallet type and configuration. In general, natural ingredients should be packed in tightly sealed, lined containers that will protect against cross-contamination, spillage, moisture damage, and insect infestation. Basic labeling requirements include:

  • English name of the ingredient English name of country of origin
  • Name and address of the producer
  • Gross weight
  • Net and tare weights
  • Vendor’s lot number (must match lot number on packing list)
  • Any other information requested by the buyer (e.g. buyer’s item code)


Organic ingredient labeling

If the imported natural ingredient is certified organic, the following USDA National Organic Program (NOP) regulations may also apply:

§ 205.307 Labeling of nonretail containers used for only shipping or storage of raw or processed agricultural products labeled as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))."

(a) Nonretail containers used only to ship or store raw or processed agricultural product labeled as containing organic ingredients may display the following terms or marks:

(1) The name and contact information of the certifying agent which certified the handler which assembled the final product;

(2) Identification of the product as organic;

(3) Special handling instructions needed to maintain the organic integrity of the product;

(4) The USDA seal;

(5) The seal, logo, or other identifying mark of the certifying agent that certified the organic production or handling operation that produced or handled the finished product.

(b) Nonretail containers used to ship or store raw or processed agricultural product labeled as containing organic ingredients must display the production lot number of the product if applicable.

USDA National Organic Program (NOP) regulations are available online at: http://www.ams.usda.gov/nop/NOP/NOPhome.html.


Ingredient nomenclature

Cosmetic ingredients must use nomenclature found in the International Cosmetic Ingredient Dictionary and Handbook published by the Cosmetic Toiletries and Fragrance Association (CTFA).[18]

Dietary supplement regulations require product ingredients labeling to be consistent with the Standard Common Names (SCN) as defined in the American Herbal Products Association’s Herbs of Commerce.[19]

Pharmaceutical ingredients should be labeled as per the name used the therapeutic monograph published in the Code of Federal Regulations (CFR) and/or as per the corresponding quality standards monograph published in the United States Pharmacopeia (USP).


Country of origin marking requirements

Every article of foreign origin entering the US must be legibly marked with the English name of the country of origin unless an exception from marking is provided for in the law. The marking must be legible, of an adequate size, and clear enough, to be read easily by a person of normal vision. The marking should be located in a conspicuous place, where it can be seen with a casual handling of the article. Abbreviations that unmistakably indicate the name of a country, such as “Gt. Britain” for Great Britain or “Luxemb” for Luxembourg, are acceptable. Variant spellings which clearly indicate the English name of the country of origin, such as “Brasil” for Brazil and “Italie” for Italy are acceptable. However, it is always preferable to spell out the country’s name in full, because any abbreviation may be a cause for confusion. However, “E.C.” or “E.U.” for European Community or European Union, respectively, are not acceptable abbreviations since they do not indicate the individual country of origin of the good.

The best form of marking is one which becomes a part of the article itself, such as branding, stenciling, stamping, printing, molding, and similar methods. Other forms of marking, such as adhesive labels, also will be acceptable if it is certain that the marking will remain legible and conspicuous until the article reaches the ultimate purchaser in the United States. When tags are used, they must be attached in a conspicuous place and in a manner which assures that, unless deliberately removed, they will remain on the article until it reaches the ultimate purchaser.[20]

 

FDA notification

To ensure that FDA is notified of all regulated products imported into the US, the importer, or his/her representative, must file an entry notice and an entry bond with the US Customs Service (Customs) pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs. FDA is notified by Customs of the entry and makes a decision as to the article's admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into US commerce.

 

Role of USDA

USDA regulatory activities are enforced by the Animal and Plant Health Inspection Service (APHIS), the Food Safety Inspection Service (FSIS), and Agricultural Marketing Service (AMS), among other agencies.  In addition, the US Customs Service participates by the detaining of imports when USDA requirements have not been met. APHIS is responsible for enforcing regulations governing the import and export of plants and animals and certain agricultural products. APHIS import requirements depend on both the product and the country of origin. Plants and plant materials usually must be accompanied by a phytosanitary certificate issued by an official of the exporting country.


US Customs Service

The US Customs Service cooperates with a number of other Federal agencies, and a license or permit from the responsible agency is necessary to import a range of products including plants and plant products.

Guidance from American Herbal Products Association and American Herbal Pharmacopoeia

The following useful information on packaging, labeling, and storage of botanical raw materials is excerpted from Chapter 3.8 of the American Herbal Products Association (AHPA) and American Herbal Pharmacopoeia (AHP) Good Agricultural and Collection Practice (GACP) for Herbal Raw Materials: [21]

The use of adequate packaging equipment and materials will affect the quality of packaged herbal crops, as will storage conditions. The following practices are relevant to packaging (including drums, boxes, bags and all other packaging) and storage operations for bulk herbs.

  • Packaging materials. Use only food- or pharmaceutical-grade packaging materials. Do not reuse any packaging material, except that packaging material that includes recycled material is acceptable so long as the recycling process results in packaging material that maintains food-grade or pharmaceutical-grade status.
  • Conformity to specifications. Use only packaging material that conforms to the product’s packaging specifications, if any. For example, high volatile-oil-containing herbs should be stored in non-plastic containers.
  • · Package labeling. Label all packages to identify the contents by the plant name (both by its common English name* and by its scientific binomial name); the part of the plant; the form of the material (e.g., “whole,” “teabag cut,” “powder,” etc.); the name and contact information of the grower and/or the distributor; the country of harvest or collection; a date of production; the quantity by weight in the package; the item number (if any); the identity and quantity or proportion of any substances added to the material, if any (e.g., anticaking or flow agents used in a milling operation); and a lot number. Labels must be clearly printed, permanently affixed, and conform to any labeling regulations in the country in which the material was produced and in any countries to which it is intended to be shipped. (Note:* If the species is listed in the American Herbal Products Association’s Herbs of Commerce, 2nd Edition, the standardized common name in that reference should always be used.)
  • Storage. Store packaged herbal crops in cool, dry areas away from direct sunlight and exterior walls and off the ground in containers that protect against excessive exposure to air, light, and moisture. Storage facilities should be dry, well ventilated, and have sufficient insulation or other temperature-control features to avoid extreme temperature fluctuations.
  • Separation from non-food storage. Segregate packaged herbal materials in different areas from non-food items.
  • Control of odor absorption. Segregate herbal materials that are high in essential oils so that other herbs do not inadvertently absorb their odors. For example, peppermint leaf should not be stored in close confinement with black tea leaf.

 

3.2.4 Tariffs and quota (US)

The USITC (Office of Tariff Affairs and Trade Agreements) is responsible for publishing the Harmonized Tariff Schedule of the United States Annotated (HTSA). The HTSA provides the applicable tariff rates and statistical categories, based on the international Harmonized System, for all natural ingredients imported into the US. The US Customs Service is responsible for administering the tariff and for processing import entries. The USITC Tariff Information Center which provides the current HTSA is available on-line at: http://www.usitc.gov/tata/hts/bychapter/index.htm.

Additionally, the Market Access Map is available through the International Trade Centre (ITC) website and was developed by the ITC in collaboration with Centre d'Etudes Prospectives et d'Informations Internationales (CEPII), UNCTAD, and World Trade Organization (WTO). The ITC offers a 2-day free trial of the Market Access Map at: http://www.macmap.org.[22]

Table 3.5 shows the applied tariffs for selected product codes for exporter Malaysia to importer United States of America. Trade regime description: Most Favored Nation (MFN) duties applied.

Table 3.5 Importer USA applies the following tariffs to imports of these selected natural ingredients originating from exporter Malaysia

Selected

HS Codes

Product description

Applied tariffs

Ad valorem equivalent

of specific applied tariffs

Total

ad valorem equivalent

tariff (estimated)

070320

Garlic, fresh or dried

$4.30 / Ton

0.12%

0.12%

07129040

Dried garlic

29.80%

 

29.80%

08029012

Betel nut

$50.00 / Ton

0.35%

0.35%

0804.5040

Mangosteen fruit, fresh

(1 Sept through 31 May)

$66.00 / Ton

7.93%

7.93%

0804.5060

Mangosteen fruit, fresh

(1 June through 31 August)

$66.00 / Ton

4.92%

4.92%

0804.5080

Mangosteen fruit, Dried

$15.00 / Ton

0.24%

0.24%

0902

Green tea or black tea, unflavored

0.00%

 

0.00%

090411

090412

Piper genus fruits, except cubeb pepper

0.00%

 

0.00%

09042020

Paprika, dried, crushed or ground

$30.00 / Ton

0.73%

0.73%

09042076

Capsicum genus fruits, ground, NESOI

$50.00 / Ton

1.55%

1.55%

09042080

Pimenta genus fruits, dried, crushed or ground

0.00%

 

0.00%

0906

Cinnamon

0.00%

 

0.00%

0907

Cloves

2.80%

 

2.80%

090810

Nutmeg

0.00%

 

0.00%

09082020

Mace, Bombay or wild, ground

$74.00 / Ton

1.02%

1.02%

09082040

Mace, other than ground Bombay or wild mace

0.00%

 

0.00%

090830

Cardamoms

0.00%

 

0.00%

090910

Star anise fruit

0.00%

 

0.00%

090920

Coriander fruit

0.00%

 

0.00%

090930

Cumin fruit

0.00%

 

0.00%

090940

Caraway fruit

0.00%

 

0.00%

090950

Fennel fruit

0.00%

 

0.00%

09101020

Ginger rhizome, not ground

0.00%

 

0.00%

09101040

Ginger rhizome, ground

$10.00 / Ton

0.42%

0.42%

091030

Turmeric rhizome

0.00%

 

0.00%

091050

Curry powder

0.00%

 

0.00%

091091

Spice mixtures

1.90%

 

1.90%

09109960

Spices NESOI

1.90%

 

1.90%

121010

Hop strobile, whole

$132.00 / Ton

2.16%

2.16%

121020

Hop strobile, ground, powdered, or pellets

$132.00 / Ton

2.59%

2.59%

121110

Licorice root

0.00%

 

0.00%

1221120

Ginseng roots

0.00%

 

0.00%

12119020

Mint leaves, crude or not manufactured

0.00%

 

0.00%

12119040

Mint leaves NESOI

4.80%

 

4.80%

12119060

Tonka beans

$66.00 / Ton

0.43%

0.43%

121190

Medicinal plants NESOI

0.00%

 

0.00%

121220

Seaweeds and other algae

0.00%

 

0.00%

13019040

Turpentine gum (oleoresinous exudate)

1.30%

 

1.30%

130190

Natural gums, resins, gum-resins and balsams, NESOI

0.00%

 

0.00%

13021940

Ginseng extract

1.00%

 

1.00%

13021990

Vegetable saps and extracts NESOI

0.00%

 

0.00%

130231

Agar-agar

0.00%

 

0.00%

130239

Mucilages & thickeners NESOI

3.20%

 

3.20%

140490

Vegetable products NESOI

0.00%

 

0.00%

151311

Coconut oil, crude

0.00%

 

0.00%

151319

Coconut oil, refined

0.00%

 

0.00%

180400

Cocoa butter, fat and oil

0.00%

 

0.00%

21012020

Tea or maté extracts, essences & concentrations & preparations thereof

0.00%

 

0.00%

21012032

Preparations with a basis of extracts/essences/concentrates of tea or maté

10.00%

 

10.00%

21012038

Blend syrup preparation with basis of extract/essence/concentrate of tea or maté

8.50% + $350.00 / Ton

9.22%

17.72%

21012048

Preparation of 65% sugar w/basis of extract/essence/concentrate of tea or maté

8.50% + $305.00 / Ton

6.15%

14.65%

21012090

Preparations NESOI w/basis of extract/essence/concentrate of tea or maté

8.50%

 

8.50%

293921

Quinine and its salts, in bulk

0.00%

 

0.00%

293929

Cinchona alkaloids and their derivatives, in bulk; salts thereof

0.00%

 

0.00%

330111

Essential oils of bergamot

0.00%

 

0.00%

330112

Essential oils of orange

2.70%

 

2.70%

330113

Essential oils of lemon

3.80%

 

3.80%

330114

Essential oils of lime

0.00%

 

0.00%

33011910

Essential oils of grapefruit

2.70%

 

2.70%

33011950

Essential oils of citrus fruit NESOI

0.00%

 

0.00%

33012100

Essential oils of geranium

0.00%

 

0.00%

33012200

Essential oils of jasmine

0.00%

 

0.00%

33012300

Essential oils of lavender

0.00%

 

0.00%

33012400

Essential oils of peppermint

4.20%

 

4.20%

33012500

Essential oil of other mints

0.00%

 

0.00%

33012600

Essential oils of vetiver

0.00%

 

0.00%

33012910

Essential oils of eucalyptus

1.80%

 

1.80%

33012920

Essential oils of orris

1.10%

 

1.10%

33012950

Essential oils other than those of Citrus fruits NESOI

0.00%

 

0.00%

33013000

Resinoids

0.00%

 

0.00%

33019010

Extracted oleoresins

3.80%

 

3.80%

33019050

Concentrates of essential oils

0.00%

 

0.00%

330290

Mixture of odiferous substances NESOI

0.00%

 

0.00%

400130

Gutta-percha

0.00%

 

0.00%

SOURCES: International Trade Centre (ITC) UNCTAD/WTO. Market Access Map cross-referenced for accuracy against the Harmonized Tariff Schedule of the Unites States (2007) (Rev.1).


References

  1. Food and Drug Administration. 21 CFR Part 111: Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. Final Rule. Federal Register. 25 June 2007;21(121): 34751-34958. Available at: http://www.cfsan.fda.gov/~lrd/fr07625a.html.
  2. Food and Drug Administration. Testing and approval or rejection of components, drug product containers, and closures. In. Code of Federal Regulations, Title 21, Volume 4, Chapter I, Part 211, Subpart E, Section §211.84. Washington, DC: U.S. Government Printing Office via GPO Access. 1 April 2007;140-141. Available at: http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.gpo.gov/cfr_2007/aprqtr/pdf/21cfr211.84.pdf
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