How to sell Herbs/ Dietary Supplements on Amazon
This is next to impossible. Best option is to find a company to send your herbs to for processing and packaging to do this. Otherwise, you can be an herbalist and recommend herbs you grow, tinctures, ointments, etc to “patients”. Thanks to the 1994 laws that Clinton put in place, this is primarily a production that is $100’s to start up on your own if you want to go thru Amazon. You can do phone & webcam consults and have a website and do this that was as an herbalist, if this is the way you want to go.
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Dietary supplements are vitamins, minerals, herbs, or other substances (like amino acids or fatty acids) eaten to supplement the diet. They often come in forms like tablets, capsules, softgels, gelcaps, powders, and liquids.
Supplements must be correctly described and labeled, and they must not be prohibited by Amazon policies. Please use the checklist below to be sure your product can be sold on Amazon.
- Supplements must be sealed in the original manufacturer’s packaging
- Supplements must be new and unused
- Supplements must clearly display the identifying codes placed on the packaging by the manufacturer or distributor, such as matrix codes, lot numbers, or serial numbers
- Supplements must be labeled in English with the following information:
- The name of the dietary supplement
- The total quantity or amount of the dietary supplement (e.g. 100 tablets, 5 mg, 6 oz)
- A “Supplement Facts” panel
- The ingredient list
- The name and address of the manufacturer, packer, or distributor
- Supplement labels must not state that the products cure, mitigate, treat, or prevent a disease in humans, unless that statement is approved by the FDA
- Supplement labels must not claim that the products have the same effects as controlled substances or prescription drugs (e.g. supplements cannot have names that could be confused with controlled substances or prescriptions drugs, like “Viagrex” or “TestosterX”)
- Supplement labels must not claim that the supplements are “FDA approved”
- Supplement labels must not use the FDA logo
- Supplement labels must not state “tester,” “not for retail sale,” or “not intended for resale”
- Detail pages must include the following information:
- The name of the dietary supplement
- The ingredient list, including an image of the ingredient list from the product label
- Detail pages must not state that the products cure, mitigate, treat, or prevent a disease in humans, unless that statement is approved by the FDA
- Detail pages must not include disease names in the keywords
- Detail pages must not state that the products have the same effects as controlled substances or prescription drugs (e.g. supplements cannot state that they are alternatives to prescription drugs or that they are just as effective as a prescription drug)
- Detail pages must not claim that the products produce an effect similar to that of an anabolic steroid, such as “Legal Steroids”
- Detail pages must not state that the supplements are “FDA approved”
- Images associated with detail pages must not include the FDA logo
Products and ingredients
- Supplements must not be named in an FDA recall or safety alert (for more information, see: Recalls, Market Withdrawals, & Safety Alerts)
- Supplements must not contain ingredients prohibited by the FDA (for more information, see: Dietary Supplement Products & Ingredients)
- Supplements must not be identified as adulterated (e.g. unsafe or lacking evidence of safety) or misbranded (e.g. having false or misleading information on the label) in an FDA warning letter (for more information, see: FDA Warning Letters)
- Supplements must be safe for use and must not be a product that the FDA has determined presents an unreasonable risk of injury or illness, such as:
- Products that contain pure powdered caffeine (for more information, see: Pure and Highly Concentrated Caffeine)
- Supplements must not be named by the Federal Trade Commission (FTC) as making untrue marketing claims (for more information, see: Federal Trade Commission Press Releases)
- Supplements must not contain controlled substances, such as:
- Cannabidiol (CBD), a Schedule I Controlled Substance (for more information, see: Restricted Products: Drugs & Drug Paraphernalia)
- Anything listed in Schedules I, II, III, IV or V of the Controlled Substances Act (for more information, see: Schedules of Controlled Substances)
- “List I” chemicals or their derivatives as designated by the Drug Enforcement Administration (DEA) (for more information, see: List I and List II Chemicals)
- Supplements must comply with Amazon policies, including:
- Supplements that contain ingredients derived from sharks, whales, dolphins, or porpoises are prohibited from sale
- Supplements that contain more than 12% hydrogen peroxide are prohibited from sale
- Patches that are marketed as dietary supplements or detox products are prohibited from sale
- Male enhancement supplements with the brand name Rhino are prohibited from sale
Additional Useful Resources
- LegitScript has a searchable database that may help when determining if a supplement includes a prohibited ingredient: https://www.legitscript.com/
- The U.S. Anti-Doping Agency has a list of high-risk supplements that may help when determining if a supplement includes a prohibited ingredient: https://www.usada.org/substances/supplement-411/
Related Amazon Help Pages
- Restricted Products: Animals & Animal Products
- Restricted Products: Cosmetics
- Restricted Products: Food & Beverage
- Restricted Products: Drugs & Drug Paraphernalia
- Restricted Products: Medical Devices & Accessories
Is there any licensing for herbalists in the United States?
The licensing of medical and many health practices (e.g. massage therapists) occurs on a state level. There is currently no licensing or certification for herbalists in any state that precludes the rights of anyone to use, dispense, or recommend herbs. However, in a small number of states such as California, Naturopathic (ND) and acupuncturist licensing laws (LAc) include clauses that define natural remedies and sometimes specifically herbal remedies within the scope of the licensed practice. There is currently no state-level licensing for herbalists other than those linked to an acupuncture license (LAc). However, no current license precludes the right of other health professionals or lay persons to use, dispense, or recommend herbs, and additional legal protections granted to the license holder specifically related to the use of herbs are not always clear.
Besides the AHG’s Registered Herbalist, non-licensed credentials include the Diplomate in Chinese Herbology offered by the National Certification Commission of Acupuncture and Oriental Medicine (NCCAOM).
AHG Registered Herbalist is a voluntary, peer-reviewed credential that allows the practitioner to refer to him/herself as a Registered Herbalist (RH).
The AHG does not support the imposition of licensing for herbalists. The AHG mission statement as revised and adopted in 2013 includes the promotion of “freedom of practice”.
What laws protect my rights as an herbalist?
In the absence of licensing, the First Amendment of the Constitution protects our freedom of speech to provide information to clients related to their health. However, this is restricted by the necessity to avoid practicing medicine without a license.
Medical practice is regulated on the state level, and herbalists should familiarize themselves with the language of the statutes in the state in which they practice. Generally speaking, only physicians (and in some cases some others such as nurse practitioners) can legally diagnose, prescribe, treat, or cure disease.
Herbalists (who are not also MDs) should be clear and transparent with all clients and the public about this; the AHG advises all practitioners to utilize an Informed Consent and Disclosure form that makes this clear. (You can find templates of such forms in the AHG Mentorship Handbook, available here).
To avoid practicing medicine without a license, herbalists should familiarize themselves well with this language, and bear in mind that it applies to all communications: verbal communication to the public and clients, written recommendations, brochures or other literature, and website language.
In addition, if you provide herbs to your clients, and use language that can be construed as diagnosing, preventing, treating, or curing disease, you may also be violating FDA and FTC regulations regarding product claims, since in that context the herbal remedy can be considered an unapproved drug.
There are ongoing efforts to loosen some of these legal restrictions on herbalists and other alternative/holistic practitioners, some with varying degrees of limited success, generally under the rubric of Health Freedom. These are state-based initiatives. For more information you can go to: http://nationalhealthfreedom.org/info-center/health-freedom-laws-passed/…
(The AHG cannot independently confirm the accuracy of all the information found here.)
As a small-scale pharmacy or herb shop you may have further restrictions. Depending on the nature of your business you may have to comply with Good Manufacturing Practices of the FDA (see below). Labeling and advertising would come under FDA and FTC regulations and would have to comply with language guidelines (see below for more information). In some states there are state laws restricting certain words from being used in the name of the business, such as “apothecary”, “pharmacy”, “medicine shop”, etc. It is incumbent on you to educate yourself about state laws wherever you are practicing or running a business.
Bear in mind that there are many ethical practices that are not necessarily legally required but highly recommended. Refer to the AHG Ethics policy as one resource.
If I teach a workshop or lead an herb walk, am I under the same restrictions as when I see a client?
No. If you are providing information purely in an educational setting – meaning there is no association whatsoever with a product, product line, or brand, and does not in any way involve giving any individual(s) health advice – then you are mainly free to discuss the therapeutic and historical uses of herbs. This would include leading an herb walk, teaching a class, or writing an article or book. But bear in mind that these lines can get blurry quickly – a discussion in a workshop can turn into providing health recommendations; an in-class intake could potentially be considered a clinical, not an educational setting. And of course the First Amendment has its limitations – we are always ethically accountable as well as potentially legally liable for what we say or write.
Product and Manufacturing Related Questions
What is DSHEA?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the main piece of legislation regulating the manufacture of dietary supplements, including herbs. DSHEA established the new category of dietary supplement, a subcategory of food but in some respects falling between the categories of food and drug.
The legal definition of dietary supplement according to DSHEA includes “vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”
Although there are many DSHEA-related challenges for the herbal community, the restrictions it has imposed on the FDA have also protected public freedom of access to herbs to a stronger degree than in some other industrialized nations.
What are the Good Manufacturing Practices (GMPs)?
The Dietary Supplement GMPS or cGMPs (current Good Manufacturing Practices) are now in force for all manufacturers. Prior to this, herbal manufacturers complied with food GMPs, which are less stringent. GMPs address all aspects of the manufacturing process, including: positive identification and assurance of purity (for whole herbs organoleptic and macro-identification may be sufficient; for powders and extracts it is necessary to utilize tools such as microscopy, thin layer chromatography, and/or high pressure liquid chromatography); tracking of source materials; comprehensive documentation; training of personnel, and hygiene.
It is highly advisable to consider being trained in the GMPs appropriate to your scale of business. It is a highly complex set of regulations and these FAQs are intended solely as a broad overview and introduction to the topic. See below for more resources.
Is there an exemption from the GMPs for small businesses?
No there is not. Whether you are a business with 100 employees, or making tinctures in your kitchen and selling them at the local farmers’ market, legally you are a manufacturer and the GMPs apply to you. (See below for more information on individual herbalists selling herbs only to clients).
I purchase extracts from established manufacturers that I believe are GMP-compliant. All I do is compound them into formulas and re-label them for sale to the public. Am I exempt from the GMPs?
No. If you open the packaging or change the label, you are now considered a manufacturer and the GMPs apply to you.
I make or compound formulas for my clients but do not sell to the general public. Am I exempt from the GMPs?
There is no exemption from the GMPs for the individual herbalist. However, the FDA has decided to use its discretion to not focus on individual practitioners who sell supplements to clients as part of an individualized consultation. Theoretically the FDA could decide at any time to modify this practice.
It is advisable for individual herbalists in this situation to familiarize themselves with the GMPs and implement some of the most important best practices such as methods for positive identification of ingredients, tracking of source materials, and proper documentation.
I work in a student clinic at an herb school. Are we considered a manufacturer required to comply with the GMPs?
This is somewhat of a grey area but for now the FDA appears to be considering this category in a similar fashion to the individual herbalist. It is advisable for schools to initiate some of the most important best practices and begin to position themselves to gradually implement the GMPs more fully.
I grow and/or gather herbs and sell them fresh or dried, in a whole, unprocessed form, such as teas or tea blends, with no label claims regarding their use. Do I need to comply with the GMPs?
For herbal teas labeling, marketing, and intended use dictates the regulatory category. For a tea to be considered a general food it can make no claims to affect the human body. In that case food-related GMPs and/or other regulations may apply (such as local or state health or agriculture departments, or USDA), but not the Dietary Supplement GMPs.
For more guidance, according to the AHPA guidance document: “Dried unprocessed herb” means an herb or other botanical that is dehydrated from its fresh state and that has not been subjected to any further processing other than cleaning, grading, or size reduction (e.g., cutting or powdering).
Similarly, products intended only for topical use may fall under regulations for cosmetics, which are less stringent than those for dietary supplements.
What am I required to put on the labels of the herbal remedies I make?
Requirements for labels include: statement of identity, net quantity of contents, directions for use, other ingredients in descending order of predominance and by common name or proprietary blend, and a Supplement Facts panel.
Manufacturers are also now required to put contact information on their labels and must report all serious adverse effects (whether causation has been determined or not), defined as “death; a life-threatening experience; inpatient hospitalization; significant or persistent disability; congenital anomaly or birth defect, or requires, based on reasonable medical judgment, medical or surgical intervention to prevent above”.
A dietary supplement manufacturer wishing to make a claim for the product must ensure that it falls strictly under the definition of a structure/function claim. If a claim is made or implied that the product can cure, mitigate, treat or prevent disease the FDA can consider this to be an unapproved drug claim. Bear in mind that this applies to not only the product label itself but also any associated literature, brochures or catalogs, website information (potentially even links on the website), and verbal communications in product-related presentations or trainings. The Federal Trade Commission (FTC) also has jurisdiction over some of these areas, in addition to the FDA.
If a structure/function claim is made the following disclaimer must also be present:
“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Prior to making structure/function claims you must possess substantiated evidence supporting that the claim is truthful and not misleading. “Appropriate evidence” has not been defined by FDA; however a guidance document has been issued. Generally FDA would like to see randomized, placebo controlled studies. In the event these studies are pre-clinical (animal) they also require an explanation for why a similar reaction might be expected in humans. Manufacturers are expected to submit pre-market notification of any claims made for dietary supplements. This notification also includes a statement that the manufacturer can substantiate the claim. The pre-market notification has been a requirement since DSHEA was passed, but has only begun to be enforced within the last year.
Traditional use claims are not recognized by FDA. Generally FDA would consider traditional use claims to be drug claims. In contrast the FTC has stated that it will not pursue fines for traditional use claims that do not address serious health conditions, and are not false or misleading. However, the FTC also states that FDA may choose to pursue enforcement action, regardless of the FTC’s stance.
Names of products do not have to be submitted to the FDA, but the FDA has the authority to consider a name to be a drug claim if it implies the treatment of a disease. The FTC can also consider the name of a product to be false advertising and may require “proof” of claim.
Claims-related violations are one of the more common categories of FDA citations of manufacturers.
What else am I required to do as a manufacturer of any size?
There is a general requirement for site registration: All manufacturers, regardless of scale, must register their site with FDA. Site registration can be completed on the FDA website. An unregistered manufacturer will be ordered to cease manufacturing until registration has been completed. FDA also reserves the right to take legal action.
There are other regulations you may need to comply with such as paying a tax on ethyl alcohol if used in your business, unless you have thoroughly investigated how to be legally exempt. State laws regarding ethyl alcohol vary.
You must also educate yourself about the use of other terms or labels, such as organic that are outside the scope of this FAQ page.
For more information on organic
And/or contact your local or state organic certification agency.
Other useful links:
FDA cGMP for Dietary Supplements Small Entity Compliance Guide
FDA cGMP Clearinghouse of Info Page
FDA Labeling Guide
FDA Small Entity Guide to Structure Function Claims
American Herbal Pharmacopoeia
American Herbal Products Association
American Botanical Council
Roger Wicke website discussion of herbal practice
Coverage of the DS CGMP Rule
- Who is subject to the DS CGMP rule?You are subject to the DS CGMP rule if you manufacture, package, label, or hold a dietary supplement.
- Am I subject to the DS CGMP rule if my product is sold only within my state?You may be subject to the DS CGMP rule for products sold only within your state. FDA may consider its jurisdiction over such products under the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, or both, depending on the circumstances of the situation.(72 FR 34752 at 34785)
- Am I subject to the holding requirements established in the DS CGMP rule if I am a retailer who is holding dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers?No. Importantly, a retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.
- Am I subject to the DS CGMP rule if I am a practitioner (such as an herbalist, acupuncturist, naturopath, or other related health care provider)?Yes. Practitioners such as herbalists, acupuncturists, naturopaths, and other related health care providers are subject to the DS CGMP rule. However, we believe that it would be appropriate to consider the exercise of our enforcement discretion in certain circumstances (see example which follows in the next question).(72 FR 34752 at 34793)
- How does FDA expect to apply the DS CGMP rule to practitioners?FDA expects to exercise enforcement discretion, on a case-by-case basis, in determining whether to apply the DS CGMP rule to practitioners such as herbalists, acupuncturists, naturopaths, and other related health care providers. For example:
- We expect to exercise discretion in the case of a one-on-one consultation by a practitioner who is adequately trained in his or her profession. We believe such a case may not necessitate the same types of controls as we established in the DS CGMP rule for manufacturing activities on a larger scale. Such a practitioner may make some formulations in advance of the consultation and still make the formulations in very limited quantities for the individual client.
- We are not considering exercising our enforcement discretion with respect to practitioners who prepare batches of dietary supplements and sell them to individual consumers without determining whether the dietary supplement is appropriate for each consumer’s needs in a one-on-one personal consultation.
- We are not considering exercising our enforcement discretion with respect to practitioners who prepare batches of a dietary supplement for which there is a known or suspected safety concern.
- Do other statutory provisions and regulations apply to persons who manufacture, package, label or hold dietary supplements?Yes. You must comply with other applicable statutory provisions and regulations under the Federal Food, Drug, and Cosmetic Act related to dietary supplements.(21 CFR 111.5)
- How does the DS CGMP rule relate to the food CGMP rule in 21 CFR part 110?In establishing 21 CFR part 111, we:
- Duplicated those requirements in the food CGMP rule (i.e., 21 CFR part 110) that we found to be common to most dietary supplements;
- Did not duplicate those requirements in the food CGMP rule that were not common to most dietary supplements.
- Does the DS CGMP rule require me to establish and follow written procedures?Yes. The DS CGMP rule requires you to establish and follow the written procedures shown in Table 3.
- Does the DS CGMP rule require me to establish and follow written procedures for product recalls? No. However, we encourage you to refer to our “Guidance for Industry: Product Recalls, Including Removals and Corrections” (Ref. 1) (72 FR 34752 at 34774).
- What hygienic practices does the DS CGMP rule identify for me to use to protect against contamination of components, dietary supplements, or contact surfaces? Below, we list the specific hygienic practices identified in the DS CGMP rule. You should refer to 21 CFR 111.10(b) for the complete description associated with each of the items in the list.
- Wearing outer garments;
- Maintaining adequate personal cleanliness;
- Washing and sanitizing hands;
- Removing unsecured jewelry (and other unsecured objects);
- Using gloves made of an impermeable material and maintaining them in an intact, clean and sanitary condition;
- Wearing effective hair restraints;
- Not storing clothing or other personal belongings in areas where components, dietary supplements, or any contact surfaces are exposed or where contact surfaces are washed;
- Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed; and
- Taking any other precautions necessary to protect against the contamination of components, dietary supplements, or contact surfaces with microorganisms, filth, or any other extraneous materials.
- What does the DS CGMP rule require regarding personnel?The DS CGMP rule requires that:
- You have qualified employees who manufacture, package, label, or hold dietary supplements (21 CFR 111.12(a));
- You identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and such responsibilities must be distinct and separate from other responsibilities (21 CFR 111.12(b)); and
- Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, to have the education, training, or experience to perform the person’s assigned functions (21 CFR 111.12(c)).
- What does the DS CGMP rule require regarding the physical plant and grounds?The DS CGMP rule:
- Requires you to keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces, and establishes several specific measures for you to take to do this (21 CFR 111.15(a));
- Requires you to maintain your physical plant in a clean and sanitary condition, and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated (21 CFR 111.15(b)); and
- Establishes specific requirements for:
- Cleaning compounds, sanitizing agents, pesticides, and other toxic materials (21 CFR 111.15(c));
- Pest control (21 CFR 111.15(d));
- Plumbing and sewage (21 CFR 111.15(f) and (g));
- Bathrooms and hand washing facilities (21 CFR 111.15(h) and (i));
- Trash disposal (21 CFR 111.15(j));
- Sanitation supervisors (21 CFR 111.15)(k));
- The design and construction of the physical plant (21 CFR 111.20); and
- The water supply (see 21 CFR 111.15(e) and Questions 2 through 7 in section VIII of this document).
- What does the DS CGMP rule require regarding the water supply when the water does not become a component of a dietary supplement?The DS CGMP rule requires you to provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement.(21 CFR 111.15(e)(1))
- What kinds of equipment and utensils are covered by the DS CGMP rule?Equipment and utensils used in manufacturing, packaging, labeling or holding operations that are covered by the DS CGMP rule include:
- Equipment used to hold or convey;
- Equipment used to measure;
- Equipment using compressed air or gas;
- Equipment used to carry out processes in closed pipes and vessels; and
- Equipment used in automated, mechanical, or electronic systems
- What requirements does the DS CGMP rule establish regarding equipment and utensils?The DS CGMP rule establishes requirements for:
- The design, construction, installation, use and maintenance of equipment and utensils, including specific requirements for the seams of equipment and utensils, cold storage compartments, instruments or controls used to measure or record, and compressed air or other gases (21 CFR 111.27(a)); and
- Calibrating equipment and controls (21 CFR 111.27(b)).
- What does the DS CGMP rule require regarding automated, mechanical, or electronic equipment that you use to manufacture, package, label or hold a dietary supplement?For any automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, the DS CGMP rule requires you to:
- Design or select equipment to ensure that dietary supplement specifications are consistently met (21 CFR 111.30(a));
- Determine the suitability of the equipment by ensuring that your equipment is capable of operating satisfactorily within the operating limits required by the process (21 CFR 111.30(b));
- Routinely calibrate, inspect, or check the equipment to ensure proper performance. Your quality control personnel must periodically review these calibrations, inspections, or checks (21 CFR 111.30(c));
- Establish and use appropriate controls for automated, mechanical, and electronic equipment (including software for a computer controlled process) to ensure that any changes to the manufacturing, packaging, labeling, holding, or other operations are approved by quality control personnel and instituted only by authorized personnel (21 CFR 111.30(d)); and
- Establish and use appropriate controls to ensure that the equipment functions in accordance with its i ntended use. These controls must be approved by quality control personnel (21 CFR 111.30(e)).
- What specifications does the DS CGMP rule require me to establish?The DS CGMP rule requires you to establish:
- A specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.70(a));
- Specifications for components you use in the manufacture of a dietary supplement (21 CFR 111.70(b));
- Specifications for the in-process production (21 CFR 111.70(c));
- Specifications for dietary supplement labels and packaging (21 CFR 111.70(d));
- Product specifications for the finished batch of the dietary supplement (21 CFR 111.70(e));
- Specifications for product you receive from a supplier for packaging or labeling as a dietary supplement (21 CFR 111.70(f)); and
- Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements (21 CFR 111.70g)).
- Should I have data to support any expiration date (or “shelf date” or “best if used by” date) that I will place on a product label?Yes. Although the DS CGMP rule does not require you to establish an “expiration date” (or a “shelf date” or “best if used by” date), you should have data to support any such date that you place on a product label.(72 FR 34752 at 34855)
- What does the DS CGMP rule require regarding the tests and examinations I use to determine whether specifications are met?The DS CGMP rule requires that:
- You ensure that the tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods (21 CFR 111.75(h)(1)); and
- The tests and examinations you use include at least one of the following (21 CFR 111.75(h)(2)):
- Gross organoleptic analysis (21 CFR 111.75(h)(2)(i));
- Macroscopic analysis (21 CFR 111.75(h)(2)(ii));
- Microscopic analysis (21 CFR 111.75(h)(2)(iii));
- Chemical analysis (21 CFR 111.75(h)(2)(iv)); or
- Other scientifically valid methods (21 CFR 111.75(h)(2)(v)).
- Does the DS CGMP rule require any verification that a finished batch of dietary supplement meets product specifications?Yes. The DS CGMP rule requires you to verify that a subset of finished dietary supplement batches (which you identify through a sound statistical sampling plan) meets product specifications (i.e., specifications that the DS CGMP rule requires you to establish under 21 CFR 111.70(e)), unless you choose to verify that product specifications are met for every finished batch (21 CFR 111.75(c)). To do so, the DS CGMP rule requires that:
- You select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if determined to be in compliance with specifications by testing or examination of the finished batch of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications (with the exception of those product specifications that are exempted from this requirement) (21 CFR 111.75(c)(1) and 21 CFR 111.75(d));
- You conduct appropriate tests or examinations to determine compliance with these specifications (21 CFR 111.75(c)(2));
- You provide adequate documentation of your basis for determining that compliance with the selected specification(s), through the use of appropriate tests or examinations, will ensure that your finished batch of the dietary supplement meets all product specifications established under 21 CFR 111.70(e) (21 CFR111.75(c)(3)); and
- Your quality control personnel review and approve this documentation (21 CFR 111.75(c)(4)).
- Is there any exemption from the requirement of the DS CGMP rule regarding verification that a finished batch of dietary supplement meets product specifications?Yes (21 CFR 111.75(d)). We realize that there may well be some specifications that you may not be able to test for at the finished batch stage. For example, you may determine that you could not verify, by testing for compliance with the specifications for identity and composition, that the purity specification is met, and there may be no scientifically valid method for testing or examining the finished batch to evaluate the purity in the finished batch of dietary supplement. In such a case, the DS CGMP rule provides that you can document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that this product specification is met without verification through periodic testing of the finished batch, provided your quality control personnel review and approve that documentation (21 CFR 111.75(d)). For example, you could exempt the specification for purity from the requirement in 21 CFR 111.75(c)(1) through, for example, documentation that meeting component and specifications for strength is sufficient, or through documentation that in-process monitoring is sufficient, provided your quality control personnel review and approve such documentation (21 CFR 111.75(d)).(72 FR 34752 at 34850)
- What does the CGMP rule require me to do if I rely on a Certificate of Analysis from a supplier to confirm the identity of a component other than a dietary ingredient, or to determine whether any other component specifications are met?The DS CGMP rule requires that:
- 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 (21 CFR 111.75(a)(2)(ii)(A)).
- The certificate of analysis include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations (21 CFR 111.75(a)(2)(ii)(B)).
- You maintain documentation of how you qualified the supplier (21 CFR 111.75(a)(2)(ii)(C)).
- You periodically re-confirm the supplier’s certificate of analysis (21 CFR 111.75(a)(2)(ii)(D)).
- Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier (21 CFR 111.75(a)(2)(ii)(E)).
- Requirements for Representative and Reserve Samples
- What representative samples does the DS CGMP rule require me to collect?The DS CGMP rule requires you to collect representative samples of the following materials:
- Each unique lot of components, packaging, and labels that you use (21 CFR 111.80(a));
- In-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master manufacturing record where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements (21 CFR 111.80(b));
- A subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution (21 CFR 111.80(c));
- Each unique shipment, and each unique lot within each unique shipment, of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier (21 CFR 111.80(d)); and
- Each lot of packaged and labeled dietary supplements (21 CFR 111.80(e)).
- Why does the DS CGMP rule require me to collect and to hold representative samples?The DS CGMP rule requires you to collect representative samples to determine whether applicable specifications are met.(21 CFR 111.80)
- What reserve samples does the DS CGMP rule require me to collect and hold?The DS CGMP rule requires you to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute. This would include dietary supplements that you package and label in bulk.(21 CFR 111.83(a))
- Why does the DS CGMP rule require me to collect and to hold reserve samples of packaged and labeled dietary supplements?The DS CGMP rule requires you to collect and hold reserve samples of packaged and labeled dietary supplements for use in appropriate investigations, such as consumer complaint investigations.(21 CFR 111.83(b)(3) and 21 CFR 111.465(b))
- How many reserve samples does the DS CGMP rule require me to collect and hold?The DS CGMP rule requires that the amount of reserve samples you collect and hold consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.(21 CFR 111.83(b)(4))
- How does the DS CGMP rule require me to identify reserve samples of packaged and labeled dietary supplements?The DS CGMP rule requires you to identify reserve samples with the batch, lot, or control number.(21 CFR 111.83(b)(2))
- What container-closure system does the DS CGMP rule require me to use to hold reserve samples of packaged and labeled dietary supplements?The DS CGMP rule requires you to use the following container-closure systems to hold reserve samples of dietary supplements:
- If you are distributing a packaged and labeled dietary supplement, the DS CGMP rule requires you to keep the reserve samples in a container-closure system that is the same as the container-closure system in which the dietary supplement is distributed.
- If you are distributing a dietary supplement for packaging and labeling, the DS CGMP rule requires you to keep the reserve samples in a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which you distributed the dietary supplement for packaging and labeling elsewhere. For example, if you distribute product in bulk using a polyethylene bottle that can hold 50 kilograms of the product, and there is an air space above the product, you would hold the reserve samples in a polyethylene bottle with an air space. However, you would use a bottle sized to fit the smaller amount you are holding in reserve.
- How long does the DS CGMP rule require me to hold reserve samples of packaged and labeled dietary supplements?The DS CGMP rule requires you to hold reserve samples of packaged and labeled dietary supplements for:
- One year past the shelf life date (if shelf life dating is used); or
- Two years from the date of distribution of the last batch of dietary supplements associated with the reserve sample.(21 CFR 111.83(b)(3); 72 FR 34752 at 34905)
- What representative samples does the DS CGMP rule require me to collect?The DS CGMP rule requires you to collect representative samples of the following materials: