|Footnotes for this article are available at the end of this page.
In a move that some in the natural product space have been asking for, Amazon has begun the process of implementing new requirements for selling dietary supplements on its online platform.1 Amazon’s new requirements, which are required for each separate dietary supplement listed on Amazon, can be found here, and include:
- A Certificate of Analysis (CoA), from an ISO/IEC 17025 accredited laboratory. Each CoA must have been issued within the previous six months, be for product that is within its expiration date, and include:
- the product’s name;
- batch, lot number, or date code of the product;
- name and address of the manufacturer or distributor;
- the name of each ingredient noted on the Supplement Facts Panel (SFP) along with quantitative analysis confirming that the product contains the amount of ingredients as noted in the SPF; and
- the units of measure on the CoA must be the same units of measure as found in the SFP.
- Product images that must show all sides of the product label that include:
- the name of the product;
- the name and address of the company;
- batch, lot number, or date code of the product; and
- the SFP.
- A letter of guarantee from the manufacturer, on their letterhead, that:
- includes the complete name of the product as it is represented in the product label and labeling;
- an assurance that the product has been properly manufactured under the Good Manufacturing Practices of 21 C.F.R. 111;
- assurance that the product is not adulterated under Section 402(f) of the Federal Food, Drug, and Cosmetic Act;
- assurance that the amount of ingredients in the product reflects what is represented in the SFP and is safe for consumption.
Indications are that Amazon will require full compliance with the new requirements for all dietary supplements sold on its platform by February 2021. If Amazon determines that any of the requirements are not met, once they are fully implemented, their policy includes options to: remove the product from its site, suspend the seller from marketing products on Amazon, withhold payments to the seller, or even pursue legal action.
- The CoA requirements, as they currently are, focus only on confirming that products contain ingredients as represented on the product’s label. As of yet, Amazon has not established requirements to test products for known possible adulterants or contaminants.
- It is unclear if Amazon intends to confirm CoAs or even consider whether they contain the correct types of information. Evaluating the validity and thoroughness of a CoA can be complicated and time-consuming. It remains to be seen how sophisticated Amazon will be in doing so.
- The requirement that the CoAs be provided by an “ISO/IEC 17025 accredited laboratory” is a bit broad. The scope of a specific ISO accreditation can be very limited. Labs are often accredited for a limited number of tests. Amazon should be specific in requiring that the lab be accredited in the specific tests used in creating the CoA.
- Requiring manufacturers to assure products are lawful and under Section 402(f) of the Act will be a more complicated task than it seems at first instance. It does seem reasonable to expect dietary supplement manufacturers to be in a position to assure that dietary supplements they produce do not contain dangerous or harmful ingredients.2Dietary supplements are, however, also adulterated under Section 402(f) of the Act if they contain “a new dietary ingredient for which there is inadequate information to provide reasonable assurances that such an ingredient does not present a significant risk of illness or injury.”3 This could be a very difficult assurance for a manufacturer to provide. For example, it would seem unreasonable to expect that a manufacturer will always be in a position to assure that a product does not contain a New Dietary Ingredient (NDI) that has, or has not, satisfied the NDI Notification requirements.4 Manufacturers, at least under the Act, are not necessarily required to have this information. This information could be held by the entity that will distribute the final product or even by a third party, not directly involved in the manufacture or distribution of the product, but someone who has licensed the rights to a New Dietary Ingredient that has been acknowledged by the FDA. The basis for legally marketing a specific New Dietary Ingredient may be information that the entity that holds it does not want to openly share with other parties.
- Finally, by making these representations, supplement companies could expose themselves to a greater risk of litigation, including class action attorneys alleging the statements are false and misleading. There has recently been a plethora of such suits filed under the federal Lanham Act or state deceptive trade practices, alleging such things as the label misstates the amount of the ingredients in the bottle, the product is not “all-natural,” or the product contains detectible levels of lead or other heavy metals. We would expect class action plaintiffs to include in their complaints that the defendant companies made misrepresentations to consumers as well as Amazon. Anyone served with a complaint should consult with their counsel.
For questions, please contact Richard J. Oparil or Robert Durkin.
 See: Section 402(f)(1)(A) of the Act.
 See: Section 402(f)(1)(B) of the Act.
 See: Section 413 of the Act.