Dietary Supplement Claims Substantiations
A Dietary Supplement is intended to provide nutrients, such as vitamins, minerals, fatty acids or amino acids that are missing or are not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs. Dietary supplements are regulated as foods, not as drugs. While pharmaceutical companies are required to obtain FDA approval proving the safety or effectiveness of their products prior to their entry into the market, dietary supplements, like food, do not need to be pre-approved by FDA before they can enter the market.
The Federal Trade Commission standard of competent and reliable scientific evidence has been defined in FTC case law as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
In determining whether the substantiation standard has been met with competent and reliable scientific evidence, we recommend that firms consider the following issues in their assessment:
- The meaning of the claim(s) being made;
- The relationship of the evidence to the claim;
- The quality of the evidence; and
- The totality of the evidence.
The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have proof that the claim is truthful and not misleading.
To meet this statutory requirement, we recommend that manufacturers possess adequate substantiation for each reasonable interpretation of the claims. We intend to apply a standard that is consistent with the FTC standard of "competent and reliable scientific evidence" to substantiate a claim. We consider the following factors important to establish whether information would constitute "competent and reliable scientific evidence:"
- Does each study or piece of evidence bear a relationship to the specific claim(s)?
- What are the individual studies or evidence's strengths and weaknesses? Consider the type of study, the design of the study, analysis of the results, and peer review.
- If multiple studies exist, do the studies that have the most reliable methodologies suggest a particular outcome?
- If multiple studies exist, what do most studies suggest or find? Does the totality of the evidence agree with the claim(s)?
We have solutions for every type of client. If you are simply starting up or contemplating a new venture and would like to know the laws, regulations, expenses, timeframes and possible pitfalls, talk to us. If you are a multi-national firm that has completed this process hundreds of times before, we can help you as well. The ever-changing laws surrounding consumer goods such as Food, Dietary Supplements, Drugs and Cosmetics requires people that stay on top of all of the changes and proactively counsel with clients to ensure top profitability and lowest amount of downtime.
FDA Imports.com, LLC is a full-service regulatory consulting firm with consultants and affiliated attorneys with substantial experience in the field of dietary supplements. Let us show you “the way through” and show you how well the process can work when you have the right people backing up all decision-making.
