Dietary supplements can come under attack from a number of angles. Private plaintiffs may allege harm or fraud, self-regulating bodies such as The National Advertising Division (NAD) of the Council of Better Business Bureaus and the Electronic Retailing Self-Regulation Program (ERSP) may review scientific and technical claims, as well as product performance and superiority claims.
Dietary supplement products have come under greater scrutiny in the past few years. These products can face a number of challenges, including the permissibility of ingredients, and safety and efficacy. An effective tool to respond to these challenges is a proactively prepared substantiation package (i.e. a package that addresses the safety, efficacy, and ingredient permissibility). And when it comes to claims substantiation packages, a small upfront investment can go a long way in defending a dietary supplement company’s reputation and revenue stream.
Dietary supplements can come under attack from a number of angles. Private plaintiffs may allege harm or fraud, self-regulating bodies such as The National Advertising Division (NAD) of the Council of Better Business Bureaus and the Electronic Retailing Self-Regulation Program (ERSP) may review scientific and technical claims, as well as product performance and superiority claims. In addition, the Food and Drug Administration (FDA), Federal Trade Commission (FTC) and State Attorneys General may also scrutinize your products.
Dietary supplement companies can minimize their potential legal exposure by having a claims substantiation package for their products. These packages may satisfy the regulators if a product comes under attack, and may also help identify potential safety concerns, problematic marketing claims, or even identify novel claims for your products. Claims substantiation packages have also demonstrated their value for dietary supplement companies that were eventually acquired or were seeking investment from an equity partner. A solid claim substantiation package can solidify a company’s commitment to good product stewardship and compliance with current regulations.
The Dietary Supplement Health and Education Act (DSHEA) is the current regulatory framework for dietary supplements marketed in the U.S. (See here to view). While DSHEA may be an indicator or FDA’s future practices, it is not current legislation, and contains nonbinding recommendations. Nonetheless, DSHEA can serve as the background for which a substantiation claims package is constructed.
Below we describe the three major components to a claims substantiation package.
DIETARY INGREDIENT COMPLIANCE
In general, dietary supplements do not require FDA approval prior to marketing. However, in the case that an ingredient is considered a new dietary ingredient (NDI), the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors notify the FDA about these ingredients (a NDI is an ingredient that was not marketed in the U.S. in a dietary supplement before October 15, 1994). Importantly, the NDI notification must include the information the company used as the basis to conclude that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use. The term “new dietary ingredient” means a dietary ingredient that was not marketed in the U.S. in a dietary supplement before October 15, 1994.
A review of a supplement’s ingredients is the first step in determining whether the ingredients can be considered dietary ingredients, which according to the FDA: “A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.”
The next step is to determine if any of the ingredients may be considered a NDI (that is not marketed in the U.S. in a dietary supplement before October 15, 1994; not listed or affirmed as ‘generally recognized as safe’ (GRAS); whether or not the ingredient was chemically altered). If an ingredient is determined to be an NDI, the FDA must be notified at least 75 days before the dietary ingredient is marketed.
We have a multitude of dietary supplement companies identify problematic ingredients in their products, as well as substantiate compliance of ingredients.
The burden of responsibility is on a dietary supplement manufacturer/distributor for ensuring the safety of their products. The gold-standard safety data to support your product would include a safety study using the finished product, in a relevant human population using the product as recommended on the product’s label.
However, in the absence of data on the finished product, a thorough safety review can be conducted on each ingredient (or a combination of ingredients) by researching the existing scientific literature on that ingredient. It is important that the assessment be representative of the available scientific data, and takes into consideration the totality of the evidence, so that a final and realistic safety assessment can be made.
At a basic level, human studies are normally considered as providing the strongest safety evidence, but when these studies are limited, animal and in vitro studies can, in some cases, be relied upon.
Overall, safety assessments can potentially alert you in a proactive manner to potential safety issues, while they also arm you with data to defend your product if the assessment has not identified any blatant potential safety issues.
Like safety, the burden of responsibility is on a dietary supplement manufacturer/distributor for ensuring that dietary supplement marketing claims (implied and expressed claims and any representations) are substantiated by adequate evidence to show that they are not false or misleading. In general, a claim is considered an explicit or implicit statement that a product has a certain benefit, which also includes statements made in testimonials.
While a detailed discussion of the different types of marketing claims, they broadly fall into the following categories (see here for relevant FDA page):
– Structure/Function Claims
– Health Claims (including Qualified Health Claims)
– Nutrient Content Claims
– Comparative Claims
Overall, there is no definitive number of studies required to substantiate a marketing claim. However, it is critical that a company considers all meanings of their marketing claims, the quality of the evidence supporting the claims (taking into consideration the levels of ingredients, route of administration, length of study, dosing regimen, study population, etc.), and the totality of the evidence supporting the claims.
The takeaway message is that FDA and FTC standards require competent and reliable scientific evidence to ubstantiate all marketing claims used in advertising and structure/function claims used on labels.
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