Lawyers representing dietary supplement product manufacturers are well-aware of the many modes of attack that can be launched against their clients’ products: class-actions alleging the inadequacy of the marketing claims, consumer fraud suits, challenges by attorney generals, FTC, FDA, and even self-regulating advertising bodies such as the National Advertising Division (NAD), and the Electronic Retailing Self-Regulation Program (ERSP).
Lawyers representing dietary supplement product manufacturers are well-aware of the many modes of attack that can be launched against their clients’ products: class-actions alleging the inadequacy of the marketing claims, consumer fraud suits, challenges by attorney generals, FTC, FDA, and even self-regulating advertising bodies such as the National Advertising Division (NAD), and the Electronic Retailing Self-Regulation Program (ERSP). In this post, we discuss the keys to developing a solid substantiation of dietary supplement marketing claims, based on the best available science.
Although dietary supplement manufacturers are not required to obtain FDA approval before marketing their products, they must ensure that there is competent and reliable evidence supporting their claims to avoid legal actions that allege fraudulent marketing activities.
The FDA oversees product labeling, while the FTC oversees advertising. However, overlap often occurs. For example, the FDA may cite a product’s advertising claims as evidence of intended use, and the FTC may evaluate whether marketing claims are appropriate for the product’s classification. Both agencies may deem a manufacturer’s marketing claims false, deceptive, misleading, or exaggerated. Following a regulatory challenge, a manufacturer may be forced to remove its product from the market.
While dietary supplements can attract scrutiny from regulators, they can also draw legal challenges from consumers. A consumer or consumer advocacy group may file a lawsuit claiming that the product fails to deliver the advertised benefits or that it poses a safety risk. From these actions, a manufacturer can face substantial fines and legal fees.
To avoid these legal and regulatory entanglements, it is imperative that dietary supplement makers substantiate marketing claims before distributing their products. Properly substantiating marketing claims offers an important layer of protection against these types of challenges. Importantly, there are a number of components to consider when substantiating a product, since products can come under attack by allegations that the product does not meet the requirements of the DSHEA statute, the product is not safe, or the product is making false marketing claims.
We provide below three steps to the most effective substantiation of dietary supplement claims.
1. Ensure Ingredients Are Permissible
If the ingredients in your client’s product’s were used in dietary supplements – or present in the food supply – before passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), they are considered to be grandfathered under DSHEA. If an ingredient was not in use before the legislation, it may be considered a new dietary ingredient (NDI) and would require FDA notification. An ingredient may also be considered NDI if it has been chemically altered (see here for some examples of chemical alterations). Dietary supplement manufacturers are responsible for determining whether a dietary ingredient is a NDI and whether any ingredient in their products have been chemically altered.
While the FDA does not provide an official list of grandfathered ingredients, several authoritative and credible dietary supplement trade organizations have published lists of dietary ingredients in use before passage of DSHEA on October 15, 1994. Examples include the Council for Responsible Nutrition (CRN) and the National Nutritional Food Association (NNFA).
A rigorous DSHEA analysis is a key component in understanding whether the dietary supplement product meets the requirements of the DSHEA statute.
2. Ensure Adequate Safety on the Product
DSHEA sets forth specific criteria for evaluating the safety of dietary supplement products and places the responsibility for assessing this information on manufacturers and distributors.
Ultimately, in order to market a dietary supplement product, it is essential that there is adequate information demonstrating the safety of the product as formulated. Therefore, A clinical study of the dietary supplement product itself would provide the strongest evidence of its safety.
Most of the time, however, a product’s safety is assessed using an evaluation of its individual ingredients. When reviewing an ingredient’s safety, it is critical to evaluate its effects at the maximum recommended daily serving level. The strongest supporting evidence tends to come from human clinical studies conducted in subjects representative of your consumer’s demographics. Long-term studies are preferable. Animal and in vitro studies can certainly bolster the safety profile of a product’s ingredients.
Scientists with experience and expertise in conducting safety assessments of dietary supplement products can quickly help determine potential areas of concern, or provide reassurance of the safety of the ingredients found in the dietary supplement, based on the available science.
3. Ensure Marketing Claims Are Permissible and Substantiated
The marketing claims made by a dietary supplement product must be based on competent and reliable scientific evidence. To ensure sure that your clients’ marketing claims are accurate and truthful, it is critical to gather the following types of scientific evidence:
· Controlled, double-blind human clinical studies adequately powered to detect differences between groups
· Studies published in peer-reviewed scientific journals
· Long-term studies vs. acute, depending on the intended use of your product
· Statistically and clinically significant results
By law, dietary supplement products may carry three types of claims: health claims (for example, qualified health claims approved by FDA), structure/function claims, and nutrient content claims. According to FDA, “Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product.” Generally, different requirements tend to apply to each type of claim, and these differences have been clearly outlined by the FDA (see here).
Taking a proactive approach to substantiating your client’s dietary supplement products with competent and reliable scientific evidence is your best defense against regulatory and legal challenges. For products that have come under attack and do not have prior substantiation, having a team of scientists, like those at ISS, that can quickly build a solid substantiation is your best weapon.
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