Substantiating Claims

It can be a costly mistake if you don’t.

By Todd Harrison

While it is important to ensure that the form of a structure/function claim is not considered an impermissible drug claim, it is equally important that the claim be properly substantiated. Indeed, the FD&C Act, as amended by DSHEA, requires that manufacturers and distributors of dietary supplements retain substantiation for all statements of nutritional support used to promote their product. This does not mean that functional food products that are marketed as conventional food are not required to have substantiation. In­deed, failure to have proper substantiation for any claims appearing on the label and labeling of any food product will cause the product to be misbranded under § 403(a)(1) of the FD&C Act.
As to the level of substantiation needed to substantiate a structure/function claim, FDA has yet to speak on this subject. However, at a minimum, the manufacturer or distributor of the food or dietary supplement should have competent and reliable scientific evidence that confirms the truthfulness of the claim. For example, if a product is promoted for joint health but only contains 200 mg of glucosamine sulfate per daily dose, this claim would be considered misleading if the scientific studies suggest that you need a daily dose of between 1,000 and 1,500 mg of glucosamine sulfate.

How Much Support For A Claim Is Necessary?

With that said, the level of support necessary to substantiate a claim de­pends largely on the claim being made. In this regard, FDA has provided no guidance to industry on determining the level of substantiation necessary to adequately substantiate. However, the Federal Trade Commission (FTC) has provided industry with guidance on this issue. For instance, claims that expressly state the level of support (e.g., “ten studies show”) or suggest a certain level of support (e.g., “doctors agree”) must be supported by that level of evidence. More often than not, however, claims will not suggest that a certain level of support exists for a claim. In this situation, the level of scientific support necessary to substantiate a claim depends on the amount of research experts in the field would consider adequate to establish the claim’s truthfulness. Indeed, although the FTC states that the quality of a study matters more than the quantity of studies, it will be the unusual occasion that one or two relatively small clinical studies will be adequate to substantiate a broad health-related claim. For example, a claim for “helps maintain normal blood sugar levels” would likely require more than a couple of short term studies to substantiate an unqualified claim because the claim could be construed as an implied “diabetes control” claim requiring well-controlled, long term studies. This is true even though the claim should be considered a permissible structure/function claim by FDA.

The type of evidence used to substantiate a claim may vary. Generally, the FTC prefers well-controlled human studies. However, animal studies and in vitro studies may be used to support a claim if experts in the field would consider them suitable substitutes for human studies. Epidemiologic studies may be substituted for well-controlled human studies, especially when the study is supported by other scientific evidence such as an explanation of how the nutrient works in the body. As stated earlier, the studies used to support a claim must support the actual claim being made.

For example, there are several competent and reliable studies that suggest that St. John’s Wort may be useful in treating mild depression. However, as of yet, there is little evidence to support the conclusion that St. John’s Wort helps support “a healthy mental outlook” in individuals that do not suffer from mild depression. Thus, FTC may consider the research on St. John’s Wort as a treatment for mild depression as inadequate to support “healthy mental outlook” or “brighten up an otherwise blue day” claims because the central focus of the studies was the effectiveness of St John’s Wort in treating mild depression, and not as a means of promoting a healthy outlook on a particular day. Indeed, the latter claim may be deemed to be even more de­ceptive than a general healthy mental outlook claim be­cause, in most in­stances, St. John’s Wort does not immediately affect a subject’s mood. Ra­ther, it takes four to six weeks of continuous use before most people will see an effect.

Another issue that arises from time to time is the reliance on article abstracts to substantiate claims. Abstracts alone are probably in­sufficient to support a claim because they generally do not provide sufficient details about the study to determine whether the study is supportive of the claim, or whether the design or execution are adequate. Instead, abstracts should be used as a starting point in determining the relevance of a particular study.

The Importance Of Study Design And Results

“Competent and reliable scientific evidence” means that the research must be conducted in such a manner as to yield meaningful results. In other words, claims must be based on solid scientific research, rather than on personal opinions—even those of an expert in the field. In assessing the competency and reliability of research, the FTC will generally look at the design, implementation and results of the research. As a general rule, the FTC will consider the following in assessing the competency and reliability of research: Well-controlled studies with blinded subjects and researchers are likely to be given greater weight than non blinded studies; longer-term studies are better than short-term studies; the study’s result should be statistically significant; the nature and quality of the written report is important; studies appearing in reputable peer-reviewed scientific journals are looked upon with favor and studies that are not published in peer-review journals may be used to substantiate claims if they would be considered properly designed and controlled studies by experts in the field.

Scientific evidence should not be viewed in a vacuum. It is the FTC’s position that any claim must be evaluated in light of the totality of the scientific evidence available. In other words, it is unlikely that one positive study will be sufficient to support a claim if there are ten studies that suggest the opposite conclusion. Indeed, in this situation, qualified language appearing in the claim such as “a recent study suggests” would be unlikely to remove the misleading nature of the claim unless the opposing studies are also disclosed in an equally prominent manner. However, if the most recent study is of such a caliber that it would virtually dispel the conclusions of the opposing studies, disclosure of the opposing research might not be necessary.

The FDA and FTC would also likely consider a particular structure/function claim mis­­lead­ing if the product also contains high levels of “harmful” nutrients, such as saturated fats, even though it also contains nutrients that are helpful. For example, the claim “Nutrition Next Bar contains 400 mg of vitamin E for your heart health” would be misleading if the product also contained high levels of fat, saturated fat, sodium, and/or cholesterol. Indeed, FDA could consider the claim misleading unless the product contained less than three grams of fat, one gram of saturated fat and 20 g of cholesterol per reference amount customarily consumed for the food.

In the end, it is important for a company to ensure that all claims, label, labeling and advertising, are properly substantiated. Failure to do so could have significant ramifications for a company if the claim is ever challenged.

NW

Todd A. Harrison is a senior associate with the law firm Keller & Heckman, Washington D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on food and dietary supplement adulteration, labeling and advertising issues. He can be reached at Keller & Heckman, 1001 G. St. NW, Suite 500 W, Washington D.C. 20001; 202-434-4244; Fax: 202-434-4646; E-mail: THarrison@khlaw.com.