This article was inspired by readers like you: cosmetic, dietary supplement and functional food retailers and manufacturers who had questions about disclaimers and disclosures on labels and ads. Disclaimer: This article does not cover cautions, warnings or allergen alerts. However, for all consumer products (and especially those claiming health benefits), federal regulations require that dangers and safety risks be disclosed. They also should be disclosed for product liability reasons.
Usually for dietary supplement regulatory compliance, we think of U.S. Food and Drug Administration law, specifically the Dietary Supplement Health and Education Act. The FDA primarily governs the formulation, ingredients, manufacture and labeling of foods and supplements, while advertisements are governed by a sister agency, the Federal Trade Commission. The two agencies have shared jurisdiction under a long-standing memorandum of understanding, and they work together to monitor dietary supplements. The FDA's regulation of labeling includes labels affixed to product containers, box labeling, package inserts, fliers distributed at the point of sale and promotional Web site content. The FTC has primary responsibility for claims in advertising, including print, TV and radio ads, infomercials, catalogs and other marketing materials—such as on the Internet.
In general, all disclaimers and disclosures must be "clear and conspicuous," that is, readable, understandable and prominent. A good rule of thumb is that the lettering of a disclaimer or disclosure be the same size as the type of the claim being disclaimed, qualified or clarified. Specifically, the FTC objects to disclaimers in tiny lettering, which it terms "microprint" or "mouse print." While a disclaimer may often be required to prevent a claim from being false or deceptive, there are some claims that cannot be legally "cured," even with a clear disclaimer. For example, if an ad for an herbal supplement includes unqualified claims that the product will treat diabetes (yet without good substantiation) and also includes the DSHEA disclaimer below, this message is contradictory; in cases like these, "the DSHEA disclaimer is not likely to negate the explicit disease claims made in the ad and will not cure the fact that the claims are not substantiated," according to the 1998 FTC booklet, Dietary Supplements: An Advertising Guide for Industry. (Also note that such an ad concerning diabetes will be used by the FDA to determine that this herbal supplement is actually a drug.)
Supplements. When people in the health food industry say the disclaimer, they primarily mean the disclaimer from section 6 of DSHEA, which must accompany all structure/function claims in dietary supplement labeling. The claims must be linked with an asterisk (or similar symbol) to the following disclaimer statement.
The disclaimer must be in bold type and in letters of at least 1/16 of an inch type size in height. Unless the disclaimer is directly adjacent to the s/f statement, it must be in a box.
The next logical question is whether this identical disclaimer must be or should be included in supplement ads. Must? No. DSHEA does not apply to advertising. However, the FTC has stated that sometimes (depending on the appearance and text of the ad) a disclaimer is desirable to prevent consumers from being misled into believing that the supplement in question has been subjected to the same premarket safety and efficacy testing and FDA approval as for a prescription drug.
The basic requirement for every material claim about a product is that "competent and reliable scientific evidence" is needed for support or substantiation, and that the claim must not be false, deceptive or misleading. Often to avoid a misleading, false or deceptive claim, a disclaimer of some sort is necessary. If only preliminary animal studies have been performed then, "Animal studies indicate that …" is an accurate qualifier to preface a claim of efficacy. Thus, sometimes the promotional claim itself includes or starts with clear qualifiers to show the limits of the available evidence, for instance, with traditional use support: "Although not clinically studied, the ____ plant has been used for centuries by Native Americans to promote energy and mental clarity."
Consumer testimonials. Testimonials and endorsements are imputed to the marketer, who often wonders: How can I best use a great quotation in my ad? Do I need a disclaimer with each testimonial, and what other kinds of disclosures are required in an ad? Anecdotal evidence of a health benefit or efficacy of a supplement product—based solely on the experience of individual consumers—is generally not sufficient to substantiate an ad claim. Indeed, the FTC considers the testimonial to be itself another claim, rather than support. (According to the FTC, "The plural of anecdote is not data.") Also, if other substantiation fails to show that an individual experience is typical, then an accurate disclaimer is necessary. For example, after the claim, "I melted off 20 pounds in two weeks," the vague "Results may vary" in fine print is not a sufficient disclaimer.
Adequate qualification would be a prominent disclaimer immediately adjacent to the quotation, in the same size print, reading "These results are not typical. Average weight loss achieved in a clinical study was five pounds in two weeks." Weight-loss claims deserve, and receive, special attention. The FTC, under its "Big Fat Lie" initiative, has flagged and prosecuted certain claims as "infeasible" (impossible under current science), such as permanent weight loss while "eating all the carbs you want." For weight-loss supplements, all claims should be followed by disclosure-type language clarifying that the supplement works in the context of "a sensible diet and moderate exercise."
Expert endorsements. For an advertisement with a statement from a spokesperson or endorser, the ad must disclose any "material connection" between the endorser and the advertiser—any personal relationship, financial stake or managerial position—for example, if the endorser also happens to be an officer of the company. For an expert, make sure that the endorsement is not misleading in any respect, that the expert's qualifications are relevant and appropriate for the claim being made, and that the expert has conducted adequate examination of the product and its effects and a review of the scientific literature. For example, "Dr. Flimsy" stating that "Glucosamine improves joint mobility and flexibility" is deceptive and misleading, implying an M.D. in the field, especially if: a) Dr. Flimsy is a dermatologist with no credentials or background in rheumatology, or if b) Ms. Flimsy is a doctor in the sense that she has a Ph.D. ... in Art History, or c) if Dr. Flimsy is the sister of the company president and that "material connection" is not clearly disclosed. Similarly, if the "consumer" in a consumer testimonial is also a distributor of that product for the marketer, then the distributor relationship must be disclosed.
TV ads. Commercials, and in particular infomercials, can generate specific problems and requirements. An infomercial may not appear to the consumer to be a scientific report in any false, deceptive or misleading way. If an infomercial is staged or styled as a documentary or a news report of a "scientific discovery," then the proper disclaimer would be "Paid Advertisement" prominently at the top of the screen, at the beginning and at reasonable intervals. Furthermore, the FTC itself recommends in "FTC Facts for Business: Big Print. Little Print. What's the Deal?" that "Television advertisers should not hide key information in: a fast-moving 'crawl'; superscripts or subscripts using small print sizes or a color that fades into the background; type that disappears from the screen too fast for consumers to read and comprehend; or the middle of a long statement that scrolls vertically on the screen within a short period of time."
Many TV stations have their own guidelines that closely parallel FTC regulations—and sometimes surpass them.
Susan Brienza practices in the area of regulatory compliance, specifically FDA (including DSHEA) and FTC law. Her e-mail address is email@example.com.
Natural Foods Merchandiser volume XXVII/number 7/p. 20, 22