The FTC generally requires that statements about the efficacy or safety of dietary supplements be supported by “competent and reliable scientific evidence,” defined in FTC cases as “tests, analyses, research, studies, or other tests based on the experience of professionals in the relevant area,” that have been conducted. In an effort to dispel what the FTC calls “urban myths” about the substantiation needed to make health-related claims, the guide unequivocally states that the commission will strictly enforce the requirement that advertisers have “competent and reliable scientific evidence” for any health-related claim. Regardless of whether an announcement makes an express statement about the level of support (that is,. In evaluating the reliability of such tests, the FTC will consider several factors, such as sample size, duration, and outcome measures.
The guide also urges advertisers to consult with independent experts to assess whether a study was well designed and conducted, and if the data was properly analyzed. Only then can advertisers be able to say with confidence that their health claims are backed by competent and reliable scientific evidence. While the FTC does not require a specific number of reliable clinical studies, replication through one or more additional studies increases the burden that the commission will place on testing. However, the guide points out that “the quality of the research is more important than the quantity.
In addition, the guide warns that animal and in vitro studies cannot, on their own, substantiate health claims, nor can surveys on consumer experiences. In addition, the FTC will only accept epidemiological or observational studies when experts in the field consider them an acceptable substitute and clinical studies are not otherwise feasible (p. ex. The study should also yield statistically significant and clinically significant results (that is,.
In addition, the guide warns against post-hoc analysis of data, or “postal hacking”, and rejects it as a way of substantiating a statement in which the original protocol did not show significant results. In addition, the guide establishes a number of factors that the FTC will consider when analyzing the quality of the underlying evidence, factors that all advertisers and their research partners must consider when designing clinical trials to support them. Even when advertisers have valid internal studies to support their claims, they should consider all other research done in the field, including studies that show different results, to assess whether a claim is justified. In addition, advertisers must ensure that the research they rely on is actually relevant to the specific claim they make.
Many advertisements require the disclosure of qualified information to avoid deception. The guide reaffirms that these disclosures must be clear and striking, or “difficult to ignore”, and that ordinary customers can easily understand them. The guide also clarifies that disclosures must reflect any medium in which the announcement is published, so if the statement is made visually and audibly, the disclosure must also be made in both media. For statements made through social networks, the guide offers a new guide according to which the disclosure necessary to prevent deception must be “inevitable” and, he points out, “hyperlinks are avoidable”.
It should be noted that the guide contains new warnings to the effect that if, despite the disclosure, a “significant minority” of consumers withdraw a misleading statement, then the disclosure must be modified or the request must be suspended. Regardless of the above, the guide warns that advertisers cannot make traditional usage claims in relation to the treatment of serious medical conditions, which could put users at risk, even if they are carefully qualified. For example, the claim that a folk remedy is traditionally used to reduce the size of tumors is prohibited, regardless of clear revelations that there is no scientific support for such a statement. This is in line with the FDA's approach of considering these claims as converting such a product into a new drug not approved under the Federal Food, Drug and Cosmetic Act (FDCA), including the recent draft FDA guidance on homeopathic medicines.
The guide states that it will carefully analyze advertisements that use third-party literature, such as books, newspaper articles or summaries of scientific studies, to market its products, since such materials influence the way consumers interpret an advertisement. Advertisers will be responsible for any claims implied by reference to the materials. For example, if an advertisement for a dietary supplement contains a link to a book entitled “The Miracle Cure for Cancer”, which describes the purported healing properties of an herb that is also used in the dietary supplement, the seller is responsible for corroborating the implicit efficacy claims. Note that such cancer claims would make the product a new drug not approved under the FDCA and would exclude the product from the claims allowed for a dietary supplement, 2.The guide points out that the disclaimer required by the FDCA for dietary supplements, (that is,.
The guide also points out that advertisers should carefully avoid having their products or claims approved by the FDA. For example, when a Class I or Class II medical device has received FDA authorization, a label in an advertisement that says “FDA Approved” is misleading, as it exaggerates the FDA's review of the product, since it confuses the agency's “substantial equivalence determination” for low to moderate-risk devices with the more rigorous approval standard that the FDA applies to high-risk class III devices. Therefore, referring to the phrase “FDA Approved” for a device approved by the FDA 510 (k) route may falsely imply that the FDA has reviewed and approved any accompanying marketing claims. In short, while the guide provides parameters for meeting the FTC's strict requirements for health-related claims, advertisers should consider the separate FDCA requirements, which govern pre-marketing requests that are required before certain categories of products can be marketed, as well as the strict labeling requirements that vary by product category.
If you have any questions or concerns about FTC or FDA compliance, contact one of the lawyers listed below. The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products. LEXIS 182256 in *95-98 (“only human studies can confirm that a specific substance actually has an effect on humans and extrapolating data obtained from animal and in vitro studies to humans has significant limitations); FTC v. More concerning for manufacturers of dietary supplements is the FTC's suggestion that, in most cases, at least two randomized trials will be needed to substantiate a health-related claim of a dietary supplement.
Quattrone has extensive experience in advising clients on state and federal compliance issues and health care regulatory issues, and in responding to government subpoenas and civil investigation demands. The revised Guidelines make it clear that the FTC will continue to take an aggressive approach when analyzing advertising for dietary supplement products. Sellers of health-related products, including dietary supplements, should be familiar with the requirements of FDA and FTC law that labeling and advertising claims must be truthful, not misleading and justified. The document provides 52 examples, accompanied by several pages of endnotes with citations to previous FTC case law and agreements, to suggest activities and practices that could be under scrutiny by the FTC.
The revised guidance also reflects updates to other FTC guidance documents, including the guidance on supports and testimonials and the compliance policy statement on homeopathic medicines. The new guidance applies broadly to all health-related claims, not just those made about dietary supplements, and reflects the FTC cases and product innovations of the past two decades. While both the FTC and the FDA require that the marketing of dietary supplements and other health-related products be truthful and accurate, there are some key differences in legal frameworks and agency approaches that sellers should consider. It seems that, as with substantiation requirements, the FTC is trying to impose regulatory requirements on dietary supplements that are more appropriate for FDA-approved drugs intended to treat diseases.
It's a difficult task to expect lawyers working in the field of dietary supplements to be aware of the many results of the FTC litigation, much less the executives of companies in the dietary supplement industry, but that's what the FTC expects with the publication of the Guidelines. What's new, however, is that the FTC applies the Guidelines beyond dietary supplements to a variety of other products, including, but not limited to, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related applications. Since that guide was published, the FTC has filed more than 200 cases challenging false or misleading advertising of dietary supplements, foods, over-the-counter drugs and other health-related products. In addition, the FTC will only accept epidemiological or observational studies when they are considered an acceptable substitute by experts in the field and clinical studies are not otherwise feasible (p.
The FTC works to prevent fraudulent, deceptive, and unfair practices directed at businesses and consumers. .
