By Todd Harrison, Partner, and Melanie English, Associate, Venable01.12.23
Just before the 2022 holiday break, the Federal Trade Commission (FTC) released a new guidance document updating the recommendations for advertising claims about dietary supplement products that the agency has been using since 1998.
The newly released Health Products Compliance Guidance replaces the long-used guidance entitled “Dietary Supplements: An Advertising Guide for Industry” and represents a shift in the agency’s thinking concerning the supplement industry.1 It raises the expectations for substantiating advertising claims about dietary supplement products, places a greater emphasis on disclosures, and suggests that the agency plans to take a stricter stance on regulating the industry going forward.
According to the agency, ads can be deceptive not only because of what they say, but also because of what they fail to say. On its face, there is merit to this argument. An advertisement that fails to communicate that a product has significant safety risks, for example, can reasonably be called deceptive.
However, that is not the only example FTC provides in its latest guidance of an ad that is allegedly deceptive via omission. The Health Products Compliance Guidance describes an advertiser claiming that its product “can eliminate a specific mineral deficiency that results in feelings of fatigue.”2
Even if the claim is true, the FTC suggests that in an instance where the deficiency is uncommon—like if only 2% of the general population suffers from that deficiency—then the advertiser must explicitly disclose that “only the small percentage of people who suffer from the actual mineral deficiency are likely to experience any reduction in fatigue from using the product.”3
What the FTC overlooks is that the advertisement already provides consumers with information they need to evaluate the product. The consumer already knows the product can eliminate a specific mineral deficiency; it is up to the consumer to determine whether or not they possess that deficiency and whether it is worth buying the product. The proposed disclosure does not add anything unless you assume consumers would not be able to understand that, based on the advertisement, the product is primarily intended for people with a specific mineral deficiency.
Traditional uses are not always supported by modern scientific evidence, either because the ingredients simply have not yet been thoroughly studied in modern clinical trials, or because whatever studies were conducted found insignificant or mixed results.
“Traditional use” claims acknowledge the lack of modern scientific support for an ingredient’s use by explaining that the ingredient was “traditionally used” for a certain purpose. By their nature, these claims do not assert that an ingredient’s uses have a modern scientific basis.
Yet the FTC seems convinced that consumers do not understand the distinction between a traditional use and a use supported by modern science. Indeed, the agency would require a disclosure on “traditional use” claims “that there is no scientific basis for the traditional use.”4
This recommendation does not appear to be based on any actual research showing that consumers are misled by “traditional use” claims. The FTC merely suspects that it could be misleading and suggests that industry take on the burden of conducting copy tests and/or other consumer research to “confirm that consumers understand the limited nature of the claim.”5
Even some common disclaimers have been found wanting by the FTC. A disclaimer that “These results are not typical” is apparently not sufficient to explain to consumers that the results highlighted in an advertisement are not necessarily the results that most consumers can expect.7
Altogether, the FTC seems to believe that consumers are not intelligent enough to make educated decisions without exceedingly thorough disclaimers.
While not all public health recommendations will be sufficient substantiation, the blanket recommendation that they never be relied on as substantiation seems ridiculous. Such recommendations are put out by reliable governmental and professional organizations specifically so that people can rely on them in lieu of having to redo all the underlying research themselves.
However, there was never any opportunity to comment on the guidance document before it was released, because the FTC continues to operate under the pretense that some of its major policy changes are merely “guidance” and carry no force of law. While the distinction between guidance and rulemaking is admittedly sometimes murky, guidance documents are generally limited to providing an agency’s interpretations of an existing rule; this “guidance” goes further.
It is the FTC’s first specific stance on claims about dietary supplement products since 1998. It references prior case precedent, it sets expectations for the future using language that sounds like a mandate—“shouldn’t,” “it can’t,” “will need to be,” etc.—and it will likely be cited by plaintiffs litigating alleged false advertising cases across the U.S.
Describing this document as a mere interpretative rule or a general statement of policy stretches credulity, and the FTC should be following the Administrative Procedure Act’s requirements for rulemaking before releasing these sorts of major decisions.9
The public deserves the chance to weigh in on policies that will affect them and to push back against proposals that would involve agency overreach. Releasing rulemaking under the guise of guidance documents is expedient, but ultimately a violation of the Administrative Procedure Act. Long-term, this action leads down a path to fomenting public frustration with their inability to influence policies that affect them.
The most disappointing part of this latest guidance from the FTC is that it is not, fundamentally, a bad idea to promulgate new regulations concerning the advertising of dietary supplement products. The industry has come a long way since 1998, and the ingredients that are now being used and the claims being made about those ingredients have evolved.
The FTC can play a role in promoting fairness in this evolving industry by punishing bad actors and creating room for good actors to shine. Honest business owners do not like to see their customers go to competitors who are making false and misleading claims, and the FTC can help to prevent that from happening. The agency is shortchanging not only the public, but itself, and undermining its credibility by continuing to promulgate stringent regulations via suggestion without any input from affected industries. Going forward, the agency should make more of an effort to engage in the legal processes that promote faith in our government institutions.
About the Authors: Todd Harrison is Partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com. Melanie English is an Associate at Venable's Food and Drug Law practice. Prior to joining Venable, she was an intern at the U.S. Department of Transportation (USDOT), where she reviewed and edited regulations for the Office of Regulation within the Office of the General Counsel. During law school, English was a staff editor on the New York University School of Law Moot Court Board. She was also a Venable summer associate.
2. Health Products Compliance Guidance at 7.
3. Id.
4. Health Products Compliance Guidance at 29.
5. Id.
6. Health Products Compliance Guidance at 9–10.
7. Health Products Compliance Guidance at 27.
8. Health Products Compliance Guidance at 14.
9. See 5 U.S.C. § 553(b)
The newly released Health Products Compliance Guidance replaces the long-used guidance entitled “Dietary Supplements: An Advertising Guide for Industry” and represents a shift in the agency’s thinking concerning the supplement industry.1 It raises the expectations for substantiating advertising claims about dietary supplement products, places a greater emphasis on disclosures, and suggests that the agency plans to take a stricter stance on regulating the industry going forward.
FTC Doubts Consumer Judgement
The guidance is also an instance of the agency overstepping its authority to attempt to paternalistically protect consumers from their own perceived ignorance.According to the agency, ads can be deceptive not only because of what they say, but also because of what they fail to say. On its face, there is merit to this argument. An advertisement that fails to communicate that a product has significant safety risks, for example, can reasonably be called deceptive.
However, that is not the only example FTC provides in its latest guidance of an ad that is allegedly deceptive via omission. The Health Products Compliance Guidance describes an advertiser claiming that its product “can eliminate a specific mineral deficiency that results in feelings of fatigue.”2
Even if the claim is true, the FTC suggests that in an instance where the deficiency is uncommon—like if only 2% of the general population suffers from that deficiency—then the advertiser must explicitly disclose that “only the small percentage of people who suffer from the actual mineral deficiency are likely to experience any reduction in fatigue from using the product.”3
What the FTC overlooks is that the advertisement already provides consumers with information they need to evaluate the product. The consumer already knows the product can eliminate a specific mineral deficiency; it is up to the consumer to determine whether or not they possess that deficiency and whether it is worth buying the product. The proposed disclosure does not add anything unless you assume consumers would not be able to understand that, based on the advertisement, the product is primarily intended for people with a specific mineral deficiency.
History of Use
The same mistrust of consumers’ discernment is apparent in the FTC’s new approach to “traditional use” claims. There are a wide variety of dietary supplements, particularly botanical supplements, with a long history of use as traditional medicine in the U.S. and around the world.Traditional uses are not always supported by modern scientific evidence, either because the ingredients simply have not yet been thoroughly studied in modern clinical trials, or because whatever studies were conducted found insignificant or mixed results.
“Traditional use” claims acknowledge the lack of modern scientific support for an ingredient’s use by explaining that the ingredient was “traditionally used” for a certain purpose. By their nature, these claims do not assert that an ingredient’s uses have a modern scientific basis.
Yet the FTC seems convinced that consumers do not understand the distinction between a traditional use and a use supported by modern science. Indeed, the agency would require a disclosure on “traditional use” claims “that there is no scientific basis for the traditional use.”4
This recommendation does not appear to be based on any actual research showing that consumers are misled by “traditional use” claims. The FTC merely suspects that it could be misleading and suggests that industry take on the burden of conducting copy tests and/or other consumer research to “confirm that consumers understand the limited nature of the claim.”5
More Disclaimers
Before asking industry to add a new disclaimer to their advertising, one would think a regulatory agency would already have done or sought out some of that research on its own. Yet instead, the FTC is demanding a variety of disclaimers without providing any evidence that consumers are incapable of understanding advertising claims as they currently exist. Stating research is “preliminary” is no longer enough to convey that a study is limited and not conclusive; the FTC would require a disclaimer, apparently explaining what “preliminary” means.6Even some common disclaimers have been found wanting by the FTC. A disclaimer that “These results are not typical” is apparently not sufficient to explain to consumers that the results highlighted in an advertisement are not necessarily the results that most consumers can expect.7
Altogether, the FTC seems to believe that consumers are not intelligent enough to make educated decisions without exceedingly thorough disclaimers.
Scientific Substantiation
The demand for much more thorough disclaimers is not the only area in which the new dietary supplement guidance sets more stringent standards than the 1998 guidance. The new guidance also has higher expectations for scientific substantiation for claims about dietary supplement products, to such an extent that the agency states “advertisers shouldn’t rely on public health recommendations, such as advisories from a medical organization, as substantiation.”8While not all public health recommendations will be sufficient substantiation, the blanket recommendation that they never be relied on as substantiation seems ridiculous. Such recommendations are put out by reliable governmental and professional organizations specifically so that people can rely on them in lieu of having to redo all the underlying research themselves.
It is the FTC’s first specific stance on claims about dietary supplement products since 1998. It references prior case precedent, it sets expectations for the future using language that sounds like a mandate—“shouldn’t,” “it can’t,” “will need to be,” etc.—and it will likely be cited by plaintiffs litigating alleged false advertising cases across the U.S.
Missed Opportunity
The stringency of the new guidance and the areas in which it overreaches are the sort of issue that could potentially have been resolved through a notice and comment period. At the very least, a notice and comment period would have provided industry with an opportunity to read the FTC’s proposed recommendations and provide input. Even if their input did not ultimately affect the content of the guidance document, it would have helped with public buy-in to have had an opportunity to be involved in the process.However, there was never any opportunity to comment on the guidance document before it was released, because the FTC continues to operate under the pretense that some of its major policy changes are merely “guidance” and carry no force of law. While the distinction between guidance and rulemaking is admittedly sometimes murky, guidance documents are generally limited to providing an agency’s interpretations of an existing rule; this “guidance” goes further.
It is the FTC’s first specific stance on claims about dietary supplement products since 1998. It references prior case precedent, it sets expectations for the future using language that sounds like a mandate—“shouldn’t,” “it can’t,” “will need to be,” etc.—and it will likely be cited by plaintiffs litigating alleged false advertising cases across the U.S.
Describing this document as a mere interpretative rule or a general statement of policy stretches credulity, and the FTC should be following the Administrative Procedure Act’s requirements for rulemaking before releasing these sorts of major decisions.9
The public deserves the chance to weigh in on policies that will affect them and to push back against proposals that would involve agency overreach. Releasing rulemaking under the guise of guidance documents is expedient, but ultimately a violation of the Administrative Procedure Act. Long-term, this action leads down a path to fomenting public frustration with their inability to influence policies that affect them.
The most disappointing part of this latest guidance from the FTC is that it is not, fundamentally, a bad idea to promulgate new regulations concerning the advertising of dietary supplement products. The industry has come a long way since 1998, and the ingredients that are now being used and the claims being made about those ingredients have evolved.
The FTC can play a role in promoting fairness in this evolving industry by punishing bad actors and creating room for good actors to shine. Honest business owners do not like to see their customers go to competitors who are making false and misleading claims, and the FTC can help to prevent that from happening. The agency is shortchanging not only the public, but itself, and undermining its credibility by continuing to promulgate stringent regulations via suggestion without any input from affected industries. Going forward, the agency should make more of an effort to engage in the legal processes that promote faith in our government institutions.
About the Authors: Todd Harrison is Partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com. Melanie English is an Associate at Venable's Food and Drug Law practice. Prior to joining Venable, she was an intern at the U.S. Department of Transportation (USDOT), where she reviewed and edited regulations for the Office of Regulation within the Office of the General Counsel. During law school, English was a staff editor on the New York University School of Law Moot Court Board. She was also a Venable summer associate.
References
1. Federal Trade Commission, Health Products Compliance Guidance at 1 (Dec. 2022) (hereinafter “Health Products Compliance Guidance”)2. Health Products Compliance Guidance at 7.
3. Id.
4. Health Products Compliance Guidance at 29.
5. Id.
6. Health Products Compliance Guidance at 9–10.
7. Health Products Compliance Guidance at 27.
8. Health Products Compliance Guidance at 14.
9. See 5 U.S.C. § 553(b)
