What Dietary Supplement Marketers Must Know About FTC Claim Substantiation Standards

This guest post is brought to you by Richard Newman. He is an attorney at Hinch Newman LLP focusing on the U.S. advertising and digital media matters. 

The Federal Trade Commission is responsible for protecting consumers and competition by targeting anticompetitive, deceptive, and unfair business practices.  A marketer’s failure to possess and rely upon a reasonable basis for objective express and implied claims constitutes an unfair and deceptive act or practice in violation of Section 5 of the FTC Act.

The agency aggressively polices dietary supplement advertising claims.  It investigates and takes action against marketers that make baseless and overstated claims about products marketed as dietary supplements.

In fact, both the FTC and the Food and Drug Administration have enforcement programs designed to protect consumers from false and misleading marketing claims about the safety and benefits of products marketed as dietary supplements.

From a labeling standpoint, the FDA generally looks at whether claims on dietary supplement product labels and other packaging materials are true and accurate.  The agency also oversees manufacturing, content, purity, and safety.

The FTC looks at the truth and accuracy of any claims made in dietary supplement advertising and marketing.  FTC attorneys scrutinize claims made on televisions, radio and in print ads, as well as social media and online marketing.

The FTC and FDA work together to monitor claims made on websites or in other online marketing.  In fact, the FTC’s efforts to regulate digital claims made on websites recently resulted in updated guidance like the .com Disclosures.

Marketers are responsible for ensuring that disclosures are made clearly and conspicuously, both in terms of size and location.  A disclosure placed in a footer, instead of in close proximity to the representation, is unlikely to be viewed by FTC as sufficient.  Similarly, disclosures in “mouse-print” size (very small) are also unlikely to be viewed as compliant.

To sum up:

• Advertisers making false claims about the product will be punished  (Ouch!)
• FTC checks advertising materials on TV, radio, print ads, social media, websites – and all your online ads
• It’s not enough to have a disclosure “somewhere” on your website or a landing page. Disclosure has to be readable and “close” to the product

Dietary Supplement Claim Most Likely to Trigger Regulatory Action

Claims of “treatments” or “cures” for diseases like Alzheimer’s, cancer, heart disease, arthritis, opiate addiction, and others cause regulatory agencies to salivate.  Dietary supplements cannot lawfully claim to diagnose, mitigate, treat, or prevent disease.  Unsubstantiated claims targeting vulnerable populations such as children and the elderly, and claims exploiting emerging health threats are routinely enforcement triggers.

Do You Have Scientific Evidence?

In addition to the focus on proper disclosures, pre-dissemination claim substantiation (meaning, supporting evidence for claims made in advertising) continues to be one of the most important issues for the agency and perhaps the most common cause of investigations and litigation.

Marketers must always ensure that sufficient scientific evidence to support claims for products exists.  For heath claims, the standard is “competent and reliable scientific evidence.”

Product categories that draw heightened attention from FTC are dietary supplements and nutraceuticals, health products, personal care products, weight-loss products, products promoting increased cognitive function and consumer credit products.  The focus on health claims made online extends to FDA, as well.

⚡The FDA uses impermissible disease claims made online as evidence of the intent to sell products as drugs.

Marketers must be prepared to produce strong science in support of claims, or they risk disgorgement and onerous consent decrees.

What Supporting Evidence Do You Need?

A more rigid standard of randomized, double-blind, placebo-controlled studies remains the “gold standard” for claim substantiation.  However, the claim substantiation standard for dietary supplement marketers has recently become somewhat of a moving target.

For years, the FTC sought to raise the substantiation standard for dietary supplements, taking the position that multiple drug-level clinical trials were required, despite no law or guidance requires that.  Countless companies acquiesced to this standard via consent judgments.

Recently, however, there has been judicial resistance to the FTC’s own dietary supplement substantiation standard that has resulted in potentially broad ramifications for the dietary supplement industry.

For example, at least one court has held that dietary supplements are not drugs and cannot be regulated as drugs, that dietary supplement marketers are permitted to make truthful claims that are supported by reasonably competent and reliable scientific evidence, and that the scientific evidence need not necessarily come from drug-level clinical trials.

In some circumstances, other types of scientific studies and data may potentially be permissible.  In some circumstances, while randomized, double-blind, placebo-controlled studies may constitute solid support for claims, they may not always be required.  Additionally, in some circumstances, more than one randomized, double-blind, the placebo-controlled study may not be required.

So, the standard has seemed to have morphed into, “it depends.”

Marketers should consult with experienced advertising compliance counsel to assess the myriad factors involved in this crucial analysis, including, but not limited to, the overall body of scientific data, the opinions of experts in the relevant field, contradictory evidence and statistical significance of findings.  Once the FTC knocks on your door, it is often too late.

Key takeaways here:

• You can’t claim that your supplement treats Alzheimer’s, cancer, heart disease, arthritis, opiate addiction, etc.
• Targeting vulnerable populations such as children and the elderly is extremely risky (especially if you don’t have enough supporting evidence)
• You always need “competent and reliable scientific evidence”
• Prepare for potential problems if you cannot provide “randomized, double-blind, placebo-controlled studies” to support your claims

Pre-Dissemination Substantiation

It is not enough for a marketer to possess the requisite level of substantiation when the FTC knocks on its door.  While this issue is often overlooked by marketers, it is never overlooked by the FTC.

Marketers must possess substantiation before disseminating a claim.  While the FTC has, on occasion, exercised its discretion to consider supporting materials developed after dissemination, the exercise is not typically one that is likely to result in an exculpatory decision.

The FTC emphasizes that as a matter of law, marketers lacking a reasonable basis before an ad is disseminated (published) violate Section 5 of the FTC Act, and are subject to prosecution.  Thus, the discretion and flexibility to consider additional substantiating evidence is sometimes used when deciding, before issuance of a complaint, whether there is a public interest in proceeding against a marketer; when assessing the adequacy of the substantiation an advertiser possessed before a claim was made; and when deciding the need for or appropriate scope of an order to enter against a marketer that lacked a reasonable basis prior to disseminating an advertisement.

The FTC will not postpone action while marketers create post-claim substantiation to prove the truthfulness of claims.  Subsequent evidence of truthfulness will typically not absolve a marketer of liability for failing to possess prior substantiation for a claim.

The FTC focuses instead on whether existing evidence that claims are true should lead it to exercise its prosecutorial discretion to decline to initiate a law enforcement proceeding.  Sometimes, but not often enough to warrant taking such a chance, if available post-claim evidence proves that the claim is true, the FTC can decide that a marketer’s violated of the prior substantiation requirement does not warrant enforcement.

More often, post-claim evidence is accepted by the FTC in its assessment of whether apparent deficiencies in the pre-claim substantiation materials have no practical significance.  In evaluating the adequacy of prior substantiation, the FTC typically considers only post-claim substantiation that sheds light on pre-existing substantiation. Thus, marketers will usually not be allowed to create entirely new substantiation simply because their prior substantiation was inadequate.

Finally, the FTC retains the discretion to use post-claim evidence in determining the need for or appropriate scope of an order to be entered against a marketer that lacked a reasonable basis. Thus, when additional evidence is offered for the first time following receipt of a civil investigative demand (CID) or in an enforcement action suggests that the claim is true, the FTC may frame a narrower order than if there had been no post-claim evidence.

Things to remember:

• Didn’t provide enough evidence in the first place? Too bad, when the FTC goes after you, most likely it would be too late to prove the truthfulness of your claims

Attorney advertising.  Informational purposes only. Not legal advice.  

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