In the course of my career, clients have often asked for a nutshell summary of the key principles guiding the Federal Trade Commission's (FTC) action in the food and dietary supplements industries.  Two decades of experience have brought these principles into clear focus and have provided a vantage point from which to assess the risks of non-compliance.  While by no means a substitute for legal advice, the short summary below will, hopefully, provide a framework for understanding and complying with the bedrock principles governing advertising claims made by food and dietary supplement manufacturers.

The Cardinal Rule

The broad scope of FTC enforcement of advertising standards affects the ability of food and dietary supplements manufacturers to communicate with their customers on a daily basis.   At the core of the FTC's regulatory efforts is a single, basic rule:  All advertising must be truthful and non-deceptive, substantiated and not unfair.

The criteria for determining compliance with this rule relies on an assessment of how a reasonable consumer might interpret the ad in context. The FTC will consider all communication in the ad, including graphics.

In considering whether the advertiser has complied with the rule, the FTC evaluates implied as well as express claims; it examines ads for missing information that might tend to mislead the consumer; it examines the ad to determine materiality, or whether it tends to influence a consumer's decision to purchase the product and whether the evidence is sufficient to substantiate the claim. Consumer anecdotes and money back guarantees are not sufficient for the substantiation of claims.

Health claims are a common feature of dietary supplement advertising. FTC imposes a more rigorous standard for health claims. These must be supported by competent and reliable scientific evidence. We will address this in a future blog post.

Rules of Engagement

FTC looks to several criteria in order to determine when it should take action. These include the following:

• Whether FTC has primary jurisdiction to regulate the advertising.  In many cases, particularly those involving labeling, the Food and Drug Administration (FDA) has primary jurisdiction.
• Is there a pattern of deception exhibited by the company?
• Is there an effect on consumer health and safety, or a financial loss?

In such cases, FTC has several enforcement options. Civil penalties of varying amounts are very common. Corrective advertising is a second option. FTC employs cease and desist orders, which can have a serious effect on a company's livelihood.

Dietary supplements deserve special mention because FTC has targeted dietary supplement manufacturers, their advertising agencies, producers of infomercials and distributors and retailers. We will address the issue of supplements in greater detail in a future blog post.

Common Types of Challenged Claims

The following are some examples of claims that attract FTC attention, particularly in the absence of clear, prominent, qualifying language explaining the claim:

• “university studies prove”
• “90% of cardiologists….”
• advertising showing people sneezing and coughing (i.e., advertising cold care)
• before and after pictures (before: using walker; after: dancing)
• a weight loss ad failing to disclose that test subjects engaged in regular exercise and diet restriction during the test period for the product
• failing to mention side effects while referencing “without the side effects of over-the-counter” drugs
• failing to mention the product’s effect on increase in blood pressure
• “scientists now agree!” and “studied for years abroad” (require a higher level of evidence since these refer to a specific level of support)
• reliance on animal and in vitro studies
• anecdotal evidence
• “proven”
• “found effective”
• relying on “traditional use” (such as “ancient folklore remedy used for centuries”)
• reference to a book (“Miracle Cancer Cure”) in promotions for a particular dietary supplements.

FTC's enforcement priorities change periodically. However, an area of particular sensitivity is weight loss claims. FTC has cracked down on unsubstantiated weight loss claims, and we expect this trend to continue.

Disclosures

Advertisers are responsible for ensuring that all express and implied claims that an ad conveys to reasonable consumers are truthful and substantiated. When identifying these claims, advertisers should not focus only on individual phrases or statements, but should consider the ad as a whole, including the text, product name, and depictions. If an ad makes express or implied claims that are likely to be misleading without certain qualifying information, the information must be disclosed.

A disclosure can only qualify or limit a claim to avoid a misleading impression. It cannot cure a false claim. Disclosures have to be clear and conspicuous.

Avoiding Unwanted Attention from FTC and FDA

Some rules of the road for avoiding regulatory scrutiny include the following:

• FTC and FDA have overlapping jurisdiction when it comes to claims for dietary supplements, over the counter drugs, cosmetics and medical devices.
• FTC examines testimonials and endorsements.
• FTC also regulates internet advertising.

Several different kinds of claims for FDA regulated products attract FTC attention:

• Comparative Claims: FTC allows comparative claims as long as they are truthful and not deceptive.
• Efficacy Claims: These must be supported by competent and reliable evidence.

“Puffery” is permitted as long as it does not make an ad deceptive or misleading. Puffery can include “an exaggerated, blustering, and boasting statement” about a product, or a general claim of superiority over comparable products.

The takeaway here is that advertising must never suggest to the average consumer that a product prevents, treats or cures a disease, or that it is better than a comparable product without substantiation.