Regulators Still Enforcing Health Marketing ClaimsWritten by Richard Newman
February 4, 2013 # 8:56 am # Legal Challenges, Specials # No Comments
The Federal Trade Commission and numerous state Attorneys’ General continue to actively police deceptive health-related marketing claims, including those relating to weight loss products. Marketers in the know evaluate products and related data first, and then create advertising copy to reflect what the product has actually been proven to do.
Make no mistake about it, there is a higher standard for substantiating health and weight loss claims for dietary supplements. Regulators require “competent and reliable scientific evidence.”
In case you have not studied the myriad of available consent judgments regarding weight loss claims, “competent and reliable scientific evidence” means well-controlled human clinical studies of the product, or of an essentially equivalent product, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representations are true.
Essentially equivalent is, in turn, defined as a product that contains the identical ingredients, except for inactive ingredients (e.g., colors and fillers), in the same form and dosage, and with the same route of administration, as the covered product — provided that the covered product may contain additional ingredients if reliable scientific evidence generally accepted by experts in the field demonstrates that the amount and combination of additional ingredients is unlikely to impede or inhibit the effectiveness of the ingredients in the essentially equivalent product.
As referenced above, regulators will, without a doubt, consider whether existing studies are indeed consistent with the body of scientific evidence. The FTC is increasingly looking for consensus within the scientific community.
The foregoing standards are set forth with specificity in numerous regulatory settlement orders and should be considered a baseline enforcement threshold. So, such clinical studies will have to be conducted on the product or on a substantially equivalent product, and conform to rigorous protocol and design standards.
It is unlikely that the FTC will accept ingredient testing unless the advertising makes very clear that the efficacy claims being made are limited to the ingredients rather than the product. All those in the stream of commerce, from advertisers to publishers, should be careful not to make express or implied claims that the product has been proven or tested absent well-controlled clinical studies.
Further, marketers must not simply rely upon conclusions in clinical studies. Rather, a careful review of relevant protocols and data is imperative to ensure consistency with scientific conclusions.
Another common mistake continues to be that testimonials from satisfied customers will do the trick to get around the substantiation requirement. They will not. Testimonials are not “competent and reliable scientific evidence.” Unless you are comfortable with the likelihood of a regulator pulling compliance threads, do not try an end-around of the requirement through a testimonial.
If you do not have reliable data to prove the underlying representation, do not make it in the first place. Consumer testimonials inherently involve making efficacy claims that have to be substantiated. Whether your advertisement says “Lose 10 pounds…” or “I lost 10 pounds…,” competent scientific substantiation to back-up the claims is required.
The overall net impression of ad copy upon a reasonable consumer is what counts. Other red-flag weight loss claims that are almost always considered deceptive include, without limitation, that a product can cause weight loss without diet or exercise or can cause permanent weight loss.
If the disclosure of information is necessary to prevent an advertisement from being considered deceptive, it must be made clearly and conspicuously. A miniscule, fine-print footnote below the fold will not mitigate potentially liability and is arguably tantamount to having no disclosure at all.
The relationship between the principle claims and disclosures is vitally important when assessing marketing do’s and don’ts. For more information on the science of maintaining conversions while substantiating claims and product efficacy, consult with an advertising law attorney. It is often more cost-effective to involve regulatory compliance counsel early on in the creative compliance process.
Those that are engaged in campaigns within high-risk verticals are well-advised to assume that they are being carefully monitored. Regulators methodically scour the Internet for problematic ad copy. Methodologies and underlying protocols of clinical studies upon which all those in the stream of commerce are relying promises to remain front-and-center for quite some time.
Do not stand out unless you are fully compliant or have a high level of risk tolerance. If you draft aggressive ad copy first and the try to gather reliable studies that conform to it, you are asking for trouble.
Information conveyed in this article is provided for informational purposes only and does not constitute, nor should it be relied upon, as legal advice. This information is not intended to substitute for obtaining legal advice from an attorney. No person should act or rely on any information in this article without seeking the advice of an attorney.