With increasing regularity and in the wake of the recent Supreme Court holding that the Federal Trade Commission lacks authority to pursue monetary relief in federal court pursuant to Section 13(B) of the FTC Act, the regulatory agency has recently been initiating investigations via civil investigative demands (CIDs) into alleged false, misleading and unsubstantiated representations in violation of Section 8023 of the Opioid Addiction Recovery Fraud Prevention Act of 2018 (the Act).  Such investigations pertain, in part, to the advertising, marketing and sale of products that tout an array of substance use disorder treatments, cures and preventative benefits.

The Act provides that it is unlawful to engage in an unfair or deceptive act or practice with respect to any substance use disorder treatment service or substance use disorder treatment product.  Importantly, Section 8023 of the Opioid Addiction Recovery Fraud Prevention Act of 2018 authorizes the Federal Trade Commission to seek civil penalties for unfair or deceptive acts or practices with respect to any substance use disorder treatment service or substance use disorder treatment product.  This article focuses upon substance use disorder treatment products.

The term ‘substance use disorder treatment product’ means a product for use or marketed for use in the treatment, cure, or prevention of a substance use disorder, including an opioid use disorder.

In 2018, the Federal Trade Commission and the U.S. Food and Drug Administration warned numerous marketers and distributors of opioid cessation products of concerns that they may have been illegally marketing products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.

Products that promise miracle cures or fast results are more likely to draw regulatory scrutiny.  As will claims that a product provides a benefit when it does not.  For example, stating or implying that a claim is meaningfully supported by appropriate scientific research, when it is not.  Both the FTC and FDA monitor advertising claims about dietary supplements and other health products – and those claims have to be true, accurate and supported by competent and reliable scientific evidence.

In general, FTC attorneys - when investigating potential violations of the Act - inquire about, without limitation, the number of units sold and who they were sold to, sales, refunds and chargebacks, websites and social media pages referring or relating to the product, the individuals responsible for the content of each website and social media page, platforms upon which the product is advertised, keywords used to effect the placement of advertisements, individuals responsible for creating promotional materials, individuals responsible for developing substantiation and human clinical studies testing the efficacy of the product,  FTC investigations also seek typically seek documents that include, without limitation, copies of advertisements, relevant scientific literature, communications with third-parties, consumer complaints and consumer reviews.

The types of health-related advertising claims that could potentially fall within the purview of the Act, thereby triggering an FTC investigation, is somewhat broad.  This article should therefore be of interest to digital marketers that may fall within the Act’s scope.  Contact experienced FTC defense counsel if you are interested in discussing the implementation of preventative measures, or if you have received a CID from the Federal Trade Commission inquiring into whether there has been a violation of the Act.