FTC Notices of Penalty Offenses: What Should You Do?
By Mark Land, M.S., RAC, AAHP President
Most of you have probably seen media mentions about almost 700 “Notices of Penalty Offenses” sent by the Federal Trade Commission (FTC) to sellers involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods.
Importantly, as FTC stated, receipt of such a letter does NOT mean that FTC has made any finding about your marketing practices. In an April 27 memo exclusive to members, AAHP Counsel Al Lorman detailed the procedural elements associated with Notice of Penalty Offenses letters and what FTC hopes to achieve with them.
Given that the notice letters failed to contain specific allegations of wrongdoing, many may be inclined to disregard this event as hijinks perpetrated by an overzealous Commission. AAHP’s recommendation, however, is that you take this as a best practice wake-up call. Specifically, what should you do in response to a Notice of Penalty Offenses letter?
In short AAHP recommends you do at least three things: First, familiarize your organization with FTC’s expectations for advertising substantiation and endorsements. Second, conduct an internal audit against best practices. Last, correct any deficiencies identified in your audit.
FTC, as you can imagine, is well published on the subject of advertising compliance. A good place to start to bring your organization up to date on FTC’s expectations is FTC’s website under the heading of “Truth in Advertising”.1 On this website you will find guidance on endorsements and substantiation of claims for health care products. FTC also has published an Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs.2
In addition to FTC, AAHP has published guidelines on advertising and labeling of OTC homeopathic medicines.3 This guideline includes an AAHP-approved disclaimer for use on OTC homeopathic drug products. Take the time to familiarize yourself with the full AAHP guideline, including the disclaimer.
Once you are familiar with the guidance available, consider an audit of your own advertising and labeling for compliance with best practices of truthfulness and substantiation. This includes websites, printed and digital advertising, and the labels on products themselves. Keep in mind that endorsements extend to health care professionals, consumers, and influencers commenting on your products.
In the immediate term, make corrections as quickly as possible if deficiencies are found. For the near and future term, consider developing procedures and processes to review advertising for compliance in advance of publication.
1 United States Federal Trade Commission Truth in Advertising https://www.ftc.gov/news-events/topics/truth-advertising (accessed May 3, 2023).
2 United States Federal Trade Commission Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs https://www.ftc.gov/news-events/news/press-releases/2016/11/ftc-issues-enforcement-policy-statement-regarding-marketing-claims-over-counter-homeopathic-drugs (accessed May 3, 2023).
3 The American Association of Homeopathic Pharmacists Consumer Advertising and Labeling Guideline for Over-the-Counter Homeopathic Medicines https://theaahp.org/position-statements/consumer-advertising-and-labeling-guideline-for-over-the-counter-homeopathic-medecines/ (accessed May 3, 2023).