Compliance Makes All the Difference

By Mark Land, M.S., RAC, AAHP President

The May issue of the AAHP newsletter examined the work of the Federal Trade Commission (FTC) while this issue examines the Food and Drug Administration’s (FDA) Office of Compliance. There are parallels and differences between both organizations. AAHP Counsel Al Lorman’s article discusses FTC’s April 13 notices on potential penalty offenses. In this instance FTC sent letters to approximately 670 companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, or functional foods found in chain drug stores that may have violated FTC laws. Among many motivations, FTC is likely exercising soft authority to create awareness for its Health Products Compliance Guidance published four months earlier. If you haven’t read the guidance yet, take time to do so. It promotes FTC’s wide-net approach for the Commission's claims substantiation expectations.

Also in this issue, we give relevant highlights of the FDA Office of Compliance’s (OC) annual report. As the title of the office implies, FDA’s OC has broad surveillance and enforcement authority over compliance related matters. In its annual report, OC mentions homeopathic drug products twice. First, its recommended to not label homeopathic cough/cold medications for children under 4 years of age. Second, there’s a mention of a campaign to test aqueous-based homeopathic products for microbiological quality. Poor microbial quality in the manufacturing of homeopathic OTCs resulted in several warning letters to homeopathic industry members. Finally, of the 10 most recent warning letters issued by FDA: five were signed by representatives of the Office of Compliance.

Both FDA and FTC exercise authority over the industry but most recently in different ways. FTC is amplifying its limited resources through a well-publicized notice of penalty offenses campaign. FDA’s OC on the other hand is proactively testing high-risk products and products for vulnerable consumer populations, and taking action following adverse inspection outcomes. By comparison FDA’s OC approach appears to be much more grounded in facts while FTC is operating in a theorized view of the market. Each organization is addressing compliance issues in a manner that represents its organizational mandates and resources.

To protect your consumers and your business, take advantage of the learnings available in the FDA warning letters database. Search under the word “homeopathic” for a list of relevant industry warning letters. Also, take advantage of the information available in FTC’s Health Products Compliance Guidance. Examine your own operations and product labels for opportunities to reduce risk to consumers and from regulators.

As an aid to your compliance program, AAHP is hosting a half-day intensive GMP Summit in mid-October. We plan to have a speaker from FDA’s Office of Compliance, a general homeopathic GMP presentation, and a discussion of microbiological quality of non-sterile dosage forms. Watch for information to come and registration to open.