Last month, OTCs were in Action at a US FDA meeting, where eminent naturopathic physicians and captains of the homeopathy industry defended the current regulatory structures for the drugs, and a few sceptics were concerned with the lack of scientific-based evidence for compliance. This venerable segment of the market has long been ignored by the agency but the increasing popularity of homeopathy, the introduction of pseudo-homeopathic dietary supplements, as well as inappropriate treatment claims such as asthma, have put the alternative treatments in the spotlight.
Back in 1938, the Food, Drug & Cosmetic Act recognised the US Homeopathic Pharmacopeia as the official compendium containing monographs for homeopathic drugs. Fifty years later, The Compliance Policy Guide (CPG) gave the FDA authority to effectively police the homeopathic medicine trade for compliance in terms of appropriate OTC claims, product safety and GMP. The Federal Trade Commission helps regulate claims and advertising.
According to the CPG: The practice of homeopathy is based on the belief that disease symptoms can be cured by small doses of substances which produce similar symptoms in healthy people.
Although the efficacy of homeopathic drugs will be debated forever, the issue is further clouded by the fact that some OTC “homeopathic drugs” are not prepared with homeopathic methods of dilution, but make a homeopathic drug claim based on having a plant source. This allows these pseudo-homeopathic products to avoid dietary supplement status and the required disclaimer: “These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” It also crosses the firm line stated by Paul Mittman, Southwest College of Naturopathic Medicine & Health Sciences: A homeopathic is a drug and a dietary supplement is a food.
This is just the beginning of the FDA’s evaluation of homeopathic products, with written comments accepted until 22nd June — and it’s likely there will be some harsh and sceptical comments on homeopathy received by the FDA. However, given the entrenched status of homeopathy as a viable alternative therapy practiced by medical professionals, as well as a relatively safe profile as a mass market OTC, will the FDA overhaul their regulation? Written comments are welcome here as well!
Full coverage of the meeting will be published in the May issue of OTC INSIGHT North America.
This month, US Federal Trade Commission Chairwoman Edith Ramirez cautioned marketers of brain health supplements that the National Advertising Division is watching them. In a keynote speech at the NAD’s conference, Ramirez said companies who conduct false and misleading marketing campaigns for these products prey on consumers’ fears of ageing and hope for their children. The agency has prioritised taking action on companies that take advantage of consumers this way.
For example, the NAD’s latest action targeted SmartX from Cerebral Success, which has agreed to refrain from making a wide range of claims, such as “Cerebral Success was specifically designed as a study pill to provide an Adderall alternative for students who are taking the drug without a prescription. It is not, however, designed to treat the condition. Along with focus and mental energy (the hallmarks of Adderall), Cerebral Success was designed to increase memory and strengthen and protect the brain, which Adderall does not do.”
This type of borderline disease claim-making is so damaging to the credibility of a category that can truly help people. In fact, brain health has been hailed as the next big dietary supplement boom. Therefore, we spotlight this week’s OTC in Action, i-Health’s BrainStrong Memory Support, which has been reformulated and relaunched after reaching a settlement with the NAD regarding previous claims for cognition and memory health. Legal analysts say the settlement requires that the quality and quantity of scientific evidence must prove the specific claim for the brand, a departure from the two-study standard previously accepted. The order also includes a provision that data is collected and documented by the company.
BrainStrong’s new positioning has undergone trial by fire:
BrainStrong Memory Support is a breakthrough new formula containing gingko biloba and choline – two ingredients scientifically demonstrated to help support brain signals, sharpen focus and support a healthy memory. The website also encourages consumers to “Support your memory … and save money too!”
And the lower cost should encourage trial by consumers!
Two areas we focus on in our latest OTC.NewDirections bulletin are new regulations for dietary supplements and medical devices. In Canada, quality assurance measures are being introduced for Natural Health Products, while across the border in the US, the FDA has issued guidance to help marketers distinguish between liquid dietary supplements and beverages.