FDA Enforcement Activity Heats Up

FDA Enforcement Activity Heats Up

WASHINGTONThe Food and DrugAdministration (FDA) has increased its enforcement activity in the dietarysupplement market, addressing unproven disease claims in both unapproved hormonereplacement therapies and fruitbased products. The agency also announced itspartnership with federal agencies from Mexico and Canada has produced more than700 compliance actions against bogus and misleading weight loss advertising andschemes that have defrauded consumers in the three countries.

FDA joined Federal Trade Commission (FTC) actions againstcompanies marketing unapproved alternative hormone therapies with diseaseclaims. FTC sent letters to operators of 34 Web sites that advertise markethormone replacements as preventions or treatments for diseases such as cancer,heart disease, or osteoporosis, advising the businesses such claims are illegal.FTC strongly urged the companies to amend the sites and directed them to FTCpublications Dietary Supplements: An Advertising Guidefor Industry (www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm)and Frequently Asked Advertising Questions: A Guide forSmall Business (www.ftc.gov/bcp/conline/pubs/buspubs/adfaqs.htm). In conjunction, FDA sent warning letters to 16 hormonereplacement companies, advising them of possible violations of the Food, Drugand Cosmetic Act (FDCA). The letters list the suspect claims, note the possiblelaw violations, and state the consequences of noncompliance.

Michael McGuffin, president of the American Herbal ProductsAssociation (AHPA) noted while the Internet has created new avenues forcommerce, it has also created another arena for potential regulatoryenforcement, especially for those companies that are not prudent in theirmarketing. He reported AHPA released a guidance document on this subject in July2005. It can be found at www.ahpa.org/guidelines.htm.

FDA also sent warning letters to 29 companies thatmanufacture, market or distribute products made from cherries and other fruits,advising the companies to stop making unproven claims on product labels and ontheir respective Web sites that claim their fruit products treat or preventdisease. FDA advised firms failing to take prompt corrective measures may faceFDA enforcement action without further noticeincluding seizure of theproducts, as well as injunctions or criminal sanctions. A list of the companiesand offending products can be found at www.cfsan.fda.gov/~dms/chrylist.html.

The OFPA clarifications include: allowances for food additivesand processing aids, including 500 food contact substances, without publicreview; permission for continued antibiotic treatment and genetically engineeredfeeding of young cows prior to their conversion to organic production; andalllowance of loopholes that emergency substitution of non-organic ingredientsfor organic ingredients without public notification.