By Wes Siegner – On June 14, 2010, The University of Maryland School of Law hosted the first of a series of multidisciplinary meetings being held as part of a Human Microbiome Project ELSI (Ethical, Legal, Social Implications) grant to study federal regulation of probiotics. …
By Ricardo Carvajal – Senators Harkin and Hatch have introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010 (S. 3414). The statement of findings notes that FDA has been slow to implement the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, and …
By Wes Siegner – FDA recently posted a compliance program for dietary supplements that provides useful insights on where the agency is likely to focus its enforcement resources in the coming year. Illustrating FDA’s institutional biases, the agency prioritizes inspections to focus more on "non-traditional" …
By Ricardo Carvajal & Wes Siegner – FDA recently posted what appears to be the first warning letter to a firm for violations of the dietary supplement good manufacturing practice ("GMP") regulations in 21 CFR Part 111. The warning letter marks a point of transition …
By Ricardo Carvajal – During a webinar on immunity claims sponsored by the Food and Drug Law Institute, Richard Cleland, Assistant Director of FTC's Division of Advertising Practices, confirmed that enforcement actions are in the works against probiotic products that make inadequately substantiated claims. FTC …
By Ricardo Carvajal and A. Wes Siegner – According to a press release issued by FTC, the agency “has sent letters to 11 companies that promote various Omega-3 fatty acid supplements, telling them they should review their product packaging and labeling to make sure they do …
By Ricardo Carvajal – In an effort to grant FDA additional authority over dietary supplements, Senators John McCain and Byron Dorgan have introduced the Dietary Supplement Safety Act of 2010. The bill would require dietary supplement facilities to provide FDA with information on supplements and …
By Cassandra A. Soltis – The Federal Trade Commission ("FTC") made clear in a recent opinion that the Federal Food, Drug, and Cosmetic Act ("FDC Act") is not binding on the Commission in its enforcement of Sections 5 and 12 of the Federal Trade Commission Act …
By Susan J. Matthees & A. Wes Siegner – Last week FDA published a new guidance document titled “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and other Conventional Foods.” The guidance document includes a …
By Riëtte van Laack – In two little noticed speeches delivered at the Council for Responsible Nutrition’s ("CRN’s") Annual Symposium on October 22, 2009, FTC’s Director David Vladeck and FDA’s Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements. …
By Ricardo Carvajal – Several Congressional representatives wrote a letter to FDA asking the agency to “fully implement” a provision of the FDCA that allows marketing as a dietary supplement of an article previously investigated for use as a drug. Section 201(ff)(3)(B)(ii) excludes from the definition …
By Ricardo Carvajal – FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are misbranded. The letter states that, when “drug and dietary …
By Ricardo Carvajal – The Chief Administrative Law Judge (“ALJ”) at the Federal Trade Commission (“FTC”) has issued a decision that, if upheld by the Commissioners of the FTC, would dismiss an FTC complaint which alleged that a marketer of dietary supplements “disseminated” or “caused …
By Ricardo Carvajal – In an unusual step, FDA and FTC have issued a joint warning letter to the internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. According to the letter, the product “has not been …
By JP Ellison & Ricardo Carvajal – A Massachusetts district court has ordered marketers of calcium and herbal supplements touted as effective in preventing, treating, or curing diseases such as cancer, heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated …
