GMA Science Forum 2014 kicks off on April 6 in Washington, DC. The Forum will feature numerous sessions addressing scientific and regulatory issues of interest to the packaged food industry. A complete agenda is available here. HPM attorneys will help present a half-day introduction to …
By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods. In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products …
By Ricardo Carvajal – Sabra Dipping Co., LLC ("Sabra") submitted a citizen petition (Dokcket No. FDA-2014-P-0259) asking FDA to establish a standard of identity ("SOI") for hummus. The proposed SOI would define hummus as “the semisolid food prepared from mixing cooked, dehydrated, or dried chickpeas and tahini” with …
By JP Ellison – We previously posted (here and here) about the Supreme Court case that will be argued next month in which the parties are debating the proper interplay between the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Lanham Act. Briefly, the issue …
By Riëtte van Laack – Last week, FDA announced the long awaited proposal for revisions to the regulations (here and here) for the format and mandatory information included in the Nutrition Facts Box (“NFB”) and the Supplement Facts Box (“SFB”), and for the calculation of the …
By Wes Siegner – The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA …
By Riëtte van Laack – On Friday, February 7, 2014, the FTC filed its long-awaited brief in the D.C. Circuit action concerning POM Wonderful LLC’s (“POM’s”) advertising for its pomegranate products (see our previous post here). Not surprising, the FTC asserts that POM’s ads were deceptive. First, …
By Wes Siegner – On January 21 we posted on FDA’s unusual decision to reopen the comment period for the final guidance on INDs with respect to food and cosmetic research. Subsequently we learned that 60 university department heads submitted a comment to FDA’s Final IND …
Hyman, Phelps & McNamara, P.C. is participating in the Food and Drug Law Institute's Food Week 2014 being held February 10–13 in Washington, D.C. This program provides an opportunity for food law, regulation and policy stakeholders to gather practical guidance on cutting-edge issues and hear …
By Riëtte van Laack – On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s …
By Ricardo Carvajal – The Institute of Medicine (“IOM”) published a summary report of the workshop on caffeine in food and dietary supplements that IOM convened last August at FDA’s request. As noted in the introduction to the summary, the summary presents statements, recommendations, and opinions …
By Riëtte van Laack – On January 13, FDA announced the availability of two guidances concerning beverages and liquid dietary supplements: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.” Both guidances are derived from FDA’s 2009 …
By JP Ellison – We previously reported that Pom Wonderful had sought Supreme Court review of the 9th Circuit’s decision that POM’s labeling-based claims against Coke’s Minute Maid products could not proceed under the Lanham Act because such labeling was the province of the FDA and the …
By Riëtte van Laack – On January 7, the FTC announced an initiative “Operation Failed Resolution” stating that it wants to protect consumers against deceptive weight loss claims. Among other things, the FTC announced actions against four companies for advertising fad weight-loss products, issued an updated …
By Ricardo Carvajal – As we noted in a prior posting, several courts have stayed or dismissed class actions based on the doctrine of primary jurisdiction in cases that raise the question of whether a GMO-containing food can properly be labeled as “natural.” In response to …
