On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011. We have a keen interest in the draft guidance and have previously posted on it …
By Riëtte van Laack – On November 8, 2011, Senator Durbin and Representative Waxman requested that the U.S. Government Accountability Office ("GAO") determine how the adverse event reporting ("AER") for dietary supplements system is working. Since December 22, 2007, pursuant to the Dietary Supplement and Nonprescription …
By Riëtte van Laack – Last week, Rep. Dan Burton (R-IN) introduced the “Dietary Supplement Protection Act of 2011.” Referencing the exemplary safety record of dietary supplements, the bill proposes to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to significantly …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting at the following upcoming conferences on food law and policy. The ASQ Food, Drug, and Cosmetic Division's 22nd West Coast Conference on Dietary Supplement Challenges will address cGMPs, analytical issues, the FSMA, and FDA’s draft guidance …
On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient ("NDI") notifications that FDA issued earlier this month. Our …
By Riëtte van Laack – Last week, Senator Richard Durbin (D-IL) introduced “the Dietary Supplement Labeling Act of 2011” (S. 1310). The bill proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to “improve the safety of dietary supplements.” Durbin’s bill includes a …
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
By John R. Fleder – In 2004, the Federal Trade Commission (“FTC”) brought a civil action against the marketers of products sold as “Coral Calcium Daily” and “Supreme Greens with MSM.” The FTC challenged a number of claims, including that the products allegedly made express or …
By Riëtte van Laack – On Friday April 22, 2011, a customer slapped Bayer HealthCare LLC (“Bayer”) with a class action suit in California federal court accusing Bayer of falsely and deceptively advertising the benefits of its Phillips Probiotics Colon Health (“PPCH”) supplements. The complaint alleges …
By Wes Siegner & Cassandra A. Soltis – There has been a buzz in the trade press and industry over when a company is required under the Federal Food, Drug, and Cosmetic Act ("FDC Act") to submit to the Food and Drug Administration ("FDA") a 75-day …
By Jennifer D. Newberger – After more than fifteen years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the …
By Cassandra A. Soltis – In an opinion dated April 6, 2011, Judge Beryl Howell of the U.S. District Court for the District of Columbia granted summary judgment for the FDA in a case challenging the dietary supplement good manufacturing practice (“GMP”) regulations. Alliance for Natural …
By Riëtte van Laack – Approximately three years ago, the Federal Trade Commission ("FTC") filed a complaint against Daniel Chapter One and James Fijio (“DCO”) for the advertising of four dietary supplements as cures for various cancers. The FTC ruled that DCO’s claims were deceptive and …
By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. ("Matrixx") for allegedly violating § 10(b) of the Securities Exchange Act and Exchange Commission Rule 10b-5. As …
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act § 201(ff)(3)(B) or § 301(ll) acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements …
