By Susan J. Matthees – The National Advertising Division (“NAD”) of the Council of Better Business Bureaus recently concluded that claims that Procter & Gamble’s Crest Sensitivity Treatment & Protection Toothpaste could provide relief from sensitive teeth “within minutes” should be discontinued. Colgate-Palmolive brought the challenge …
By Ricardo Carvajal – On November 18, the United States District Court for New Jersey granted FTC’s motion for a finding that Lane Labs violated an order agreed to by the parties in 2000. In part, that order requires Lane Labs’ health-related marketing claims to be …
By Kurt R. Karst – We had hoped that our post from earlier this week, titled Pending DESI Program Proceedings – The List, would stimulate some discussion. And it did. One comment in particular that we received from an authoritative source caught our attention and deserves greater …
By James R. Phelps – Many seasoned FDA watchers are surprised by the kerfuffle raised when HHS overturned FDA’s plan to allow Plan B emergency contraception available over the counter (see here and here). This is first time HHS has publicly put its thumb on the …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published its long awaited final rule in the Federal Register today (76 Fed. Reg. 77,330 (Dec. 12, 2011)) placing carisoprodol into schedule IV of the federal Controlled Substances Act (“CSA”). Federal scheduling of carisoprodol follows control …
By Kurt R. Karst – For years we’ve heard rumors of a relatively current list, compiled by FDA, of proceedings pending under the Drug Efficacy Study Implementation (“DESI”) program. At one time, in the early 1980s, the list was included as an addendum to the Orange …
By Riëtte van Laack – On December 5, 2011, the Food Safety Inspection Service (“FSIS”) of the USDA proposed to amend its regulations concerning label approval of meat and poultry products. The proposed rule would further expand the types of labels that do not require pre-market …
On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011. We have a keen interest in the draft guidance and have previously posted on it …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 Kurt R. Karst – Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a mid-level to senior associate or counsel with substantial experience in medical device law and regulation to assist with a growing practice. Strong writing skills are required. Compensation is …
By Jennifer D. Newberger – On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the “Novel Device Regulatory Relief Act of 2011.” The bill is intended to amend section 513 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process …
By Kurt R. Karst – On December 7, 2011, FDA will publish a Federal Register notice – a prepublication version of which is available here – announcing a December 16th public meeting and comment period (Docket No. FDA-2011-N-0326) to discuss the Agency’s proposed recommendations for a …
By Ricardo Carvajal - Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril. For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …
By Riëtte van Laack – Representative Louise Slaughter (D-NY) recently sent a 4-page letter to FDA expressing her discontent with the Agency’s action (or lack thereof) related to antibiotic use in animal agriculture. Specifically, Rep. Slaughter criticizes: 1. FDA’s delay in finalizing the industry guidance #209, titled the …
By Ricardo Carvajal – FDA issued a warning letter to a food manufacturer for labeling as “all natural” a product that contains disodium dihydrogen pyrophosphate, purportedly a synthetic chemical preservative. The letter cites an alleged violation of FDC Act § 403(a)(1), under which a food is …
