B.F. Ascher Halts Supplement/OTC Combo Sales Following FDA Warnings
This article was originally published in The Tan Sheet
Executive Summary
B.F. Ascher has discontinued the sale of its Melagesic PM dietary supplement/OTC combination in response to FDA's decision the product is an unapproved new drug, according to the agency
You may also be interested in...
FDA Warning Letter Review Suggests Aggressive Action Needed, Troy Says
The FDA Office of Chief Counsel's review of warning and untitled letters suggests the agency should be taking more aggressive enforcement actions, Chief Counsel Daniel Troy suggested Feb. 21
Omni Nutraceuticals
Company offers to delete statement "Healthy long-term joint support" from Inholtra Joint Pain, Joint Pain Plus dietary supplement/OTC combo products "if necessary to resolve all issues raised" by FDA, firm tells agency in Feb. 13 letter. Omni also says "active/inactive" distinction FDA made in its Feb. 8 letter is invalid because DSHEA authorizes use of supplements intended to affect structure, function of the body "without subjecting them to regulation as drug ingredients" (1"The Tan Sheet" Feb 18, 2002, p. 7). Company notes it "remains willing to meet with FDA to resolve outstanding issues"...
OTC/Dietary Supplement Combination Guidance “Unlikely” – FDA
FDA has no near-term plans to issue a formal guidance on dietary supplement/OTC combination products