FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence


ePT--the Electronic Newsletter of Pharmaceutical Technology

On Apr. 27, 2012, FDA issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine (DMAA). FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

Under the law, manufacturers of dietary ingredients are responsible for notifying FDA within 75 days of marketing their products with evidence that supplements containing new dietary ingredients are safe. "Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, PhD, Director of FDA’s Dietary Supplement Program, in an FDA press release.

FDA warned the companies in the letters that because synthetically produced DMAA is not a dietary ingredient it is “not eligible to be used as an active ingredient in dietary supplements.”

According to FDA, DMAA “is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.” Forty-two adverse event reports regarding products containing DMAA have been submitted to FDA.

The companies have 15 business days to provide FDA with the steps they plan to take in response to the Warning Letters. The companies cited in the FDA press release are listed below:

Exclusive Supplements
Fahrenheit Nutrition
Gaspari Nutrition
iSatori Global Technologies, LLC
Muscle Warfare, Inc.
MuscleMeds Performance Technologies
Nutrex Research
SEI Pharmaceuticals
SNI LLC
USP Labs, LLC

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here