Navigation Links
FDA Takes Enforcement Action Against Pennsylvania Dietary Supplement Maker
Date:11/23/2011

SILVER SPRING, Md., Nov. 23, 2011 /PRNewswire-USNewswire/ -- The FDA today took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations. The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size. This company's compliance date came into effect in 2010, and they did not meet the relevant cGMP requirements after that date.

The FDA requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies. The cGMP regulations require manufacturers to ensure quality in their dietary supplements by controlling all aspects of their processes and procedures. MADE makes more than 400 dietary supplements, including vitamins and minerals, under the brands "Sci-Fit," "Nature's Science" and "For Store Only." ATF purchases dietary supplements exclusively from MADE and distributes them throughout the United States.

"Dietary supplements have a significant role in the public's health," said Dara Corrigan, associate commissioner for regulatory affairs.  "Today's injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes."

The government's complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, alleges that in addition to "adulterating" and "misbranding" their final products, the manufacturer and its owner failed to report serious adverse events associated with their products.  In one case an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more information:
Warning Letter, March 11, 2004
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm170182.htm

Warning Letter, November 19, 2004
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2004/ucm146681.htm

Seizure, January 12, 2006
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108577.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Visit the FDA on Facebook and Flickr.
RSS Feed for FDA News Releases [what is RSS?]

Media Inquiries: Pat El-Hinnawy, 301-796-4763 or 202-557-6531, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Heartland Bridge Capital Takes Equity Stake in Biotech Firm HepatoChem
2. Pfizer Overtakes GSK but Trails Roche in PharmaDeals Corp-METRx Analysis of Deal Activity
3. Deloitte Stakes Claim in Drug Safety & Regulatory Consulting Market With Acquisition of Intrasphere Technologies, Inc. Assets
4. UK Chalks Up $253 Million in Investment in Q2 2011: Oxford Cluster Takes the Largest Bite of the Apple
5. Greenway Takes Leadership Role in Multiple Regional Extension Center Initiatives
6. St. Davids HealthCare Takes Robotic-Assisted Surgery to the Next Level With the Texas Institute for Robotic Surgery at St. Davids North Austin Medical Center
7. SinoFresh Healthcare, Inc. Takes Groundbreaking Products to Europe
8. Covance Reports Third Quarter Financial Results and Takes Actions to Strengthen Future Performance
9. FDA Takes Appropriate Action to Regulate Electronic Cigarettes and Protect Public Health
10. For Eyes Optical Takes Man to Places Hes Never Been Before in Humorous New TV Campaign
11. Informed Medical Communications Takes the Lead in Response to FDAs Bad Ad Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/9/2017)... 9, 2017  Semler Scientific, Inc. (OTCQB: SMLR), ... to improve the clinical effectiveness and efficiency of ... first quarter ended March 31, 2017. ... customers to identify when preventive care options are ... like heart attacks or strokes occur," said ...
(Date:5/6/2017)... Provista , a proven leader in the supply chain industry ... Jim Cunniff as the company,s new president and CEO. ... Provista, including most recently serving as the president and CEO ... He assumed his new role with Provista on May 1, ... says Jody Hatcher , president, Sourcing and Collaboration Services ...
(Date:5/4/2017)... 4, 2017  Fortuna Fix Inc. (" Fortuna "), ... first to eliminate the need for embryonic and fetal stem ... neurodegenerative diseases. Fortuna announced today the ... Michael Fehlings , MD, PhD; Father Kevin FitzGerald , ... and Professor James Giordano , PhD. "We ...
Breaking Medicine Technology:
(Date:5/26/2017)... Fairfax, VA (PRWEB) , ... May 26, 2017 ... ... is pleased to announce a new educational seminar to focus on current legislative ... Regulatory News(LEARN) seminar will begin at 1 p.m. Sunday, Sept. 10, and will ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... copper, antimicrobial, mesh back 24/7 task chair specifically designed for clinical areas. Genie ... are thrilled to partner with Cupron® to provide customers with a game changing ...
(Date:5/26/2017)... , ... May 26, 2017 , ... Rob Lowe acts ... upcoming production of the series is on hiking in American. Viewers can reconnect with ... the great benefits of hiking. , Many consumers have looked for an inventive new ...
(Date:5/26/2017)... ... ... “Just What Happened in the Garden of Eden”: retells the stories of three Bible figures ... of published author, Penelope Colt, mother, trader, horse farmer, artist and a former GM journeyman. ... three. At six, they moved to Dayton, Ohio, where Penny graduated high school. ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, MD is dual board ... He is known for his distinguished expertise and experience in the diagnosis and treatment ... training in treating renovascular disease and aortic aneurysm . He is known for ...
Breaking Medicine News(10 mins):