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Food and Drug Administration (FDA)

The Cost of GMP Compliance

The costs companies incur to become compliant with dietary supplement GMPs are numerous and variable, covering everything from increased testing, record-keeping and quality control processes, as well as any additional facility improvements, personnel, training and ...More
February 8, 2012 By Steve Myers
Posted in Articles
Broken Heart Supplement May Cause Legal Heartburn

Lonely hearts may turn to a new dietary supplement to get over a broken heart, but, a review of the ingredients list and the website copy shows this supplement may be running into legal issues. ...More
February 7, 2012 By Sandy Almendarez
Posted in Blog
ABC Article Outlines Supplement Regulation Myths

HerbalGram features an in-depth article written by health policy, research and regulatory experts, who clarify the broad regulation of supplements and dispel popular myths. ...More
February 6, 2012
Posted in News
Basic GMP Points to Consider

Many well-intentioned companies have been left confused and puzzled by GMPs (good manufacturing practices), especially when they receive an unexpected 483 or warning letter from FDA. ...More
February 2, 2012 By Robin Koon
Posted in Articles, Contract Manufacturing
Trade Show Promo Triggers FDA Warning Letter

As companies get ready for the trade show season, they need to make sure all product literature is checked twice by their legal experts, as a recent warning letter shows FDA has no qualms about issuing warning letters based on materials picked up at a booth. ...More
January 31, 2012
Posted in News
NEJM Editorial: DSHEA too Lenient

Pieter A. Cohen, M.D., took a jab at the dietary supplement industry, saying FDA has not enforced the new dietary ingredient (NDI) provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA), in a recent New England Journal of Medicine perspective (DOI ...More
January 26, 2012
Posted in News
Mounting Costs?

Complying with dietary supplement GMPs potentially presents companies with escalating costs for testing, personnel, equipment and third party services. ...More
January 26, 2012
Posted in Blog
NPF Refers 22 Supplement Advertisers to FTC

The Natural Products Foundation delivered documentation to FTC showing 22 companies are not compliant with regulations governing dietary supplement advertising. ...More
January 23, 2012
Posted in News
Company Says It Sells 'Legal Anabolic Steroid'

Zupplements.com is now selling a "new legal anabolic steroid" supplement, according to a press release posted today. I call shenanigans; there's no way this is legal. ...More
January 20, 2012 By Sandy Almendarez
Posted in Blog, Sports Nutrition
Axis Labs Gets Probation, Fines in Steroid Case

Axis Labs LLC was sentenced to a one-year probation, fined $50,000 and ordered to forfeit $107,000 in connection to a mail fraud case. Federal prosecutors accused the company of distributing anabolic steroids masquerading as a weight-loss supplement. ...More
January 20, 2012
Posted in News, Sports Nutrition