The FDA reiterated a similar statement it made in December 2010, this time noting it had found almost 300 “fraudulent products” usually in the weight loss, sexual enhancement, and bodybuilding sectors containing FDA-approved drugs or their analogs or non-approved compounds such as synthetic steroids.
“These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements,” said Michael Levy, the FDA’s director in its Division of New Drugs and Labeling Compliance.
“Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”
FDA said adverse event reports (AERs) for such products included stroke, liver injury, kidney failure, heart palpitations, and death.
FDA noted it had, "worked with industry" to recall:
- more than 40 products marketed for weight loss
- more than 70 products marketed for sexual enhancement
- more than 80 products marketed for body building
A link to the statement can be found here.
FDA warns Gaspari about adverse event violations
New Jersey-based body building dietary supplements manufacturer Gaspari Nutrition is the latest firm to be in breach of Good Manufacturing Practice (GMP) regulations after inspections in 2010 revealed AER breaches.
The FDA ‘483' inspections that occurred over a five week period between September 27 - November 1, 2010, found the maker of PlasmaJet and SuperPump products did not follow its own AER procedures in regard to seven separate complaints.
For those two products, the FDA said the company did not perform analysis of the complaints it classified as “minor discomfort”.
For a product called Mitotropin, complaints were classified as, "Serious Personal Injury Claims”, but Gaspari did not have them, “referred to the Senior Manager of Distributor Services or have the Senior Manager interview the complainants, as called for in your firm's written procedures.”
There was also a "Serious Personal Injury" complaint for SuperPump.
Gaspari responded to the FDA in November, 2010, saying it was rectifying the issues, but the FDA said the problems had not been resolved and added that it would be evaluating, “whether your firm has established and followed written procedures for reviewing product complaints during our next inspection.”
The AERs included sores inside a consumer's mouth, as well as, "chest pain and abnormal kidney levels" after product consumption.
Gaspari also, “did not investigate the complaint of a consumer who contacted your firm regarding having bloody stools and excessive amounts of red color in their toilet water following consumption of your SuperPump dietary supplement product.”
A Gaspari spokesperson said the company had no comment on the letter.
The SuperPump250 Supplement Facts Panel can be found here.