A Los Angeles area supplement provider has been hit with an FDA warning letter for selling unapproved drugs for conditions ranging from kidney stones to stroke prevention.
A June 19 to June 24, 2015, inspection of the Dherbs Health Emporium’s facility and a subsequent review of the company’s website revealed that several of its products include labeling that would cause them to be drugs, the FDA says.
The letter also dings Dherbs for marketing products for conditions that cannot be self-diagnosed. The company, therefore, cannot write adequate directions for a layman to use the drugs safely, the FDA says.
The agency also cites Dherbs for packaging, preparing or holding dietary supplements in conditions that do not meet GMP regulations. Dherbs failed to furnish finished product specifications for each product manufactured and did not establish and follow written procedures for the responsibilities of the quality control operations.
In response to a Form 483, Dherbs told the FDA it would have written procedures implemented within two months; however, that response failed to include examples or evidence that it had executed these procedures.
Dherbs was unavailable for comment. Click here to read the warning letter.
Filed Under: Drug Discovery