FDANews
The QMN Weekly Bulletin

Eidon Lands Warning Letter Over Marketing Claims

Feb. 12, 2016

A California supplement maker is in hot water after being accused of making drug-like claims about its products and relying on improper production methods.

In a Nov. 5, 2015 warning letter posted online in December, the FDA takes Eidon to task following the results of a Feb. 19 to March 5, 2015 inspection that allegedly uncovered unapproved promotional claims and violations of current good manufacturing practices.

The agency says Eidon promoted seven of its mineral-based supplements for the treatment or prevention of disease. These claims ran the gamut, from purportedly treating rheumatoid arthritis and lowering cholesterol levels to treating radiation sickness. A perusal of the company’s website shows that the cited claims appear to have been removed.

The letter also claims that an inspection turned up three production inadequacies, including concerns over its ID testing for zinc sulfate heptahydrate, which the company claims is conducted by a third party using liquid chromatography. According to the agency, it is not possible to conduct such a test on the material.

Another issue was a lack of established procedures to ensure proper packaging of supplement containers and closures. In response to a Form 483 that documented these observations, the company said it was developing written procedures to address the issue. However, the FDA says it has yet to receive the company’s written procedures for handling packing it has received.

Finally, the agency says the company failed to use unique lot and shipment numbers for tracking and tracing product shipments. Despite company assurances that employees have been retrained to assign such numbers, the agency says it hasn’t seen documentation backing up that claim.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.