FDA Warning Letters: May 2023 Edition
Misbranded drugs, unapproved drugs, and companies who don’t know that ophthalmic drugs should be manufactured in a sterile environment…
Stephanie Sutton | | 4 min read | Opinion
Warning Letters from the FDA play a crucial role in maintaining companies’ adherence to regulations and protecting the well-being of patients. Though some Warning Letters are prompted by honest mistakes (or lack of common sense), they can also work as an impetus for much needed improvement at a company. At other times, honesty is not in plain sight. Here’s a selection of Warning Letters recently sent to companies caught red-handed.
Back in February, the FDA issued an advisory to consumers regarding PrimeZen Black 60000 – a sexual enhancement dietary supplement being sold on various websites, including Volt Candy. Subsequent analysis by the FDA revealed that the product contained undeclared ingredients: sildenafil and tadalafil (the APIs in Viagra and Cialis). At the request of the FDA, a voluntary recall was initiated by the Volt Candy website. Now, the FDA has followed up with a Warning Letter to the company Tager Online, which runs the Volt Candy website.
Tager Online is not the manufacturer of the product, but it should have been aware that it was selling potentially unapproved male enhancement drugs. The FDA also identified that the Volt Candy website has various products for sale “that resemble products in previous FDA warnings about undeclared drug ingredients.”
A slap on the nose
“NOSE SLAP! THE WAKE UP STICK . . . SMELLING SALTS INFUSED W/ESSENTIAL OILS . . .”
“What is Nose Slap?. . . Nose Slap is Maximum Strength Smelling Salts with Essential Oils…Nose Slap is a mixture of sodium carbonate, ammonium chloride, and peppermint essential oil . . .”
The description taken by the FDA from the Nose Slap website clearly markets the OTC product “Nose Slap” as a reflex stimulant containing ammonium chloride, sodium carbonate, and essential oil, which makes the product an unapproved new drug as far as the FDA is concerned. A Warning Letter has been sent to Nose Slap, with the FDA also noting that it is “not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that ‘NOSE SLAP’ and ‘SOUL SLAP’ are GRASE [generally regarded as safe and effective] for use under the conditions prescribed, recommended, or suggested in their labeling.”
After analyzing a sample of Alfia Weight Loss Capsules (which were advertised as “100% natural”), the FDA found undeclared sibutramine – the API in Meridia, which was approved in 1997 for treating obesity before being withdrawn in 2010 due to the increased risk of heart attack and stroke. A Warning Letter has been sent to the company iSlim.
Zermat International – a company based in Mexico – received a Warning Letter for significant cGMP manufacturing violations. The Warning Letter follows a Form 483 issued in 2022, to which the company did respond, but the FDA found the response inadequate.
Brace yourself, there’s a lot to unpack in this Warning Letter. Firstly, the company was not investigating out-of-specification (OOS) results. Drug products that were OOS were released and distributed, with the company admitting that it did not have a procedure to handle OOS results. The company was also pulled up for not having stability data, particularly for long-term stability, and for failing to validate certain manufacturing processes. In the letter, the FDA said “Your firm lacks an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.”
Overall, the FDA described the company’s quality systems as “inadequate” and has recommended that they seek out a cGMP consultant.
“Contaminated with filth”
During an inspection of Pharmedica (Arizona), the FDA noted “that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.” The facility was in a “state of disrepair” and lacked ISO classified areas, including ISO 5 for sterile drug product manufacturing.
The company manufactures an OTC ophthalmic product, but was “unaware that ophthalmic drug products are required to be sterile.” The company has issued a recall and has said it will cease production of all drugs at the facility.
We think that’s for the best – especially amidst a spike in Pseudomonas aeruginosa infections…