One of the most recent such warning letters was sent to a Vital Care Compounder, a compounding pharmacy in Hattiesburg, MS. Compounding pharmacies are pharmacies that make drugs for a specific patient or category of patients. Some examples include:
- A smaller, liquid dose of a drug that’s only available in adult-size tablets to give to a young child
- A dose of a drug that’s free of one or more ingredients to which a given consumer or set of consumers might be allergic.
In the warning letter dated Sept. 9 that was posted recently on FDA’s website the Agency alleged that the pharmacy was selling two sets of products, each of which was being marketed in a non compliant fashion. The pharmacy sells a number of supplements from some of the better known manufacturers focusing on the practitioner channel.
Two sets of supplements aimed at COVID-19
One product set was aimed at consumers worried about contracting COVID-19. The product set, called COVID PACK, was marketed with the following language:
“This supplement pack contains a 14 day supply of four physician recommended supplements for prophylaxis, treatment and recovery from the Covid-19 virus.”
The second set of products was aimed at consumers who had tested positive for the disease. Called COVID ‘POSITIVE’ PACK, the product was marketed with the following language:
“This kit contains the standard covid kit comprised of Vitamin D3, Vitamin C, Zinc and Melatonin but also includes a 14 day supply of Nattokinase 100mg . . . routinely prescribed for covid positive patients. Ideal to keep in the home for emergency use when a family member tests positive for the virus.”
No further information was available as to exactly which products that were contained within each product set. As of publication time, the portion of the company’s website where the products were sold, along with hand sanitizers, says, ‘Store closed,’ though the header of the page still says, ‘Covid-19 Supplement Packs.’
FDA and FTC have cooperated in sending out warning letters to firms and individuals because of what the agencies allege are non compliant disease claims that capitalize on the public’s concern about the pandemic. The agencies have put together a joint task force administered out of FDA’s Center for Drug Evaluation and Research (CDER). The task force maintains a list of noncompliant firms that is now up to 120 entries.
Doctors, pharmacists don’t get a pass on disease claims
Industry stakeholders have noted that some of the warning letters have been sent to health care practitioners who were marketing products to patients with non compliant claims. The practice has made some observers uneasy, as it seems to tread close to the line of protected speech between a doctor and a patient.
Now that issue extends to pharmacists as well. Attorney Ivan Wasserman, of the firm Amin Talati Wasserman, said health care providers and pharmacists don’t get a pass when it comes to COVID-19 claims. As there are at the moment no FDA-approved treatments for the disease, the Agency’s position has been that there is no way to make such a claim in a way that doesn’t violate the rules.
“As the spread of COVID-19 tragically shows no signs of slowing down, neither does FDA’s enforcement against products claiming to prevent or treat it. FDA is casting a wide net to catch these pernicious fish, and compounding pharmacies must also understand and follow the rules or risk being the catch of the day,” Wasserman said.
