Warning Letter Sites Violations of Law
In early February of this year, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jackson Health & Wellness Clinic. The business was cited for several violations related to its marketing and administration of unapproved and misbranded drugs. The letter, dated February 3, 2023, detailed the FDA’s concerns, and requested immediate corrective action.
Marketing products with unapproved uses
According to the letter, the clinic marketed and administered various products, including peptides and stem cells, for unapproved uses such as anti-aging, hair growth, and weight loss. The FDA noted that these products are not approved for such uses and have not been demonstrated to be safe and effective for these purposes.
Misbranding drugs
In addition, the clinic was found to be misbranding drugs by failing to include adequate directions for use and by making false and misleading claims about the products’ safety and effectiveness. The FDA cited specific examples of misleading claims made on the clinic’s website, social media pages, and in patient testimonials.
Serious FD&C violations
The warning letter stated that these actions represent serious violations of the Federal Food, Drug, and Cosmetic Act, and that failure to promptly correct the violations may result in legal action, including seizure or injunction.
Summary
The FDA’s warning to Jackson Health & Wellness Clinic underscores the importance of compliance with regulatory requirements for marketing and administering drugs. Healthcare providers must ensure that all drugs are used for their approved purposes, and that marketing materials accurately reflect the drugs’ indications, benefits, and risks. Failure to do so not only puts patients at risk, but also exposes healthcare providers to legal and regulatory consequences.
Text of the warning letter
Click here to read a copy of FDA’s warning letter to Jackson Health & Wellness Clinic.