FDA WARNING_LETTER - Chambers' Apothecary - November 17, 2022

The FDA issued a Warning Letter to Mr. Robert Norris regarding products sold on www.chambersapothecary.com, specifically Blood Pressure Support and CoEnzyme Q10. An FDA review in October 2022 found that claims on the website establish these products as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease cure, mitigation, treatment, or prevention.

The products are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they fail to bear adequate directions for their intended uses. As they are intended for diseases not amenable to self-diagnosis or treatment, adequate directions for layperson use cannot be provided, making them misbranded. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act.

The letter requires a written response within fifteen working days detailing specific corrective actions taken, an explanation of steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure and injunction