FDA WARNING_LETTER - CHS - January 21, 2025

The FDA issued a Warning Letter to www.weightcrunchshop.com on January 13, 2025, for unlawfully selling unapproved and misbranded drugs to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the website introduces unapproved new drugs, including "Orsema 0.25 mg" and "Orsema 0.50 mg" injectable semaglutide products, which lack FDA approval despite being marketed for type 2 diabetes and cardiovascular risk reduction. These products are considered new drugs under section 201(p) and their introduction into interstate commerce violates sections 301(d) and 505(a).

Furthermore, the website sells misbranded drugs. "Orsema" products are misbranded under section 502(f)(1) because they are prescription drugs requiring professional supervision, and their labeling lacks adequate directions for layperson use. The website also offers prescription drugs like "Ozempic 0.25 mg," "Ozempic 0.5 mg," "Ozempic 1 mg," and oxycodone 15 mg and 30