FDA WARNING_LETTER - www.dashpct.com - April 30, 2024

The FDA issued a Warning Letter to www.dashpct.com on April 24, 2024, for unlawfully selling unapproved and misbranded drugs, specifically semaglutide products, to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The website offers "Rybelsus 14mg" and "Rybelsus 7mg" semaglutide tablets, which are unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act. No FDA-approved applications exist for these specific products offered by www.dashpct.com, despite the existence of approved semaglutide products like Rybelsus, Ozempic, and Wegovy in the U.S. market, which are prescription-only and carry a boxed warning for thyroid C-cell tumors.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision.

The FDA requires www.dashpct.com to cease offering these unapproved and mis