Hevert Pharmaceuticals LLC USA – FDA Warning Letter, Jun 16, 2020

The FDA issued a Warning Letter to Hevert regarding its injectable products: "Arnica," "Calmvalera comp.," "Gelsemium comp.," "Hepar comp.," and "Lymphaden comp." The FDA reviewed product labeling, including labels and the hevert.com website.

The core violation is that these injectable products are unapproved new drugs under Section 505 of the FD&C Act, 21 U.S.C. 355. Introducing or delivering them into interstate commerce violates Section 301 of the FD&C Act, 21 U.S.C. 331.

The FDA highlighted public health concerns due to the injectable nature of the products, which bypass the body's defenses and pose risks of serious harm. Furthermore, some products are labeled to contain potentially toxic ingredients like "nux vomica" (strychnine) and "plumbum aceticum" (lead), increasing the risk.

Product claims, such as "Arnica" for muscle pain, "Calmvalera comp." for nervous disorders, "Gelsemium comp." for nerve conditions, "Hepar comp." for liver disorders, and "Lymphaden comp." for lymphatic issues, establish them as drugs intended to treat or affect body function. They are considered "new drugs" because they are not generally recognized as safe and effective. No approved application under Section 505 of the FD&C