FDA WARNING_LETTER - World Health Advanced Technologies Ltd - June 16, 2020

The FDA issued a Warning Letter to World Health Advanced Technologies on June 11, 2020, following a review of their website, enercel.com. The letter identifies several products, including "Enercel AM," "Enercel Forte," "Enercel Max," "Enercel Mist-Nasal," "Enercel Mist Nebulizer," "Enercel PM," "Vanicel," "Enercel Plus," and "Enercel Plus IM," as unapproved new drugs under section 505 of the FD&C Act.

The FDA states that introducing or delivering these products into interstate commerce violates section 301 of the FD&C Act. The agency expressed significant public health concerns, particularly regarding injectable products like "Enercel Plus" and "Enercel Plus IM," which bypass the body's defenses and carry risks of serious harm. "Enercel Plus" is further concerning due to its labeling of potentially toxic ingredients, such as "Lachesis Mutus (venum of the bushmaster snake)."

The products are marketed with claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions like tuberculosis, hepatitis, and lung cancer, which may lead consumers to forgo or delay effective medical treatments. Examples of these claims from the website include statements about treating multi-drug resistant tuberculosis, enhancing Natural Killer cells, improving quality of life for HIV patients, and miraculous healing of burns and resolution of Hepatitis C and cancer.