FDA WARNING_LETTER - Tattva's Herbs, LLC

The FDA issued a Warning Letter to Tattva's Herbs after reviewing their website, www.tattvasherbs.com. The agency determined that several products, including "Body Pure," "Evening Primrose Oil," and various Turmeric products, are promoted with therapeutic claims that cause them to be unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. These claims, such as treating and preventing cancer, anti-tumor properties, and reducing prostate cancer risk, establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease, violating 21 U.S.C. § 321(g)(1)(B). As these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under 21 U.S.C. § 321(p) and are illegally marketed without prior FDA approval as required by 21 U.S.C. § 355(a). Furthermore, the products are misbranded under 21 U.S.C. § 352(f)(1) because their labeling lacks adequate directions for use. The FDA noted that other unlawful claims and products were observed but too numerous to list. Tattva's Herbs must take prompt action to correct these violations and prevent recurrence, responding within fifteen working days with documentation of corrective actions. Failure to comply may result in enforcement actions, including product seizure and injunctions.