Hyderabad: The US Food and Drug Administration (FDA) has issued a warning to Hyderabad-based Indiangoods.shop for marketing three products – Moon Herbal Josh Awar Khas, Kapiva HimFoods Testo Capsules and Patanjali Youvan Gold Plus Capsule – with claims that they can enhance sexual performance and address physical or sexual weakness.According to the FDA, such claims establish the products’ intended use as drugs, even though they do not have approved drug applications.In a letter dated June 17, the FDA stated that the products qualify as “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act because they are not generally recognised as safe and effective for their intended uses. The agency said that introducing or delivering such unapproved products into interstate commerce in the United States violates sections 301(d) and 505(a) of the Act.The FDA said the products were being marketed as drugs because claims on the company’s website indicated they were intended to diagnose, cure, mitigate, treat or prevent disease, or affect the structure or function of the body.According to the agency, Moon Herbal Josh Awar Khas was promoted with claims such as “for stamina and excitement” and “make love longer than ever.” Kapiva HimFoods Testo Capsules was marketed as a product that could “help increase testosterone levels.”Patanjali Youvan Gold Plus Capsule was described on the website as “an authentic powder booster Ayurvedic medicine useful in physical & sexual weakness.”The website further claimed that it “improves libido, vigour and vitality, sexual power” and “keeps you always healthy, energetic & gives you total satisfaction of married life”.The FDA said these representations demonstrated that the products were being promoted for health and performance-related purposes. As they are not generally recognised as safe and effective for such uses, the agency classified them as unapproved new drugs.According to the letter, Indiangoods.shop, which markets the products online, is registered at Kalyan Nagar in Yousufguda.The FDA directed the company to take prompt corrective action and submit a written response within 15 business days detailing the steps taken to address the cited violations.The response must also explain the measures implemented to prevent similar violations in the future. The agency cautioned that failure to adequately address the issues could result in enforcement action without further notice, including product seizure or an injunction.
