US FDA warns Hyderabad retailer over unapproved sexual enhancement pill sales

The United States Food and Drug Administration (FDA) has issued a warning letter to the Hyderabad-based online retailer Indiangoods.shop for marketing unapproved sexual enhancement supplements. In the letter dated June 17, the federal agency flagged the company for selling products with unauthorized health and performance claims, violating US drug safety laws.

According to the warning letter, the Hyderabad-based e-commerce platform has been marketing three specific products. These products are Moon Herbal Josh Awar Khas, Kapiva HimFoods Testo Capsules, and Patanjali Youvan Gold Plus Capsule. The FDA stated that these items were being promoted with claims that they can enhance sexual performance and address physical or sexual weakness.

The US regulatory authority explained that such marketing claims establish the products' intended use as drugs. However, none of these three products possess approved drug applications, making their sale under these claims a violation of federal law.

In the letter, the FDA stated that the products qualify as "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act. This classification is because the supplements are not generally recognised as safe and effective for their intended uses. The agency further noted that introducing or delivering these unapproved products into interstate commerce in the United States violates sections 301(d) and 505(a) of the Act.

The FDA's investigation found that the products were being marketed as drugs because of specific claims made on the company's website. These online claims indicated that the products were intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body.

Specifically, the agency pointed out that Moon Herbal Josh Awar Khas was promoted on the website with claims such as "for stamina and excitement" and "make love longer than ever." Additionally, Kapiva HimFoods Testo Capsules was marketed as a product that could "help increase testosterone levels."