The U.S. Food and Drug Administration issued a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products with claims to treat multiple conditions.
According to the regulator, Nutra Pharma was selling products that have not proven to be safe or effective and was breaking the law by selling such products.
In addition, the regulator noted that the unapproved products, which were labeled as homeopathic, claimed to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.
The March 19 warning letter was issued for Nutra Pharma's Nyloxin oral spray, Nyloxin topical gel, Nyloxin topical roll-on, Nyloxin topical roll-on ES, Nyloxin professional size pump topical gel and regular strength sample pack. FDA also said that the names of these products are similar to approved drugs, which may confuse the consumers.
The FDA categorizes claims to prevent, treat or cure health conditions for products that have not proven safety and efficacy for such uses as health fraud scams.
Nutra Pharma has 15 days to respond and if the company fails to correct violations, the FDA can take legal action without further notice, including, without limitation, seizure and injunction.