The Food and Drug Administration (FDA) issued a warning letter to NutraPharma, for selling false and misleading products that claim to treat addiction and chronic pain. The products are sold via the website nyloxin.com.
The Agency has given the Company 15 working days to respond with their plans for addressing the violations; failure to do so may lead to legal action, including limitation, seizure, and injunction.
Specifically, the Agency pointed to the homeopathic products “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”, which claim to treat a range of conditions from rheumatoid arthritis to various cancer pain. The similarity in name to the drug naloxone could also confuse consumers.
These products have not been approved by the FDA and therefore violate the law (The Food Drug & Cosmetic Act) making them unsafe for use. Further, the omission of ‘Rx only’ from the labels makes them misbranded.
The Agency also highlighted the repeated use of the FDA logo on nyloxin.com, accompanied on the ‘FDA Registered’ text on the ‘shopping cart’ page. This is a false claim as the FDA has no record of a drug establishment registration associated with NutraPharma Co., and the Agency does not register drugs.
The FDA’s efforts to support alternatives to opioid analgesics with medication-assisted treatments could be undermined by the sale of such products with unsubstantiated claims. An FDA statement outlined how “using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery and put them at greater risk of death.”
For more information visit FDA.gov.
This article originally appeared on MPR