Companies warned for selling unapproved opioid cessation products using deceptive claims
The companies have 15 days to respond to the FDA and FTC.
FDA and the Federal Trade Commission (FTC) have posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.
Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act. Making unsubstantiated therapeutic claims is also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.
The FDA and FTC issued joint warning letters to 11 companies for their products:
The FTC sent four additional warning letters to other marketers of opioid cessation products.
The FDA and FTC have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address each agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
Related News
-
News Pharmaceutical Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain.
-
News Merck KGaA to buy US biotech SpringWorks for US$3.9 billion
The German multinational pharmaceutical company Merck KGaA have signed a deal to buy US biotech company SpringWorks Therapeutics at an equity value of US$3.9 billion in a move to add rare cancer therapeutics to their pipelines.
-
News Cassava Sciences halts Alzheimer's drug trial after limited progress
Cassava Sciences have drawn a close to their investigations and development of the drug simufilam, which they intended to be used for the treatment of Alzheimer’s disease.
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.
-
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries.
-
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.