FDA Floats Broader Pathway For Nicotine Replacement Therapies
This article was originally published in The Pink Sheet Daily
FDA’s report to Congress on tobacco abstinence therapy points toward a “comprehensive strategy” for tobacco and nicotine product regulation, incorporating the work of the drug, device and tobacco centers. Some smoking cessation experts say changes are overdue.
You may also be interested in...
The U.K. pharma regulator requires all electronic cigarettes to be licensed as nonprescription medicines beginning in 2016, noting concerns about product quality. Meanwhile, FDA considers allowing e-cigarettes to be marketed as nicotine replacement therapy on a case-by-case basis.
FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.
While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.