Topic
fda
Regulations & Compliance Bombay HC Directs FDA to Pay Sweets Seller Rs 5 Lakh for Not Lifting Suspension
The Bombay High Court directed the Food and Drugs Administration (FDA) to pay Rs 5 lakh compensation to Pune-based M/s Gurunanak Dairy and Sweets for failing to revoke its food licence suspension despite 98% compliance. The court vacated the June 12 suspension order and allowed the retailer to restart its dairy and sweets business.
FDA Panel Endorses Unproven Peptides, Opening Door for Compounding Pharmacy Manufacturing
An FDA advisory panel voted 8-6 to recommend reclassifying three unproven peptides—BPC-157, KPV, and TB-500—allowing compounding pharmacies to produce them. A fourth peptide, MOTs-C, received a 7-5 vote in favor. The decision could reshape pharmaceutical manufacturing supply chains, as China and India are major suppliers of these peptides.
Regulations & Compliance FDA Denies Apologizing to Taylor Farms in Dispute Over Cyclospora Outbreak Recall
The FDA and Taylor Farms are in a public dispute over whether the agency apologized after a false positive test for cyclospora. The recall of iceberg lettuce from Central Mexico remains in effect, covering 27 states and products sold to Taco Bell and Walmart. Thousands have been sickened since May.
Regulations & Compliance FDA Authorizes ZYN Nicotine Pouches as Lower-Risk Alternative to Cigarettes, With Caveats
On June 30, the FDA authorized 20 ZYN nicotine pouch products to carry a modified risk claim, stating they are a lower-risk alternative to cigarettes for adults who completely switch. The decision is based on toxicology data and public health modeling but comes with caveats: it applies only to specific products and only to full switchers. Global sales of nicotine pouches reached 23.4 billion units in 2024, a >50% increase from the previous year, according to the WHO.