Bee Venom Powder

Bee venom is permitted in cosmetics under EU and US regulations but contains documented major allergens (phospholipase A₂, hyaluronidase, Api m 10) with high sensitization prevalence and anaphylaxis risk in atopic or previously sensitized individuals; apamin component is neurotoxic; therapeutic claims trigger drug classification.

FDA permits bee venom in cosmetics under FD&C Act provided product is safe under labeled conditions. Therapeutic claims (e.g., arthritis treatment) reclassify the product as a drug requiring FDA approval. No GRAS status (GRAS is food-only). FDA issued warning letter (Bee Delightful, Dec 2020) for unapproved drug claims. MoCRA PFAS/heavy metals provisions do not specifically target bee venom.