FDA WARNING_LETTER - Pharmline, Inc. - February 03, 2010

The FDA inspected Pharmline, Inc. in Florida, NY, from January 14 to February 3, 2010, and found serious violations of the Federal Food, Drug, and Cosmetic Act. The inspection revealed that Pharmline received both gamma-treated and non-gamma-treated spirulina powder, and sent a lot of non-gamma-treated spirulina for gamma irradiation. This spirulina powder is adulterated under section 402(a)(7) of the Act because it was intentionally subjected to radiation without an FDA regulation or exemption in effect pursuant to section 409 of the Act (21 CFR 179.26).

Additionally, Pharmline's Saw Palmetto Extract 30% product is misbranded under section 403(i)(2) of the Act because its label fails to declare all ingredients, specifically dicalcium phosphate dihydrate, sorbitol, maltodextrin, and calcium silicate, as required by 21 CFR 101.4(a)(1).

The FDA acknowledged Pharmline's February 18, 2010, response to the FDA-483, emphasizing that no FDA regulation authorizes irradiation for dietary ingredients like vitamins, minerals, or botanicals due to concerns about nutrient effects, radiolytic byproducts, and microbiological profiles. The letter also noted that if manufacturing dietary supplements, Pharmline is subject to 21