Some people swear by the benefits of bee pollen, but if you sell products containing bee pollen you’d better not claim they can cure anything that ails you or else you’ll feel the wrath of the Food and Drug Administration (FDA).
Beulah T. Loudermilk, owner of J.L. Bee Products, LLC, in Raleigh, North Carolina, received a nasty note from the FDA pointing out that the products sold in her catalog – Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips – are classified as drugs under the Federal Food, Drug and Cosmetic Act because they are promoted as a cure, mitigation, treatment or disease preventative.
“Additionally, your products are not labeled as dietary supplements, and therefore do not meet the definition of a dietary supplement,” the letter went on to state.
J.L. Bee Products’ catalog claims that its bee pollen “has been shown to help with” conditions such as asthma, anorexia, constipation, diarrhea, prostatism and impotence, rheumatism and arthritis, colitis, depression, insomnia and arteriosclerosis, among other ailments. Bee propolis with rose hips claims to help with internal disease or dysfunction, colds and the flu, respiratory distress, mouth and ear infections, sunburns and ulcers, gum and tooth problems and anemia.
Other claims include “Today scientists confirm the outstanding antibiotic, anti-fungal, analgesic… and antiviral properties,” of bee propolis with rose hips.
“Your products are not generally recognized as safe and effective for the above referenced uses,” the agency warned the company.
FDA investigators also cited the company for not meeting current Good Manufacturing Practices, such as failing to establish written quality control procedures, and failing to keep proper records of its products. The company was given 15 working days to respond with specific steps it has taken to correct the violations listed and to prevent them from occurring again.