Warning Letter and Recall of a homeopathic Medicine for Children

Recommendation

25-27 June 2024
Munich, Germany

European Microbiology Conference 2024

In January of this year, Buzzagogo, LLC in Nottingham received a Warning Letter from the FDA for their product "Allergy Bee Gone for Kids". According to the company's website, the product is suitable for treating runny noses and inflammatory symptoms associated with allergies. The product, according to the manufacturer's statement on its website, has the following uses and properties. "Allergy Bee Gone for Kids is a homeopathic remedy to be dabbed into the nose to combat nasal allergy symptoms and inflammation and to protect the booger biome.... The super honeys in Allergy Bee Gone for Kids are anti-inflammatory, prebiotic and probiotic. ....The introduction of our ingredients may help reduce the duration and severity of illness..... It is also infused with well-known homeopathic cold remedies to help relieve active symptoms. All of this combined makes Cold Bee Gone for Kids so effective in fighting colds, flu and allergies."

Lack of Approval

However, it appears from the statements on the label and those on the website that it is a drug subject to approval under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1). this includes items recognized in the official Homeopathic Pharmacopoeia of the United States (HPUS) or an amendment thereto. Homeopathic drugs are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from requirements relating to adulteration, misbranding, or approval. To date, however, no such approval exists.

Additional Findings

In addition, laboratory testing of one batch of the product also revealed contamination of microbiological origin that should not be underestimated. The results of the individual samples from the batch tested ranged from 50 to 770 colony forming units (CFU)/mL for the TAMC (total aerobic microbial count) and from 5 to 70 CFU/mL for the TYMC (total combined yeasts/molds count). The microorganisms found also included species such as Bacillus cereus, Bacillus amyloliquefaciens and Bacillus atrophaeus. The toxins produced by bacteria such as Bacillus cereus are pathogenic for humans, and especially when the product is intended for use by children over the age of one, the risk should not be underestimated, especially when administered through the nose.

Even the fact that the product is produced by a contract manufacturer does not release the company from the responsibility for the quality of the product, the FDA states in its letter. Already in June 2022 a recall of the batch for which the risk of contamination existed took place. Further details can be found in the FDA's Warning Letter.