Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your labeling establish that “Allergy Bee Gone for Kids” is an unapproved new drug under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355.
Passage 2FDA laboratory analysis determined that a sample of your “Allergy Bee Gone for Kids” product was contaminated with *bacillus sp*., including *B. cereus*, *B. amyloliquefaciens*, *B. atrophaeus*, and others.
Passage 3The results of the FDA laboratory testing of a batch of Allergy Bee Gone For Kids Nasal Swab Remedy demonstrate that this drug product is adulterated within the meaning of section 501(a)(1) of the FD&C Act , 21 U.S.C. 351(a)(1), in that it consists in whole or in part of any filthy, putrid, or decomposed substance.
Passage 4The above claims for “Allergy Bee Gone for Kids,” which is labeled as homeopathic, demonstrate that it is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.
Passage 5No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug marketed in violation of sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Passage 6FDA laboratory testing of a batch of Allergy Bee Gone For Kids Nasal Swab Remedy drug product (lot 2006491) found that it contained objectionable microbial contamination.
Passage 7The high bioburden and presence of objectionable microorganisms in conjunction with the route of administration poses a high risk of harm to patients, including children.