- Delivery Method:
- Via Email
- Buzzagogo, LLC
85 Lakeview Drive
Nottingham, NH 03290
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
January 18, 2023
RE: # 639545
Dear Joyce Dales:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your product labeling, including on your website at the Internet address https://buzzagogo.com/, in August 2022 and has determined that you take orders there for the product “Allergy Bee Gone for Kids.” The 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.
In addition, FDA 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. This contamination is particularly concerning because “Allergy Bee Gone for Kids” is a nasal swab product and directed for use in young children.
The 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. Introducing or delivering this product for introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331.
Unapproved New Drugs
Examples of claims on your labeling that provide evidence of the intended uses of your “Allergy Bee Gone for Kids” product include, but may not be limited to, the following:
From the Allergy Bee Gone for Kids label and product page https://buzzagogo.com/collections/allergy-remedies/products/allergy-bee-gone-for-kids:
- “Relieves sinus congestion, sneezing, runny nose and post-nasal drip”
- “Nasal Swab Remedy”
- “Protect your Booger Biome”
From your product page https://buzzagogo.com/collections/allergy-remedies/products/allergy-bee-gone-for-kids:
- “WHAT IS IT: Allergy Bee Gone for Kids is a homeopathic remedy that you swab in your nose to fight nasal allergy symptoms, inflammation and to protect your Booger Biome . . .. The super honeys in Allergy Bee Gone for Kids are anti-inflammatory, prebiotic, probiotic.”
- “HOW IT WORKS: The science behind the Nasal Swab Method is that cold and flu viruses generally enter the body through our eyes, ears nose or throat . . .. Introducing our ingredients can help reduce the duration and severity of the illness.”
- “WHY MANUKA HONEY: . . . our super honey blend . . . is antimicrobial . . . probiotic, prebiotic . . .. It’s also infused with known cold-fighting homeopathic ingredients to alleviate active symptoms. All of these things combined are what make Cold Bee Gone for Kids so effective at fighting cold, flu and allergies.”
- “SUGGESTED USE: (Nasal Use Only) . . . helps alleviate common cold symptoms.”
The 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. Moreover, this product is also a “new drug,” as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No 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).
We note that “Allergy Bee Gone for Kids” is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.
FDA 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. The individual sample results from the tested batch spanned between 50 and 770 colony forming units (CFU)/mL for total aerobic microbial count, and between 5 and 70 CFU/mL for total yeast and mold counts. Therefore, this homeopathic drug product is adulterated under section 501(a)(1) of the FD&C Act, in that it consists in whole or in part of any filthy, putrid, or decomposed substance.
Microorganisms identified included Bacillus cereus, Bacillus amyloliquefaciens, Bacillus atrophaeus and others. Bacillus cereus produces a toxin and is pathogenic to humans. The labeling on your product indicates it may be used for children as young as 1 year old. The high bioburden and presence of objectionable microorganisms in conjunction with the route of administration poses a high risk of harm to patients, including children.
During the FDA teleconference on May 24, 2022, you stated that your drug products are manufactured by a contract manufacturer and that your drug products are tested before release by your contract manufacturer. During the call, you agreed to conduct a voluntary recall of the lot currently in U.S. distribution.
On June 7, 2022, you conducted a voluntary recall of lot 2006491 of Allergy Bee Gone For Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination, as noted on the following FDA website:
In response to this letter, provide:
- The name and address of the contract organizations you are currently using to manufacture and conduct microbiological analysis on Allergy Bee Gone For Kids Nasal Swab Remedy.
- A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.
- A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
- Complete investigations into all batches with potential objectionable microbial contamination (e.g., total counts, identification of bioburden to detect objectionable microbes). The investigations should detail your findings regarding the root causes of the contamination.
- Appropriate microbiological batch release specifications (e.g., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.
- All microbial test methods used to analyze each of your drug products.
- A summary of results from testing retain samples of all drug product batches within expected period of marketing. You should test all appropriate quality attributes including, but not limited to, microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.
Use of Contract Manufacturers
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act. For additional information regarding contract manufacturing, you may refer to FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address any violations may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration