HDFrenchies LLC dba Bully Baum - 696351 - 11/12/2024

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WARNING LETTER

November 12, 2024

Ref: 696351

Dear Stephanie Schenk:

This letter concerns your firm’s marketing of unapproved new animal drugs, including Bully Baum No Seize, Can-B-Gone - Cancer Oil Extract, and Brain & Neurological for the treatment of diseases in animals, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) reviewed your website, https://bullybaum.com/, from October to November 2024, and has determined that you offer these products for sale there.

Based on our review of your website, your products are drugs under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Also, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they are not manufactured in a facility registered with the FDA and have not been drug listed with FDA as required by section 510 of the FD&C Act [21 USC §360]. Introducing or delivering these products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.

Examples of claims FDA observed on your website and product labeling that show the intended use of your products include the following:

From your home website titled “HDBullyBaum No Seize” at the URL https://bullybaum.com/products/no-seize:

• “… stops even the most violent seizures with very first dose.”
• “… anxiety, seizures…for ringworms…”
• “… Congestive heart failure (CHF), enlarged heart…, seizures, epilepsy… supports dogs having cancer…”
• “… treatment of respiratory diseases…, epilepsy, seizure disorders…”
• “… heart disease, diabetes, cancer…seizures, anemia, asthma…”
• “… helps in controlling the seizures and has nerve-protecting properties.”

From your home website titled “HDBullyBaum Can-B-Gone - Cancer Oil Extract” at the URL https://bullybaum.com/products/can-b-gone-cancer-remedy:

• “…the people of animals [sic] cured will come back …”
• “… heart disease, diabetes, cancer…, inhibit growth of lung, liver, cervical, breast, ovarian, and colorectal cancer cells…, seizures, anemia asthma…”
• “… can stop the growth of tumor cells and reduce the incidence of tumors…effective against cancer in blood system, lung, kidney, liver, prostate, breast, cervix, skin with much safety…”
• “… Antiviral activities of N. sativa against critical viral pathogens, focusing more on the SARS-CoV-2 virus…”
• “… fixes Cortisol issues…Inhibits: Cancer, Leishmaniasis…tumor growth…
• “… Stops: Cancer from growing, protects liver from lead toxicity…”
• “… Kills: Cancer and Tumors.”
• “… Congestive heart failure (CHF), enlarged heart…, seizures, epilepsy… dogs having cancer…”
• “… antioxidant, anti-inflammatory, antiviral, antibacterial, antifungal, wound healing and anticancer activities. Prevent cancer, slow the spread of cancer…”
• “… the cure for old age, breast cancer, uterine cancer, ovarian cancer…”

From your home website titled “HDBullyBaum BRAIN & NEUROLOGICAL” at the URL https://bullybaum.com/products/brain-neurological:

• “… Alzheimer's & Parkinson's disease, ADHD, Anxiety, Stress, Depression, Swelling in brain, Blood pressure, Liver function, Menopause, Memory, Sleep, Anti-Aging, Epilepsy, Hysteria, Insomnia, Convulsions.”
• “… anti-inflammatory and antioxidant effects…reduce seizure risk.”
• “… may have anticancer properties… kill aggressive brain tumor cells and inhibit the growth of breast, brain, and colon cancer cells in test-tube studies…may help reduce systemic swelling in the brain…”
• “… boosts dopamine level…helps treat neurodevelopmental disorders…”
• “… neuroprotective agent in the treatment of epilepsy, hysteria, insomnia, and convulsions…”

These products are new animal drugs under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. These products are not approved or index listed by FDA, and therefore, these products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

In addition, sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. Our review of your website indicates that you are offering for sale unapproved animal drugs in addition to those listed above. If FDA takes legal action, the action may address all your unapproved new animal drugs, not just those listed above. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA’s implementing regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing 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 (15) working days, state the reason for the delay and the time within which you will complete the correction. 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.

Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 696351” in the subject line of your email.

Sincerely,
/S/

Neal Bataller, ME, DVM
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine

cc: info@HDFrenchBulldogs.com