Bee Healthy Farms LLC MARCS-CMS 644012 — May 03, 2023

WARNING LETTER

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• Delivery Method: VIA UPS
• Product: Food & Beverages

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• Recipient: Jean F. Lariviere; Registered Agent; Bee Healthy Farms LLC; 945 S. Old Orchard Ave.; Springfield, MO 65802; United States

• Issuing Office: Division of Human and Animal Food Operations West II ; United States

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May 3, 2023

Reference CMS # 644012

WARNING LETTER

Dear Mr. Lariviere:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.beehealthyfarms.com in September and October 2022 and again in March and April 2023, and has determined that you take orders there for the products Bee Healthy Farms Bee Propolis Capsules (1000 mg), Bee Healthy Farms Royal Jelly Capsules, Bee Healthy Farms Organic Clover Honey Sticks, Propolis Mint Chewing Gum, Kontak Organic Children’s Propolis Extract 20%, and Propolit Propol Caps. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims on your website www.beehealthyfarms.com that provide evidence your products are intended for use as drugs include:

• Kontak – Organic Children’s Propolis Extract 20%

o “We use it frequently to treat early signs of a sore throat or even mouth ulcers.”
o “Filled with numerous flavonoids, Propolis has been proven to possess many important properties, including

antibacterial
antiviral
antitumor
anti-inflammatory”

o “In fact, recent research has found Propolis enhances the effects of prescribed antibiotics, protected against negative effects of vaccines and sped up the healing of bone fractures. It’s even been found to increase the success of chemotherapy!”
o “Our Organic Propolis is …documented for having anti-fungal, antiviral, and antitumor properties, thanks to such flavonoids…”
o “Galangin, a well-known bioflavonoid found in Propolis…is specifically documented for its effectiveness in the following studies:

wound healing
antimicrobial activity…
antimicrobial and antimycotic…”

• Propolit Propol Caps:

o “Propolis is a resinous substance with recognized beneficial properties in the case of intestinal peristalsis, (with the improvement of the secretion of gastricjuices) and for the prevention of flu and catarrhal forms of the respiratory tract.”

• Bee Healthy Farms Bee Propolis Capsules (1000mg):

o “Filled with numerous flavonoids, Propolis has proven to possess many important properties, including

antibacterial
antiviral
antitumoral
antifungal
anti-inflammatory
antiseptic
antiparasitic
anti-diabetic”

o “…Propolis…sped up the healing bone fractures. It’s even been found to increase the success of chemotherapy!”
o “Our propolis is certified to contain active flavonoids, documented for having anti-fungal, antiviral and antitumor properties…”

• Bee Healthy Farms Royal Jelly Capsules:

o “It is specifically recommended for treatment of hypertension, hyperlipidemia and inflammation, and is being studied for a possible anti-tumor effect as well as a treatment for male infertility.”
o “[O]ur capsules…guaranteed to contain at least 6% HDA(10-hydroxy-2-decenoic acid)an antimicrobial…HDA has been proven in new research to reduce bacterial growth in the mouth, which causes plaque and bacterial infections.”

• Bee Healthy Farms Organic Clover Honey Sticks:

o “Benefits of Honey:…

Relieves coughing
Aids sore…throats
Antiseptic
Heals wounds”

• Propolis Mint Chewing Gum:

o “Propolis has antibacterial and anti-inflammatory properties…”
o “Propolis flavonoid properties include:

antibacterial
antiviral
antitumor
antiseptic
anti-depressant
anti-inflammatory”

On the blog page of your website https://www.beehealthyfarms.blogspot.com/
You make the following claims about studies on propolis, an ingredient in Bee Healthy Farms Bee Propolis Capsules, Propolis Mint Chewing Gum, Kontak Organic Children’s Propolis Extract 20%, and Propolit Propol Caps:

“Propolis Alleviates Depressive Symptoms”.

“Propolis Spray Improves Response to Bacterial, Viral Respiratory Infections”

“Propolis: A Natural Healer of Gastrointestinal Diseases”

“Propolis: Potential Solution to Gluten-induced Celiac Disease”.

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. §321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Bee Healthy Farms Bee Propolis Capsules (1000mg), Bee Healthy Farms Royal Jelly Capsules, Propolis Mint Chewing Gum, Kontak Organic Children’s Propolis Extract 20%, and Propolit Propol Caps are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Bee Healthy Farms Bee Propolis Capsules (1000mg), Bee Healthy Farms Royal Jelly Capsules, Propolis Mint Chewing Gum. Kontak Organic Children’s Propolis Extract 20%, and Propolit Propol Caps fail to bear adequate directions for their intended use and therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. §331(a)].

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 this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 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 actions within 15 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 Act, include your reasoning and any supporting information for our consideration.

Your written response should be directed to the Food and Drug Administration, attention to: Dr. LaTonya M. Mitchell, Ph.D., Program Division Director, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. You may email a copy of your response to email address: orahafwest2firmresponses@fda.hhs.gov.

If you have any questions regarding this letter, please contact, Kara L. Roden, Compliance Officer, at telephone number (913) 495-5121 or via email at Kara.Roden@fda.hhs.gov.

Sincerely,
/S/

Dr. LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods - West Division 2