Beehive Botanicals, Inc. 02-Mar-07

March 2, 2007
WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 07-15

Linda Graham
President and Owner
Beehive Botanicals, lnc.
16297 West Nursery Road
Hayward, Wisconsin 54843-7i38

Dear Ms. Graham:

This letter is in reference to your firm’s manufacture and distribution of various products identified during our inspection conducted on November 14 and 15, 2006, at your facility located at 16297 West Nursery Road, Hayward, Wisconsin. This inspection was conducted to determine your firm’s compliance with the Federal Food, Drug and Cosmetic Act {the Act) and applicable implementing regulations contained within Title 21 of the Code of Federal Regulations (21 CFR). In addition, the FDA reviewed your web site at http://www.beehivebotanicals.com. The above-referenced inspection and our review of your web site revealed serious violations of the Act in the labeling of your Standardized Bee Propolis Dietary Supplement, PropolPom™ Bee Propolis Pomegranate Dietary Supplement, Bee Pollen Whole Grain Dietary Supplement (capsules, tablets and granules), Royal Jelly Dietary Supplement (1000 mg), Propolis & Herb Throat Spray, Propol-Guard Lip Balm, Therapeutic Derma Cream and Propolis 50% and 65% Tinctures. You can find the Act and implementing regulations through links on FDA’s Internet home page at http://www.fda.gov.¹

New Drugs

Examples of claims in your product labeling “Discover the Power of the Hive” (product catalog) and on your web site promote your specific products with the following claims:

• Bee Pollen Whole Grain (capsules, tablets, granules): “It also destroys harmful bacteria in the intestines . . . .”
• Standardized Bee Propolis Dietary Supplement: “Propolis is proven to have distinct antibacterial, antiviral and antifungal properties.”
• PropolPom™ Bee Propolis Pomegranate Dietary Supplement: “Propolis is proven to have distinct antibacterial, antiviral and antifungal properties.”
• Propolis & Herb Throat Spray: “A quick, effective way to soothe sore, dry scratchy throats.”
• Propol-Guard Lip Balm:°Contains the healing power of Propolis and Vitamin E ….”
• Therapeutic Derma Cream: “….germ-killing properties of Propolis.. .this remarkable cream uses propolis to help heal irritations, rashes and other skin problems….Promotes rapid healing.. .Helps irritation, rashes and other skin eruptions ….”
• Propolis 50% and 65% Tincture, 1 ounce: “Propolis is proven to have antibiotic, antiviral and antifungal properties. Effective for external problems such as skin eruptions, burns, cuts, and slow healing sores. . . “
• For all Propolis containing products:
  • “Propolis is extremely high in bioflavonoid content. Flavonoids are well-known plant compounds that have….antibacterial, antifungal, antiviral and anti-inflammatory properties.”
  • “Other properties, of Propolis include acting as a iocal anesthetic …. healing gastric ulcers…”
  • “Propolis has been shown to have antibacterial, antiviral and antifungal properties.”

In “Product Info” and Botanicals News articles on your web site, www.beehivebotanicals.com:

Propolis Benefit: “May help alleviate several infectious illnesses such as . . .influenza, bacterial infections, pharyngitis and other throat infections…and even allergies.” “It has also been known to help with common maladies such as ulcers, hypertension, periodontal problems, tumors, hyper and hypotension, nerve illnesses, cholesterol leveling, thyroid, and glandular disorders!”

Royai Jelly – Hiveful Of Healing: “Royal jelly is known to aid in liver disease, pancreatitis, insomnia, stomach ulcers, kidney disease, bone fractures and skin disorders:” “[S]uccessfully combats whooping cough, especially in children.” “Benefits can also be obtained in cases of bronchitis, migraine. . . .” “Royal jelly is both an antibiotic and bactericide, effective in treating virus-infected patients – particularly with various types of flu and herpes virus.” “[R]oyal jelly is effective in relieving symptoms of arthritis. . .” “[E]ffective in managing eczema, neurodermatitis and impetigo.. . .” “For example, one of its little-known benefits is its ability to help relieve emotional disorders such as anxiety, depression, shock and senility, as well as chronic insomnia.”

Bee Propolis Can Help Treat Various Diseases: “Propolis has proved, effective in helping to deal with a wide variety of infections and illnesses,including ulcers. ..hypertension, pharyngitis, and periodontal problems.” “[P]ropolis has antiproteolytic, bactericidal, and bacteriostatic action that is unparalled among natural substances.” “[B]enefit manifests itself in lowering of blood pressure, 3) in about half of the cases, there was also a lowering of cholesterol level.” “[U]sed Propolis in the treatment of patients with malignant tumors (usually on the skin) . .. .” “Propolis has also been used successfully against influenza in Russia and Yugoslavia.”

What Are Bioflavonoids?: “Bioflavonoids strengthen capillary walls, preventing capillary darnage which leads to bleeding disorders including . . .varicose veins, hemorrhages. . . .” “Antibiotic-like activity.” “[M]ay lower cholesterol. [P]otent anti-inflammatory agents.” “[M]ay prove useful in the treatment of arthritis.” “Anti-cataract.”

Propolis: “Propolis has been used in the treatment of advanced stages of pulmonary tuberculosis. . . .” “[A]djuvant therapy in the treatment of cases of a non-specific bronchitis where a conventional antibiotic has failed.”

Propolis – Recognized As A Powerful, All Natural Antibiotic: “[P]ropolis or “Russian. Penicillin” is known in countries outside the United States as a powerful, all-natural anti-biotic.” “[I]n capsule form, where it can be taken as a supplement aiding against bacterial infections. . .even found in lozenges, chewing gum and toothpastes due to its healing effects for sore throat and swollen gums.”

Bee Pollen: “[P]ollen is also very rich in, Rutine (Vitamin P) . . . .” “Rutine reinforces, enlarges capillaries, veins, and arteries, and helps and reverses hardening of the arteries. . . .” “[P]ollen is extremely valuable in cases of pernicious anemia. . . .”

Factual Recapitulation, Gleanings And Observatioas On Royal Jelly: “[H[elps relieve and often eliminate pain of arthritis,. . .helps nervous and vascular troubles such as Parkinson’s Disease, . . .is beneficial in nervous disorders, such as cerebrai neuritis, and nervous debility, diabetes, asthma, sterility in women, impotence in men, and degenerative diseases.” “[R]oyal Jelly which has undergone laboratory tests been found to be reacting favorably against the malignant growth of tissue… .”

These claims cause your products to be drugs, as defined in section 201{g)(1)(B) of the Act [21 U.S.C. 321(a)] because they establish that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Further insofar as your products are intended to be used in some manner other than ingestion, such as your sprays, balms, and creams, they are drugs under 201(g)(1)(C) even if they are intended only to affect the structure or function of the body because they do not meet the definition of food or dietary supplement under sections 201(f) and 201(ff)(2)(A) of the Act. Because your products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act. Under section 505 of the Act (21 U.S.C. 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Unapproved Medical Devices

Under section 201(h) of the Act [21 U.S.C. 321(h)], Propolis 50% Tincture, Propolis 65% Tincture, and Propolis Extract Alcohol Free are devices. Your web site represents that these products may be used to treat “skin eruptions, burns, cuts, and slow healing sores.” These representations make clear that these products are intended for use in the diagnosis of disease or in other conditions or in the cure, mitigation, treatment, or prevention of disease or are intended to affect the structure or function of the body. Because they do not appear to achieve their primary intended purpose through chemical action, they are devices, rather than drugs. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This statutory requirement helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering these devices for sale, which is a violation of the law. Specifically, Propolis% 50% Tincture, Propolis 65% Tincture, and Propolis Extract Alcohol Free are adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. 351(f)(1)(B)] because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. 360e(a)], or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. 360j(g)]. These devices are also misbranded under section 502(o) of the Act [21 U.S.C. 352(o)] because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act [21 U.S.C. 360(k)]. For a device requiring premarket approval, the notification required by section 510(k) of the Act [21 U.S.C. 360{k)] is deemed satisfied when a PMA is pending before the agency [2 i CFR 807.81(b)]. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html². The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Our records do not show that your establishment in Haywood, Wisconsin, is registered with the FDA’s Center for Devices and Radiological Health on the form FDA 2891, and your devices, Propolis 50% Tincture, Propolis 65% Tincture, and Propolis Extract Alcohol Free, are listed on the form FDA 2892. Failure to register your establishment as required by section 510 of the Act (21 U.S.C. 360), and list these devices, as required by section 510(j) of the Act [21 U.S.C. 360(j)] causes your devices to further be misbranded within the meaning of section 502(0) of the Ac [21 U.S.C. 352(0)].

Misbranded Food (Dietary Supplement)

In addition, even if your Standardized Bee Propolis Dietary Supplement (500 mg) and Royal Jelly Dietary Supplement (1000 mg) were not drugs, they would still be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a) 1)]. Your Standardized Bee Propolis product is labeled to contain 500 mg; however, the Supplement Facts panel identifies the actual amount to be 250 mg. Your Royal Jelly product states “1000 mg” on the principal display panel, though in the Supplement Facts panel, the serving size of 1 capsule contains 334 mg.

This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all labeling for products distributed by your firm are in compliance with the Act and its implementing regulations. FDA regulations are available on FDA’s web site at www.fda.gov³, We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides or the seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

This letter is not intended to be an all-inclusive review of the products your firm markets. You are responsible for ensuring that your facility operates in compliance with the Act and its implementing regulations.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.

Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District
TSW/ccl

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1 Insofar as these products are intended to be taken internally or achieve their primary intended purposes through chemical action within or on the body, they may also be, or contain, drugs requiring approval under section 505 of the Act before they may be marketed