Inspections, Compliance, Enforcement, and Criminal Investigations
Sleeping Bear Apiaries 22-Oct-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
October 22, 2008
Kirk D. Jones, President
Sleeping Bear Apiaries
971 S. Pioneer Rd.
Beulah, MI 49617-9778
Dear Mr. Jones:
The Food and Drug Administration (FDA) inspected your firm on June 2-3, 2008. During the inspection, labels for your Michigan Montmorency 100% Pure Cherry Juice Super Concentrate and Real Raw Honey products were collected for further review. We have also reviewed the labeling of your Michigan Montmorency 100% Pure Cherry Juice Super Concentrate and Real Raw Honey on your web site at www.sleepinp bearfarms.com. Our review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of these products. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [section 201(g)(1)(B) of the Act, 21 U.S.C. 321(g)(1)(B)]. The labeling for your products bears the following claims:
Michigan Montmorency 100% Pure Cherry Juice Super Concentrate
•"New university research studies have discovered that tart Montmorency cherries are rich in
antioxidants that may help fight cancer and heart disease. Tart cherry juice contains compounds that may help relieve the pain of arthritis, gout, and even headaches."
•"Cherry anthocyanins have been shown to reduce pain and inflammation."
•"Cherries have also been shown to contain high levels of melatonin. Research has shown that people who have heart attacks have low melatonin levels."
•"There is considerable interest at present in the use of fresh cherries or cherry juice to treat gout -a painful inflammatory joint condition. In 2007 a study at the University of Pittsburgh
discovered that anthocyanins kills [sic] human cancer cells while not affecting healthy cells. "
'"Made from Montmorency tart cherries, this super cherry concentrate offers a variety of possible health benefits including fighting cancer, heart disease, arthritis, gout, and headaches."
•"Michigan State University has been researching the benefits of cherries and they have found
that they are known to reduce the pain of arthritis, gout and headaches."
• "Anthocyanins are anti-inflammatory pain relievers 10 times stronger than aspirin or ibuprofen.""There is also evidence that cherries are so powerful they may reduce the risk of cancer by fifty percent. . . .`It appears that cherries shut down the growth of cancer [sic] cells by depriving them of the proteins they need to grow,' explains Dr. Hohl."
Your web site also includes claims in the form of testimonials. Some examples are as follows:
• "My arthritis is not severe but I have had serious gout-like symptoms: open leg sores, itchy wrists, itchy acid blisters, and a back pain so severe I could not stand straight. I have learned to control this . . . especially by taking tart cherry juice."
• "When I was 45 I hurt my shoulder and after [sic] I had a bone density test I was diagnosed with [sic] osteoporosis [sic]. I could not have a new shoulder because it would never heal. So painkillers were my only option until I heard about Cherry Juice Concentrate from Sleeping Bear Farms. Within days of me drinking the Cherry Concentrate I hade[sic] less pain in my shoulder and body. I experimented with the concentrate in different drinks and found that . . . the pain had decreased. I told my family and before you knew it they are all drinking it and feeling better. So I no longer take pain killers but drink a glass of Cherry Concentrate(or two) daily."
Real Raw Honey
• "As an antimicrobial agent raw honey has potential for treating a variety of ailments, including
• "According to reputable sources like . . . the University of Illinois at Urbana-Champaign, certain anti-oxidants and vitamins found in real raw honey are known to lower cholesterol and fight its accumulation in the body ." [reference numbers omitted]
This list of claims is not intended to be all-inclusive, but represents the types of claims found in your product labeling.
These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] . Because these 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 [21 U.S.C. 321(p)]. 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. Your products Michigan Montmorency 100% Pure Cherry Juice Super Concentrate and Real Raw Honey are also misbranded within the meaning of Section 502(f)(1) of the Act in that the labeling of these drugs fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].
In addition to being unapproved new drugs, your Sleeping Bear Farms Real Raw Honey and Michigan
Montmorency 100% Pure Cherry Juice products are also misbranded foods.
The products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the Real Raw Honey label bears the nutrient content claim "contains antioxidants" and the Michigan Montmorency 100% Pure. Cherry Juice Super Concentrate bears the nutrient content claims "rich in antioxidants" and "rich source of 17 naturally occurring antioxidants," but both labels fail to list the names of the antioxidants that are the subject of these claims, as required by 21 CFR 101.54(g)(4).
Additionally, your Michigan Montmorency 100% Pure Cherry Juice Super Concentrate product is misbranded within the meaning of section 403(q)(2)(A) of the Act [21 U.S.C. 343(q)(2)(A)] because the label fails to declare trans fat, as required by 21 CFR 101.9(c)(2)(ii).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
Failure to promptly correct these violations may result in enforcement action without further notice. Enforcement action may include seizure of violative products, injunction against the manufacturers and distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. You should include in your response documentation of your corrective actions, 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 directed to Judith A. Putz, Compliance Officer, at the above address.
In addition to the above violations, we also have the following comments about the labeling of these
• The net quantity of contents statement on the Real Raw Honey product is not located on the
principal display panel as a distinct item in the bottom 30 percent of the panel, as required by 21 CFR 101.105(f).
• The percent juice statement "100% Pure Cherry Juice" on your Michigan Montmorency 100% Pure Cherry Juice Super Concentrate product should not be declared within the Nutrition Facts panel. This declaration must be placed on the information panel, as required by 21 CFR 101.30(e), and may also appear on the principal display panel under 21 CFR 101.30(f).
• The serving size on the "Nutrition Facts" panel on your Michigan Montmorency 100% Pure Cherry Juice Super Concentrate product is not expressed in a common household measure approp ri ate to the food, as required by 21 CFR 101.9(b)(1). Because this product is a concentrate, rather than a beverage, the serving size must be expressed in cups, tablespoons, or teaspoons [21 CFR 101.9(b)(5)(i)].
• The nutrition information declared on the label of your Michigan Montmorency 100% Pure Cherry Juice Super Concentrate product does not meet the formatting requirements of 21 CFR 101.9 (c) and (d) regarding use of bold type and indentation.
Joann M. Givens
Detroit District Office