Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8200
313-393-8139

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

October 22, 2008

Kirk D. Jones, President
Sleeping Bear Apiaries
971 S. Pioneer Rd.
Beulah, MI 49617-9778

WARNING LETTER
2009-DT-04

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.

New Drugs

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

On label:

On wwww.sleepingbearfarms.com

Your web site also includes claims in the form of testimonials. Some examples are as follows:

Real Raw Honey

On www.sleepingbearfarms.com:

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)].

Misbranded Foods

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 products:

Sincerely yours,

/S/

Joann M. Givens
District Director
Detroit District Office

This page was posted on July 19, 2010.

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