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Public Health Service |
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212 3rd Ave S |
Department of Health and Human Services October 17, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Jim Seaquist, President
Seaquist Orchards
11482 Hwy 42
PO Box 204
Sister Bay, WI 54234
Ref. No. MIN-06-04
Dear Mr Seaquist:
The Food and Drug Administration (FDA) has reviewed the labeling of your cherry products on your website at www.seaquistorchards.com. This 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 United States Code (21 USC 321(g)(1)(B)]. The labeling for your cherry containing products bears the following claims:
- “[N.W.] … recently stopped taking drugs for arthritis pain not long after he began eating 50 tart cherries a day. … It was very dramatic. Within two days the pain was gone.…”
- “[T]here are beneficial compounds in Montmorency tart cherries that help relieve the pan [sic] of arthritis and gout. … [M]any consumers are discovering that tart cherry juice and other cherry products can stave off pain.”
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 USC 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 USC 321(p)].
Under Section 505 of the Act (21 USC 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.
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, of 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.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.
Sincerely,
/s/
W. Charles Becoat
District Director
This page was posted on March 28, 2006.
