Big Pharma's Lunatic FDA
Says Cherries Are Now DRUGS

From Mary Sparrowdancer
sparrowdancer1@earthlink.net
3-11-7

http://www.rense.com/general75/cberries.htm

Jeff - Here's something interesting: according to the FDA, cherries are now drugs.
 
 
I've been looking into tart cherry juice concentrates today. I've found that there is one type that contains all sorts of natural antioxidants, plus a bunch of other good stuff, including melatonin and more. This type of cherry is called the Montmorency cherry.
 
 
People are taking the concentrate or eating the cherries for pain which about 2/3 of the US now has due to fluoride poisoning...and those savvy to the cherry benefits are discontinuing prescription drugs as a result. They're claiming it's also healing all sorts of things, including cancers, gout, arthritis.
 
 
Looking closer, nearly all of the many companies I looked into this afternoon have received WARNING letters from the FDA stating that because of their claims about the healing properties of tart cherries, the cherry juice and/or cherries are therefore considered to be a "drug," and the vendors must file a "New Drug Application."  What crap is this!!!!!!!!
 
 
Big pharma must be very, very scared about tart cherry juice. I am, therefore, going to order some right away. 
 
Here are two examples of FDA letters - note that they specifically cited the suggestion that the consumer can stop taking prescriptions if they will begin taking tart cherries in some form. 
 
Anyway, it appears that as long as food is empty of all nutrients, then it is "food" - but if it has any health-promoting nutrients or benefits at all, then it is considered a new drug in the US, hence a "New Drug Application" must be made.
 
 
http://www.casewatch.org/fdawarning/prod/2005/seaquist.shtml
http://www.casewatch.org/fdawarning/prod/2005/overlake.shtml
 
 
Here's the list of all of them, dated 2005. The firms are all still advertising the same health benefits on their sites, so I guess they've given the FDA a Bronx raspberry re the Montmorency cherry scandal.  
http://www.cfsan.fda.gov/~dms/chrylist.html

Department of Health and Human Services

Public Health Service
Food and Drug Administration
Central Region
Minneapolis District
  212 3rd Ave S
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

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:

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.

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

Public Health Service
Food and Drug Administration
Pacific Region
Seattle District
  22201 23rd Dr SE
Bothell, WA 98021-4421
Telephone: 425-488-8788
FAX: 425-483-4998

October 17, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Rodney L. Cook, President
Overlake Foods Corp.
PO Box 2631
Olympia, WA 98507-2631

Ref. No. SEA-06-05

Dear Mr Cook:

The Food and Drug Administration (FDA) has reviewed the labeling for your Blueberry Concentrate and Tart Cherry Concentrate on your website at www.overlakefoods.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 USC 321(g)(1)(B)]. The labeling for your products bear the following claims:

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 a 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, 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. Your reply should be sent to the Food and Drug Administration, Attn: Lisa Althar, Compliance Officer, 22201 23rd Dr SE, Bothell, WA 98021-4421.

Sincerely,
/s/
Charles M. Breen
District Director

This page was posted on March 28, 2006.

List of Firms Receiving Warning Letters Regarding Cherry and other Fruit-Based Products with Disease Claims in Labeling

Sample Warning Letter

Firm Product(s)
Amon Orchards (available in PDF)
Acme, MI
Tart Cherry Juice Concentrate
Brownwood Acres (available in PDF)
Eastport, MI
Juice Concentrates (Cherry, Blueberry, and Pomegranate)
Cherry Flex Soft Gel Capsules
Cherry Lands Best (available in PDF)
Appleton, Wisconsin
Tart Cherry Juice Concentrate
Cherry Republic (available in PDF)
Glen Arbor, MI
cherry products
Cherry Rx (available in PDF)
Genoa City, Wisconsin
Cherry RX
Chukar Cherry Company (available in PDF)
Prosser, Washington
cherry and chocolate covered cherry products
Coloma Frozen Foods (available in PDF)
Coloma, MI
Nature Blessed Montmorency Tart Cherry Juice Concentrate
Country Ovens, Ltd. (available in PDF)
Forestville, Wisconsin
Natural Cherry Juice Drink
Cherry De-Lite
Eden Foods, Inc. (available in PDF)
Clinton, MI
Cherry and Apple Juice Concentrates
Cherry and Apple Juice
Apple Juice, Cherry/Apple juice blend
dried cherries
Flavonoid Sciences (available in PDF)
Traverse City, MI
CherryFlex
Wild Blueberry IQ
Friske Orchards (available in PDF)
Ellsworth, MI
cherry products
Heritage Products International (available in PDF)
Livonia, MI
Cherry Juice Concentrate
tart cherry capsules
H & W Farms (available in PDF)
Belding, MI
Tart Cherry Juice Concentrate
King Orchards (available in PDF)
Central Lake, MI
Cherry Juice Concentrate
dried tart cherries
Leelanau Fruit Company (available in PDF)
Suttons Bay, MI
Cherry Juice Concentrate
dried tart cherries
Cherry Flex
Blueberry IQ
other cherry and blueberry products
Leland Cherry Company (available in PDF)
Leland, MI
Michelle's Miracle Tart Cherry Juice Concentrate
Obstbaum Orchards (available in PDF)
Salem, MI
Cherry Juice Concentrate
Orchard's Harvest (available in PDF)
d.b.a. The Cherry Stop
Traverse City, MI
Cherry Juice Concentrate
Cherry Flex gelcaps
other cherry products
Overlake Foods Corporation (available in PDF)
Olympia, Washington
Blueberry Concentrate
Tart Cherry Concentrate
Payson Fruit Growers, Inc. (available in PDF)
Payson, Utah
cherry juice concentrate
dried tart pitted cherries
other cherry products
Rowley and Hawkins Fruit Farms (available in PDF)
Basin City, Washington
Tart Cherry Juice
other cherry containing products
Rowley's South Ridge Farms, Inc. (available in PDF)
Santaquin, Utah
Red Tart Cherry Concentrate
other cherry products
Royal Ridge Fruit & Cold Storage (available in PDF)
Royal City, Washington
Royal Ridge Montmorency Dried Cherries
Pure Cherry Juice Concentrate
Seaquist Orchards (available in PDF)
Sister Bay, Wisconsin
cherry products
Skyview Orchards (available in PDF)
Ludington, MI
Cherry Juice Concentrate
Cherry Capsules
Sunrise Dried Fruit Co. (available in PDF)
Northport, MI
Cherry Juice Concentrate
dried cherries
The Country Mill, LLC (available in PDF)
Charlotte, MI
DocCherry Cherry Juice
TPG Enterprises, Inc. (available in PDF)
Othello, Washington
Tart Cherry Cancentrate
Fresh Apple Slices
Traverse Bay Farms (available in PDF)
Bellaire, MI
Cherry Juice Concentrate
Wild Blueberry Juice Concentrate
Fruit Advantage Tart Cherry Capsules