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

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.

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:

• Under "Health Benefits of Red Tart Cherries":
  • "Anthocyanins in tart cherries … may relieve pain better than aspirin. Studies done … found that anthocyanins from raspberries and cherries…, including Montmorency cherries, demonstrated a Cox 1 and 2 inhibitory affect [sic] equal to that of 10 microM concentrations of ibuprofen and naproxen … Anthocyanins inhibit the ability of Cox-2 to cause pain.""Pain relief from eating tart cherries could give relief from arthritis, … and gout, without side effects like stomach and kidney problems that result from aspirin and ibuprofen."
  • "Melatonin is found in extremely high doses … in tart cherries. … The presence of melatonin … in cherries could have a wide range of health benefits including … preventing cancer by acting as a powerful antioxidant.…"
  • "Cherries naturally contain perillyl alcohol, a dietary monoterpene. This phytochemical is naturally found in lavender, cherries and mint, and has been shown in several studies to bind with protein molecules to inhibit the growth signals that stimulate tumor development."
  • "In laboratory studies perillyl alcohol has been shown to initiate regression of pancreatic, breast and liver tumors. It has the potential to act as a chemopreventative agent for colon, skin and lung cancer and chemotherapeutic agent for neuroblastoma (a childhood ganglia related cancer), prostate and colon cancers."
• Under "Health Benefits of Blueberries":
  • "Blueberries contain folic acid, which … may help protect against cervical cancer."
  • "Ellagic acid, a potent anti-carcinogen, is found in blueberries. Ellagic acid has been shown in laboratory test to shrink colon and esophageal tumors."

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