Link: FDA and nutritional claims for cherries

[Guest guest]

The FDA is turning up the heat on those who make nutritional claims for

cherries. A part of the article is copied below:

 

The highly respected Casewatch.org, which monitors " health fraud and

quackery-related legal matters, " cautions in its listings of companies

that have received warning letters [including the cherry farmers and

distributors] that " it is wise for consumers to assume that the product is

problematic and should be avoided. " In addition, such a letter officially

opens the door to a raid by federal agents in which they may seize

products, computers, and other such items and shut businesses

downand possibly even file criminal charges against the owners.

 

All of that helps explain why Michael Berst, sales manager of King

Orchards, a 300-acre cherry farm not far from Traverse City, Mich., that

was one of the recipients of the FDA letter, " lived all winter in terror they

would come after us. " Just because the FDA hasn't come doesn't mean

it won't. The warning letter is open-ended, meaning the marshals could

show up tomorrow, or could show up 10 years from now.

 

Read the whole article at:

http://news./s/bw/20060627/bs_bw/sb20060626541703

[Guest guest]

I found the enforcement letter from the FDA online at:

http://www.fda.gov/foi/warning_letters/g5534d.htm

 

Check out this paragraph:

" 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. "

 

So anything that will claim to cure has to be drug, and needs to be

approved by the FDA! Talk about absolute power!

 

Ron

 

RawSeattle , " Ron Koenig " <theveganking

wrote:

>

> The FDA is turning up the heat on those who make nutritional claims for

> cherries.

[Guest guest]

Yes Ron, that is the law. The only reason that herbs and most " natural "

products are marketed without much FDA oversight is the part of the Act

which states that they can't make drug-like claims about function or cure.

If they make drug-like claims, then they are to be treated as a new drug.

Makes a lot of sense to me. Better than having them be treaded like drugs

period, which is how they would have been covered under the law as

originally written. Now, that doesn't stop you or anyone else from making

unproven claims or saying what you like as long as you aren't " selling " the

product. Some foods can now make certain health claims, but only if

scientific studies are conducted and pass FDA muster

 

I find this much preferable to big business (and yes, " natural " products are

very big business) making whatever claims they wish about their products.

That takes us back to the old " snake oil " days! The FDA has pulled some

boners these days and is not very well favored among some mindsets, but

they've historically done a good job at protecting the public from

unscrupulous business practices, within their limits of law, and for

labeling requirements. See

http://www.fda.gov/opacom/backgrounders/miles.html for some milestones

 

Hiss Hiss

 

Richard

 

-

" Ron Koenig " <theveganking

<RawSeattle >

Thursday, July 13, 2006 4:55 PM

[RawSeattle] Re: Link: FDA and nutritional claims for cherries

 

 

>I found the enforcement letter from the FDA online at:

> http://www.fda.gov/foi/warning_letters/g5534d.htm

>

> Check out this paragraph:

> " 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. "

>

> So anything that will claim to cure has to be drug, and needs to be

> approved by the FDA! Talk about absolute power!

>

> Ron

>

> RawSeattle , " Ron Koenig " <theveganking

> wrote:

>>

>> The FDA is turning up the heat on those who make nutritional claims for

>> cherries.

Visit the Seattle Raw Foods Community: http://rawseattle.org

>