Fwd: WSJ reports on FDA warning letters

December 21, 2001

The Campaign <information wrote: The Campaign

angelprincessjo

WSJ reports on FDA warning letters

Fri, 21 Dec 2001 05:25:02 PST

News Update From The Campaign to Label Genetically Engineered Foods

----

Dear Health Freedom Fighters,

The Wall Street Journal featured an article in Thursday's paper titled

" FDA Warns of Misleading Labels On Genetic Modification in Foods. "

The article reports that the U.S. Food and Drug Administration (FDA)

sent letters to six natural food companies expressing concern that they

may be misleading consumers with labels indicating their products are

free of genetic modification.

Although not mentioned in the Wall Street Journal article, the letters

from the FDA to these natural food manufacturers may have been sent as a

result of the Center for Science in the Public Interest (CSPI)

requesting the FDA take this action.

On August 14, 2001, CSPI asked the FDA to take action against seven

companies " whose product labels deceive consumers with false or

misleading claims about the absence of genetically engineered (GE)

ingredients. "

The FDA letter went out to six of the seven companies targeted by CSPI.

Much to the disappointment of many people in the nutrition and

environmental communities, CSPI has been supporting genetically

engineered foods. CSPI received a grant of $200,000 in October 2000 from

the pro-biotech Rockefeller Foundation to go towards " the costs of a

project to broaden public debate on genetic engineering in agriculture

and to encourage improved regulations in biotechnology. "

The letters from the FDA are most likely meant to intimidate natural

foods companies. It would be premature for the FDA to actually demand

the companies remove these products from being sold because the agency

has not yet issued either " Proposed Rules " or " Final Rules " regarding

the labeling of non-genetically engineered foods.

So far, all the FDA has issued is a document titled " Draft Guidance for

Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not

Been Developed Using Bioengineering. " Again, the FDA has not yet issued

any formal " Rules " on labeling non-genetically engineered foods.

If the FDA actually demanded that these products be recalled as

mislabeled, the companies could fight the FDA in court and would

probably win. The courts would likely determine that such FDA action is

" arbitrary and capricious " without rules being in place. But most

companies do not want to get involved in a costly court battle with the

FDA.

THE CAMPAIGN'S POSITION ON " NON-GMO " AND " GMO-FREE " LABELING

In the FDA's " Draft Guidance for Industry: Voluntary Labeling Indicating

Whether Foods Have or Have Not Been Developed Using Bioengineering, " the

agency questioned the use of the term " GMO-Free " arguing that it could

be misleading to consumers.

The FDA's position is that GMO-Free indicates a product is 100% free of

GMOs and that this is not possible. (Sadly, one of the primary reasons

100% GMO-Free is not possible is because of contamination from

cross-pollination.) The FDA also questioned the term " Non-GMO " and

suggested a term such as " not developed using bioengineering " would be a

more appropriate label.

The position of The Campaign to Label Genetically Engineered Foods is

that the term " Non-GMO " should be permitted, but not the term

" GMO-Free. " We base our position on the way the government uses the

terms " Free " and " Non " in the regulation of alcoholic beverages. An

" Alcohol-Free " beer must be 100% free of alcohol. A " Non-Alcoholic " beer

can have up to 0.5% alcohol.

Since there is a government precedent for the use of the terms " Free "

and " Non, " The Campaign feels this same criteria should be applied to

indicating the presence of genetically engineered ingredients. A product

grown and processed without genetically engineered ingredients should

qualify for a " Non-GMO " or similarly worded label even if the product

has very low levels of GMOs unavoidably present. (A threshold needs to

be established somewhere below 1%, perhaps as low as 0.1%.)

While The Campaign to Label Genetically Engineered Foods agrees that a

" GMO-Free " label may be misleading, we feel that the organic and natural

foods industries should fight for the right to have a " Non-GMO " label on

their products.

Before implementing labeling restrictions, the FDA will first need to

issue " Proposed Rules " and allow for a comment period. After reviewing

the comments for several months, the FDA will eventually issue " Final

Rules. " Even then, there is usually a significant time frame allowed for

implementation of the " Final Rules " to allow manufacturers time to

modify their labeling to comply with the rules and use up existing

inventories.

The Campaign to Label Genetically Engineered Foods encourages companies

using a " Non-GMO " or " Non-Genetically Engineered " label to keep that

labeling in place and not feel intimidated by the FDA. Although the FDA

can be unpredictable at times, it is unlikely they are going to demand

any products be removed from the shelves with a " Non-GMO " or

" Non-Genetically Engineered " label before issuing " Proposed Rules " and

" Final Rules " regarding this issue.

When the FDA finally gets around to issuing " Proposed Rules " on labeling

products produced without genetically engineered ingredients, we hope

the natural foods industry will fight for the right to have a " Non-GMO "

or " Non-Genetically Engineered " label.

The biotech industry does not want the terms " non-genetically

engineered " or " Non-GMO " used. They prefer the terminology " not

developed using bioengineering. " Why? Because their market surveys show

people react negatively to the terms " genetically engineered " and

" GMOs. " People find the term " biotechnology " less frightening.

Since the biotech industry seems to get the FDA to do whatever they

want, we expect that the FDA will issue " Proposed Rules " favoring the

desires of the biotech industry. Consumers and the natural food industry

should be prepared to fight the FDA over this issue and not let the

biotech industry have it's way.

Posted below is the Wall Street Journal article titled " FDA Warns of

Misleading Labels On Genetic Modification in Foods. " We also posted a

copy of a CSPI Press Release from August 14, 2001, that discusses their

request for the FDA to take this action.

Craig Winters

Executive Director

The Campaign to Label Genetically Engineered Foods

The Campaign

PO Box 55699

Seattle, WA 98155

Tel: 425-771-4049

Fax: 603-825-5841

E-mail: label

Web Site: http://www.thecampaign.org

Mission Statement: " To create a national grassroots consumer campaign

for the purpose of lobbying Congress and the President to pass

legislation that will require the labeling of genetically engineered

foods in the United States. "

***************************************************************

Wall Street Journal

Thursday, December 20, 2001

FDA Warns of Misleading Labels On Genetic Modification in Foods

by Scott Kilman

The Food and Drug Administration, trying to douse one of the hottest

trends in food retailing, is warning Hain Celestial Group Inc. and five

other natural-foods companies that they are misleading consumers with

labels touting products as free of genetic modification.

The non-GMO label -- the initials stand for " genetically modified

organisms " -- is on hundreds of food products. Virtually unknown in

North America just three years ago, the label is materializing on

everything from pasta and breakfast cereal to baby food and jam.

The label is popular because repeated surveys show that the majority of

U.S. consumers want to know about the presence of genetically modified

ingredients, apparently so that they can choose whether to avoid them.

But the FDA letters, issued on Nov. 29, reflect the growing concern of

agency officials that some marketers might be trying to play to the

public's worries about an unfamiliar technology -- which that FDA has

declared is safe.

" We want to stop misleading statements, " said Christine Taylor, director

of the FDA office that supervises label claims.

It's far from clear, however, exactly what a food company can legally

say about its efforts to avoid biotechnology. The agency is still wading

through 55,000 comments on the wording guidance it wants to issue to

companies.

Among other things, the FDA wants to stop companies from claiming

products are free of genetically modified ingredients. Regulators fear

consumers equate such a claim with a healthier product, much as dieters

seek out fat-free products.

The FDA also doubts that food companies can make a non-GMO claim with

absolute certainty. The Wall Street Journal, for a page-one article on

April 5, had a food laboratory analyze products that bore labels

claiming that none of the ingredients were genetically modified. Of the

20 products tested, 16 contained evidence of genetic material used to

modify plants.

The FDA complained in its letter that some Hain products -- such as

Bearitos tortilla chips -- are labeled as " pure " with the claim that

they don't contain genetically engineered ingredients. Hain, Uniondale,

N.Y., didn't return phone calls seeking comment on the FDA letter, which

asks the company to explain how it intends to comply with branding laws

that prohibit misleading labels.

Some companies quickly backpedaled after receiving the FDA letter.

Healthy Times Inc., a closely held maker of natural baby food, will

probably drop its non-GMO label. " We have a natural philosophy, so we

avoid GMOs, " said Richard Prescott, who runs the small Poway, Calif.,

company with his wife. " But we aren't big enough to the fight the FDA, "

he said.

U.S. Mills Inc., Needham, Mass., said it will try to reword the label on

its Erewhon brand of breakfast cereal and move it to a less conspicuous

spot on the box. " We need the information [on the box] or people will

constantly call us, " said Charles T. Verde, president of the company.

" The FDA is way out of line on this. "

The FDA letters also were sent to Spectrum Organic Products Inc. in

Petaluma, Calif.; B & G Foods Inc., Parsippany, N.J.; and Van's

International Foods, Torrance, Calif.

***************************************************************

CSPI Press Release

August 14, 2001

CSPI Urges FDA to Halt Misleading ‘Non-genetically Engineered’

Food-label Claims

(Washington) The Center for Science in the Public Interest (CSPI) today

asked the U.S. Food and Drug Administration (FDA) to take enforcement

action against seven food manufacturers whose product labels deceive

consumers with false or misleading claims about the absence of

genetically engineered (GE) ingredients.

CSPI’s complaint concerns Polaner’s All Fruit Spreads, Earth’s Best Baby

Foods, Healthy Times Oatmeal with Banana Cereal, Van’s Organic Waffles,

Spectrum Canola Oil, Bearitos Tortilla Chips, and Erewhon Wheat Flakes.

CSPI is not concerned about the quality or safety of the products, but

charges that their labels violate the Federal Food, Drug, and Cosmetic

Act and FDA’s guidance about labeling foods for GE content. Some

examples include:

Earth’s Best Apples and Apricots baby food implies that it is superior

to competing, similar products by stating at least seven different times

on the package that it contains “NO GMO’s” (genetically modified

organisms). Although technically accurate, that claim is misleading

because no baby food contains “organisms,” and no brand of apples and

apricot baby foods, not just Earth’s Best, contains GE ingredients.

Erewhon Wheat Flakes implies that it is superior to competing products

by stating that it is “100% Natural”and does not contain “Genetically

Engineered Ingredients.” In fact, no GE wheat is present in any food.

Polaner’s All Fruit Strawberry states that it is “NOW GMO FREE,” yet

this jam-like product made primarily with strawberries and fruit juices

does not, and never did, contain “organisms.“

“Consumers want information about GE ingredients in their foods, but

that information should be presented in an accurate and non-disparaging

manner,” said Gregory Jaffe, co-director of CSPI’s Biotechnology

Project. “These labels bear false or misleading statements such as ‘No

GMO’s’ that take unfair advantage of consumer concerns and lack of

knowledge about GE crops. The labels imply that the absence of GE

ingredients makes the products superior, when that is not the case.”

FDA, the American Medical Association, and many other health

organizations have determined that GE crops are as safe to eat as

traditionally bred crops. In fact, traditionally bred crops may be

treated with more pesticides, or more dangerous pesticides than their

bioengineered counterparts.

“Although CSPI favors labeling of GE ingredients, these seven products

show that manufacturers are taking advantage of consumers with false and

misleading label statements,” added Jaffe.

CSPI recently conducted a national opinion poll that found that labels

stating “GE”or “non-GE” would influence many consumers’ perceptions and

preferences. About 31% of consumers said that products labeled GE were

not as safe as non-GE foods. A similar percentage said that foods

labeled “does not contain genetically engineered ingredients” were

better than unlabeled foods. Only about 10% said that the GE-labeled

product was safer or better. (33% to 42% said that GE and non-GE foods

were just as safe or good).

Given many consumers’ innate skepticism of any new technology, CSPI said

that manufacturers must be careful not to mislead consumers. “FDA needs

to send a clear message to manufacturers that label statements need to

be both accurate and not imply superiority,” added Jaffe. Anticipating

the day when biotechnology is used to provide consumer benefits, CSPI’s

letter also urged the FDA to guard against deceptive claims about such

benefits. “The FDA should nip this growing problem in the bud.”

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December 26, 2001

Please note that Spectrum Canola is among those listed as suspect by the FDA.

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