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March 25 - The Center for Science in the Public Interest
(CSPI) today urged the Food and
Drug Administration (FDA) to tighten controls over the marketing of so-called
functional foods made with herbal medicines, amino acids, plant extracts, and
other unconventional ingredients. CSPI urged the agency to ensure that all such
ingredients are safe and that label claims are valid.
“Functional foods” typically tout the health
benefits of ingredients that have drug-like effects on the body. While current
FDA regulations generally prohibit the use of untested ingredients and
unapproved health claims, companies get around those rules by taking advantage
of a variety of regulatory loopholes.
In a letter to FDA Commissioner Jane Henney,
CSPI charged that “functional foods hold much promise, but, without effective
regulation, may merely become the snake oil of the next century.” The letter was
accompanied by a report entitled “Functional Foods — Public Health Boon or
21st Century Quackery.”
The report details how companies are using
regulatory loopholes — such as selling foods as dietary supplements or medical
products — to market “functional foods” in the U.S., the United Kingdom, and
Japan. A report on “functional foods” is also the cover story of CSPI’s April
issue of Nutrition Action Healthletter (NAH), which
reaches over one million subscribers.
“The FDA is failing to protect the public from
numerous questionable ingredients and misleading claims in the estimated
$15-billion-a-year ’functional-foods’ market,” stated Bruce Silverglade, CSPI
director of legal affairs. “All too often, companies are merely trying to cash
in on the burgeoning demand for alternative health remedies,” he said. Product
examples include:
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Hain’s Chicken Broth and Noodles with Echinacea. The label claims
that Echinacea helps “support the immune system.” The soup is labeled as a
“supplement” in an attempt to evade FDA requirements for food additives and
label claims.
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Brain Gum, a chewing gum with phosphatidyl serine (PS). PS is a
fat-like substance extracted from soybeans that is also found naturally in brain
cells. The product claims to “improve concentration” and is sold as a dietary
supplement presumably to avoid FDA rules governing foods.
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HeartBar, a snack bar with
L-arginine. Arginine is an amino acid
required to produce nitric oxide, a potent dilator of blood vessels. The product
claims that it is “for the dietary management of vascular disease.” It is
labeled as a medical food for “use under the supervision of a physician” in an
attempt to evade FDA rules that require pre-market approval of health claims for
conventional food products.
Some “functional foods” may contain
insignificant amounts of the promoted ingredient, while others contain too much
fat or sugar. For example:
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Snapple Ginseng Tea labels do not list ginseng content and the
company refuses to disclose the information.
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Kellogg’s Ensemble Carrot Cake labels state that the product
contains psyllium, “a natural soluble fiber that actively works to promote heart
health.” Psyllium can help reduce cholesterol. The cake, however, contains too
much fat to qualify for an FDA-approved heart-disease-prevention claim so the
company merely claims it can “promote heart health.”
In other situations, conventional foods are
misleadingly marketed as “functional foods” on the basis of the purported effect
of a naturally occurring ingredient. For example:
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Heinz advertises that lycopene in catsup “may help reduce the risk
of prostate and cervical cancer.” The company only makes the claim in ads and
not on labels because the Federal Trade Commission (FTC), which regulates
advertising, does not require pre-market approval of such claims and employs
weaker substantiation standards than the FDA.
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Campbell’s V8 Juice labels and ads state that antioxidants in the
product “may play an important role in slowing changes that occur with normal
aging.” The claim is based on preliminary scientific evidence. In any case, the
juice is high in sodium, which promotes high blood pressure, a condition that
becomes more prevalent with aging. The sodium content disqualifies the juice
from making any FDA-approved health claim on labels. Neither the FTC nor the FDA
have taken any public action to stop the claim.
The FDA recently stopped McNeil Consumer
Products from marketing Benacol margarine as a dietary supplement rather than as
a food. The product contains plant stanol esters that reduce blood cholesterol.
The FDA’s action prohibited the company from selling the product until it could
demonstrate that the “functional” ingredient in the margarine was safe for use
in foods (the agency has not yet determined what claims, if any, could be made
on the label). Although the FDA acted in that case, CSPI’s report reveals that
the agency has generally failed to require proof of safety for ingredients in
other functional foods and has failed to stop many dubious label
claims.
“The FDA must beef up its enforcement actions,
close the loopholes, and require that all functional ingredients are safe and
that claims are valid,” stated Ilene Ringel Heller, a senior CSPI staff attorney
who co-authored the report.
In contrast, the food industry is calling on the
FDA to “revamp its application review process” for ingredients and claims and
“eliminate unnecessary regulatory roadblocks.” In its report, however, CSPI
detailed how companies take advantage of the already lax regulatory environment
to flood the market with products of dubious benefit.
In its letter and report, CSPI urged the FDA
to:
- Require that functional ingredients be proven
safe prior to marketing.
- Require claims to be approved by the agency or
be based on scientific consensus.
- Issue rules that require labels to disclose how
much of a “functional” ingredient a serving of the food contains, how much
people should consume, and, if appropriate, warning information.
- Prevent companies from selling “functional
foods” as dietary supplements or “medical foods” in order to escape FDA
regulation.
- Work with the FTC to develop a consistent
policy for claims in advertising and labeling.
EDITORS/REPORTERS NOTE:
For a copy of the CSPI report
on “functional foods” please call Dori Feinman at 202-332-9110 ext. 358 or
Amisha Upadhyaya at ext. 362.
The Center for Science in the Public
Interest is a nonprofit health-advocacy group based in Washington, D.C. It is
well-known for leading the drive for mandatory nutrition labeling of practically
all foods and advocating improved food-safety inspection programs. CSPI is
supported largely by the one million U.S. and Canadian subscribers to its
Nutrition Action Healthletter.
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