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Functional Foods Under Attack

The Center for Science in the Public Interest is calling on the U.S. Food and Drug Administration to stop the sale of functional foods, which with an extra ingredient that is supposed to have a health benefit. The group says the safety of many of these ingredients is simply not known.

The Center for Science in the Public Interest (CSPI) today urged the U.S. Food and Drug Administration (FDA) to stop the sale of more than 75 "functional foods" that contain ingredients not considered by the agency to be safe.

Functional foods are foods with an extra ingredient that is supposed to provide a health benefit beyond basic nutrition. They include things like ginseng tea and St. John's Wort chips. CSPI is urging the FDA to order manufacturers to stop making false and misleading claims about their products. CSPI says that herbs are medicines and they don't belong in foods.

The FDA allows companies to add ingredients proven safe to food, such as calcium in orange juice. But the agency says herbal supplements have not been proven safe for use in food. In fact, the FDA has warned three companies that their foods containing herbs are in violation of the law.

One of the major problems is that consumers don't know how much of an herbal supplement they are getting in each product because it's not on the label. Also, food makers don't know if a person is going to eat one serving or six servings of their herbal food. If you get too much of it, it could be damaging to your health. If you don't get what you think you are getting, you're wasting your money.

Food groups and manufacturers say that functional foods are regulated just like conventional foods and there is ample regulation to make sure that products on the market are safe and that all the ingredients are not adulterated and that all labeling is truthful and not misleading.

Americans spent more than $16 billion dollars on functional foods last year and that number is expected to triple in the next ten years.

The US's General Accounting Office (GAO) issued a report last week that strongly criticized the FDA's regulation of functional foods. The GAO stated, "FDA's efforts and federal laws provide limited assurances of the safety of functional foods" The report concluded while the extent to which unsafe functional foods reach consumers is unknown, the FDA should protect the public by halting misleading claims and requiring warning labels where appropriate. The report also concluded that Congress should require companies to notify the FDA before using new "functional" ingredients.

Manufacturers promote "functional foods" for their added health benefits. But, serious adverse effects have been linked to the ingestion of several "functional" ingredients.

For example, the FDA recently issued a Public Health Advisory on the risk of drug interactions with St. John's Wort, a popular herb for the treatment of depression. Researchers discovered a significant interaction between the suppement and protease inhibitors used to treat HIV infection. Potential interactions may occur also with respect to drugs used for heart disease, depression, seizures, transplant rejection and contraception.

Kava Kava, an herb can cause over sedation and increase the effects of substances that depress the nervous system. It has also been associated with tremors, muscle spasms and abnormal movements that may interfere with the effectiveness of drugs prescribed for the treatment of Parkinson's disease.

Ginkgo, an herb can act as blood thinner. Taking it with other anticoagulants may increase the risk of excessive bleeding or stroke.

Echinacea--A study released by the American Academy of Allergy, Asthma and Immunology indicates that Echinacea can cause allergic reactions, including asthma attacks. There is also concern that immune stimulants like Echinacea could counteract the effects of drugs that are designed to suppress the immune system.

Bruce Silverglade from the Center fr Science in the Public Interest says that these products are 21st Century quackery. Food companies are spiking fruit drinks, breakfast cereals and snack foods with illegal ingredients and then misleading consumers about their health benefits. It's shameful that respected companies are selling modern-day snake oil.

Functional foods are defined as foods with an added ingredient to provide some sort of extra health benefit. In most cases these foods are infused with herbs. The herbs vary from the useless--blue-green algae which has been shown to be ineffective, to very potent--Kava Kava which is a sedative.

The FDA has said that the addition of these substances to foods is illegal. Ingredients in food must be proven to be safe before being added to food. In most cases these additives are not proven safe. The FDA isn't enforcing its own regulations. Today, the CSPI filed 158 pages of complaints with the FDA asking them to enforce their regulations. In addition, CSPI wants the FDA to issue new regulations that would prohibit manufacturers from making misleading claims.

Usually the amount of these herbs in these products is so small that it does no good whatsoever. It is just added as a marketing gimmick. But if there is a substantial amount of the herb in the product, sometimes consumers eat four servings instead of one and get too much of the herb.

Dr. Stacey Zawel from Grocery Manufacturers of America, the world's largest association of food, beverage and consumer product companies, says that the CSPI proposal to ban a broad array of so called functional foods is a frenzied overreaction. Functional foods are just foods. They already meet stringent federal food safety regulations. The food police are once again muddying the regulatory waters and are seeking to confuse consumers ever the rules governing functional foods.

CSPI may not like it, but food companies have a constitutional right to make health-related information available to consumers. s long as the claims are true, manufacturers can put them on their packaging.

The FDA has full authority to request and require that manufacturers of these products determine that they are safe. Mainstream food companies fully support the high standard that all claims be scientifically substantiated, truthful and not misleading and that all products be safe. The FDA has already issued warning letters to some companies about their products. The FDA has full authority to regulate these foods. Our members support strong agency regulation in this department. It is important for consumers to be assured that their foods are safe. If the FDA determines that better labeling is needed, then it is within its authority to mandate that, and our members would support it. The FDA has the authority it needs and further regulation is not needed.

The GAO report provides insufficient evidence to justify new regulations. The recommendations would unnecessarily re-regulate foods that already meet stringent federal food laws. Functional foods are already regulated as conventional foods. "Functional foods" is a marketing term.

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