SEP 27, 2000, M2 Communications - On July 18, the Center for Science in the Public Interest (CSPI) called on the Food and Drug Administration (FDA) to ban the sale of more than 75 functional food products, claiming they are "spiked with illegal ingredients" and are labeled with "false and misleading claims." Their allegations have been repeated many times over past several months, as the story has received strong media coverage. The Herb Research Foundation (HRF) believes that consumers are neither endangered nor cheated by functional foods.

Food additives vs. food ingredients

For instance, AriZona Green Tea with Ginseng makes no label claim of any kind about the benefits of either green tea or ginseng, yet it is one of the products CSPI would like to see pulled from shelves. CSPI says the FDA does not list ginseng as an accepted food additive, so it is against the law to include it in foods. This complaint is irrelevant and inaccurate. Food additive laws, according to Congressman Delaney, who introduced the law in 1958, are meant to apply "to food chemicals only" (i.e. preservatives, emulsifiers, coloring agents, etc.), not to whole foods like herbs. FDA lists ginseng as a safe food ingredient, not an additive, with a demonstrated, acceptable history of safe use-just like vanilla extract. Both ginseng and green tea are on the FDA`s list of substances Generally Recognized As Safe (GRAS) by food safety experts. If manufacturers wanted to introduce a new chemical food additive, with no historical use as a food ingredient, they would have to petition the FDA for approval. However, none of the herbal ingredients targeted by CSPI are novel food ingredients, nor does the FDA consider them unsafe. All are approved for use in dietary supplements, which are regulated as foods.

HRF believes that herbal extracts which are legally and safely sold in tablets or capsules or as liquid dietary supplements are not suddenly dangerous when added to foods like fruit smoothies.

Misleading claims vs. statements of nutritional support

According to Connecticut`s Attorney General, who joins CSPI in criticizing the food industry on the functional food issue, the "outlandish and ridiculous claims" on functional food labels are hoodwinking consumers. The implication that some legal loophole leaves the FDA and Federal Trade Commission powerless to remove deceptively labeled products from shelves is simply not true.

Healthful foods have always been permitted to bear statements of nutritional support, as long as the claims are truthful and not misleading. These familiar statements-such as the claim that milk "helps build strong bones and teeth" help educate people about nutrition. The statement "with Red Panax Ginseng for increased energy" (on Hansen`s "Power" sparkling beverage) is no different.

Ginseng does increase endurance, just as echinacea "supports the immune system," and St. John`s wort "elevates mood," when quantities sufficient to support the claim are included in the food.

* HRF believes functional food manufacturers can most effectively educate consumers with specific statements based on solid science and directions that tell people how much of the functional food is required to achieve the benefits claimed.

HRF recommends that health benefit claims on functional food labels be accompanied by the amount of active herbal ingredient per serving.

* HRF agrees that false or poorly documented claims should not be used to market functional foods.

Too little active ingredient vs. too much

Functional food critics complain that the amount of herbal extract in most functional foods is too small to have a therapeutic effect. In some cases this may be true, but it is clearly possible to include effective amounts of some herbal ingredients to confer health benefits and thus make a more healthful food. HRF believes that consumers can distinguish between marketing language and health benefit claims, and that the FTC and FDA have adequate authority to assure safe products and truthful labeling.

CSPI presents kava as an example of a "dangerous" ingredient because it has been implicated in two arrests for driving while intoxicated. Both instances involved Pacific Islanders who had spent the better part of a day drinking traditionally prepared kava tea, achieving twelve or more times the recommended daily dose. HRF President Rob McCaleb points out that such a large dose would be "humanly impossible to consume" with Snapple "Moon" tea, or Hansen`s "d-stress" sparkling beverage, because we cannot drink enough of these liquids to achieve an overdose. If these manufacturers attempted to add doses of kava that would raise a legitimate concern, their products would be both prohibitively expensive and unpalatable. The Council for Responsible Nutrition has verified that there have been no reports of problems with functional foods, including herb overdoses.

Potential interactions vs. sensible labeling

Another concern is that herbal ingredients will interact with drugs, or prove unsafe for pregnant women, children, or people with medical conditions. "An herbal ingredient is no more likely to interact with a drug than the food it was added to," replies McCaleb. Foods react with drugs, too. For instance, grapefruit juice inhibits the metabolism of some drugs. While drinking grapefruit juice actually has caused a patient to overdose on his heart medication, no herb has been implicated in a case of actual drug failure-even though herbs are typically consumed in a supplement form much more concentrated than that found in functional foods.

If a functional food package contains active amounts of an herbal compound, HRF recommends the label contain the same cautions as those found on herbal dietary supplements.

Protecting allergic consumers vs. choice for all consumers

CSPI attempts to bolster its argument by stating "Echinacea can cause allergic reactions." HRF would like to point out that peanuts, dairy products, and shellfish can cause allergic reactions far more severe and more frequently than any known herb. Functional foods manufacturers must state clearly all the ingredients their products contain, which allows allergic consumers to avoid them.

Unknown dangers of heating herbs vs. thousands of years of herbal tea use

CSPI`s clouded understanding of this issue is also apparent from their warning "It is unknown...what happens when they [herbs in functional foods] are heated" (lawyer Ilene Ringel Heller, as quoted by ABC News). Actually, most everything we know about what happens to herbs in the body was studied by first heating them. Most of the herbal ingredients targeted by CSPI (ginseng, echinacea, guarana, nettle, kava) have been used and enjoyed-hot-as teas or boiled "decoctions" for hundreds or thousands of years. The manufacture of herbal extracts-the form of herbs used in clinical trials and often in functional foods-involves heating the liquid extract to produce a powder.

These spray-dried extracts have been subjected to thousands of clinical and laboratory trials that confirm their safety.

"Iron fortified!" vs. "with Ginseng!"

"The addition of specific nutritional supplements to foods is nothing new," McCaleb emphasizes, citing calcium, iron, and vitamin C as ingredients commonly added to food. "It is encouraging to see manufacturers putting more healthful foods on the market."

The concerns CSPI voices about herbal ingredients-allergic reactions, possibility of overdose, interactions with drugs, overstated claims-are equally applicable to vitamin and mineral ingredients. Yet the public recognizes that vitamin and mineral fortification does not threaten public health or consumer confidence, and that people may choose not to buy fortified products. Foods "fortified" with herbs are no different.

Conventional foods with herbal supplements vs. herbal supplements in food form

It seems that the true issue is not herb safety or deceptive advertising.

These complaints have arisen because it is unclear whether functional foods are to be regulated as conventional foods or dietary supplements in food form.

Each category has a separate set of regulatory requirements, neither of which neatly fits functional foods.

CSPI would better serve the public interest by promoting nutrition education, instead of trying to keep functional foods from consumers.

(From HealthWorld Online)