Herbal remedies are about to face tougher scrutiny in the European Union. As of May 1, a new EU registration requirement for herbal treatments takes effect, addressing potential side effects of many alternative medicines.

The EU defines “herbal medicinal products” as products made from plant substances which may be used to treat illnesses. These cover traditional herbal medicinal products - herbs that have been used for at least 30 years anywhere, including at least 15 years in the EU - that are intended for use without a medical practitioner’s supervision.

The medicines may not be administered by injection. Examples of traditional herbal products are Echinacea and calendula. All medicinal products - and herbs are treated as medicinal - need authorization to be placed on the market in the EU. However, because of traditional herbal medicines’ long tradition of use, the EU introduced the new but simpler registration procedure in March 2004 with the Traditional Herbal Medicinal Products Directive.

Member countries of the EU have had seven years to register traditional herbal medicines. Traditional herbal product manufacturers must provide documentation showing the product is safe in specified conditions of use and that its effectiveness is plausible based on long-standing medicinal use (30 years worldwide, including at least 15 in the EU).

If the makers can prove this, the product does not have to undergo the rigorous safety tests and clinical trials necessary to register other mainstream and non-traditional herbal medicinal products.

Traditional herbal medicinal products not registered by the April 30 deadline may not be sold in the EU. New herbal products will require the same safety tests and clinical trials that are required of mainstream and non-traditional herbal products. The directive does not apply to holistic alternative therapies such as acupuncture or reiki.

The United States hasn't made a similar move to tighten use of herbal remedies and largely regulates them more as foods or supplements.

But Seanna Tully, clinical services manager of the Apothecary at Whole Health Chicago, said she worries the Food and Drug Administration will follow suit in the U.S. because the FDA usually follows Europe’s lead.

A contact at the American Medical Association’s Department of External Communications would not comment on the EU regulations beyond stating the AMA’s 2008 policy on alternative medicines. Courses on alternative medicine offered by medical schools “should present the scientific view of unconventional theories, treatments, and practice as well as the potential therapeutic utility, safety, and efficacy of these modalities,” according to the AMA policy.

Dr. Jack Killen, deputy director of the U.S. National Center for Complementary and Alternative Medicine, said that while many alternative medicinal remedies are very safe, others may not be.

“There are definitely concerns with some traditional herbal medicines interacting with drugs or other herbal medicines,” he said. They may have toxic side effects of their own, or be contaminated by pesticides or other things from the environment.

Another concern of his is about the makers of the herbal remedies. “There are unscrupulous makers who adulterate some of these products with conventional medicines and other drugs,” Killen said.

There are similar issues with mainstream medicines, which have their own side effects or can interact with other medicines a person is taking, Killen pointed out.

Alternative medicine specialists say herbal remedies are generally very safe but can have side effects, especially when taken with other herbs or mainstream prescription medicines.

Micaela Angle is a licensed acupuncturist and manager for the National College of Natural Medicine’s Medicinary in Oregon. The medicinary provides supplements, herbs, homeopathic remedies, tinctures and other products to the public, doctors, and patients of the college’s clinic. She said, in her opinion, there is a lower rate of side effects from herbal remedies - including dietary supplements, herbs, teas, and tinctures - compared to mainstream prescription medicines.

Still, “everything has the potential to cause a side effect,” she said. Depending on the herb, the dosage, and other herbs or mainstream medicines someone is taking, side effects of herbs may range from headache to digestive upset.

“A trained practitioner knows what herbs not to prescribe with something else,” she said. Patients should consult a trained herbal practitioner before taking a product rather than self-treating with products bought in a health store, to limit the risk of side effects, she said.

Angle said the medicinary takes further steps at the National College of Natural Medicine to ensure safety of herbal products by requiring a doctor’s prescription for many herbs.

“We’re trying to support the professionalism of naturopaths and of Chinese medicine,” she said. A naturopathic product may pose a risk depending on the strength of the dose or whether it has been misused in the past.

At naturopathic schools in the U.S., medicinaries usually require prescriptions to sell Chinese herbal medicines. Angle estimated that, at the National College of Natural Medicine, 95 percent of Chinese herbs are prescription products because most Chinese medicines are prepared for people individually depending on their symptoms.

Licensing for herbal practitioners is stringent in the U.S., according to Angle. For instance, after graduating with a master’s degree from an alternative medicine school, people who hope to become specialists in Chinese medicine take a two day-long test through the National Certification Commission of Acupuncture and Oriental Medicine. But each state chooses whether or not to acknowledge the licensure.

Killen and Angle said that different states have different standards for recognizing alternative medicine practitioners. Some states recognize different kinds of practitioners, such as naturopaths, osteopaths, acupuncturists, or chiropractors. Others may allow only one kind of specialist to practice, or none at all. Killen said that in general, states that license professions base their licensing requirements on the standards of national organizations.

In Illinois, medical doctors, osteopaths, chiropractors and registered dieticians can prescribe herbs, but not acupuncturists - even though, according to Tully, they have training in herbs.

“The regulatory framework for herbal medicines in the U.S. is different from conventional drugs” because they are manufactured and marketed according to different governmental standards, said Killen. If someone wants to market an herb as a medicine and claim that it cures a disease, it is considered a drug and must meet certain FDA standards. Herbs marketed as supplements face different standards.

Most herbs are regulated as foods, in the supplement category, not as medicines, according to Tully. Tully said she was not surprised by the stricter rules in Europe because Europe tends to be more restrictive when regulating alternative medicines. She said she expects that the restrictions will create an underground herbal industry in Europe.