More than 20,000 herbal (botanical) and other natural products are available in the United States. The term natural has been associated with herbal products because they are primarily derived from plant sources. Herbal products are marketed as dietary supplements in the United States and are not required to comply with safety and efficacy regulations imposed on drug products. Manufacturers cannot make claims of curing conditions, but they can make claims of improving structure or function. The FDA can allow a qualified health claim if there is scientific evidence to support it. Before 1994, the FDA attempted to propose stricter regulations for the herbal supplement industry. However, aggressive lobbying by the dietary supplement industry and thousands of letters from the general public to Congress blocked the proposed regulations.

Today, herbal products are regulated by the Dietary Supplement Health and Education Act (DSHEA), which exempts vitamins, minerals, and botanical products from meaningful FDA regulation. Before this act, the manufacturer had to prove that a herbal product was safe and effective. Today, the FDA must prove that the product is unsafe. The manufacturer needs only to notify the FDA of any efficacy claims. Changes in the Federal Food, Drug and Cosmetic Act in 2006 now require the supplement industry to report all serious dietary supplement-related adverse drug effects to the FDA. In 2007, the FDA drafted regulations that would require supplement manufacturers to test for purity and to ensure that their products do not contain contaminants and to verify that the contents within the package matched the labeling information. These regulations were approved in August of 2007, and were to be phased in over the next 3 years, and and completely in place by the end of 2010. However, when the final bill, Dietary Supplement Full Implementation and Enforcement Act of 2010, was introduced it was referred back to committee twice. Many in Congress felt that the Bill was over regulating the dietary supplement industry. However, the proposed legislation is needed to regulate this growing industry.

Package Labeling

Other aspects of the DSHEA prevent the use of therapeutic claims on the label. All herbal products must be labeled as dietary supplements. These products cannot have labels such as “for treatment of hypertension.” However, the labels can contain claims of effects on the structure or function of the body. Thus a natural product could be said to “increase immunity” without a comment about what that might mean to a person’s health. Another rule is that information may be provided that may not be necessarily scientific, but it cannot be false or misleading. Again, the responsibility for proof of misleading labeling is in the hands of the FDA.

The DSHEA required that the following phrase must be included on each natural product’s label: “This product is not intended to diagnose, treat, cure, or prevent any disease.” This phrase is also required in the advertising of such herbal products. (It is said really quickly in television and radio ads.) Another requirement is that “information” must be physically separate from the natural product. The product would be on one shelf and the information would be placed in another aisle. It is unclear what benefit separating the information from the product would serve other than having gotten the Act passed. Health food store employees help customers obtain the literature and associate it with the products to determine their purchase choices.

Safety of herbal and nutritional products

Many consumers consider herbal products to be nontoxic or free of side effects because they are often called “natural” remedies. Most of the herbal products available contain ingredients that have profound pharmacologic effects. Some products may have potential therapeutic effects, and the vast majority have adverse effects and drug interactions. Since 1994, the FDA has investigated more than 800 reports of adverse reactions with more than 100 different ephedra alkaloid-containing products. Adverse effects included insomnia, nervousness, tremor, headaches, hypertension, seizures, arrhythmias, heart attack, stroke, and death. More than 50% of the adverse effects were reported in people younger than 40 years, and another 25% occurred in people 40-49 years of age. In 2004, following reports of cardiovascular events with ephedra (ma huang), the FDA issued a regulation prohibiting the sale of all dietary supplements containing ephedrine alkaloids and warned consumers to stop taking the product. A Utah supplement company challenged the ban, stating that the FDA was trying to regulate a food supplement as a drug. Unfortunately, a federal judge ruled in favor of the supplement company.

Because some herbal products have pharmacologically active ingredients, the dental health professional should acknowledge this fact and treat any herbal product as a drug. Any use of herbal products by the patient should be noted in the patient’s chart. Table 27-1 lists examples of selected herbal products, their adverse effects, and implications for the dental hygienist.

Oral Adverse Effects

The most common adverse oral and dental effects of herbal medications are many and include dysgeusia, gingival hyperplasia, intraoral hemorrhage, necrosis, oral candidiasis, oral ulceration, stomatitis, tooth discoloration, and xerostomia, according to research conducted at the Case Western Reserve University School of Medicine. St. John’s wort, an herbal supplement used to treat mild depression, causes xerostomia, just as prescribed antidepressants do. Oral ulcers, lip irritation, swelling, and gingival bleeding have been reported with the use of feverfew. There have been reports of increased gingival bleeding with ginkgo; and oral and lingual dyskinesia with the use of kava. Other reports include tongue numbness and taste changes with the use of echinacea.

Drug interactions