How Are Herbal/natural Products Regulated?
The difference between herbal/natural products and approved drugs is their regulatory status. Prescription products (for example, morphine) and nonprescription or over-the-counter (OTC products such as senna tablets) must meet strict requirements. The manufacturer must provide:
- • scientific evidence to prove that the product is safe and effective;
- • proof that it follows good manufacturing practices (GMP) in a clean (sanitary) facility that meets all the quality control standards set by the Food and Drugs Administration (FDA) in the United States or Health Canada in Canada; and
- • full label disclosure to indicate medicinal and nonmedicinal ingredients and directions for safe use that include cautions and contraindications.
Scientific evidence requires that the product undergoes careful scrutiny to see whether it is of benefit in treating or curing a given medical condition. This involves treating people in a carefully designed and controlled study that is monitored by health professions to see whether the product is safe and whether it works (i.e., is effective). These studies are referred to as double-blind placebo-controlled clinical trials. This is how researchers determine the effects, side effects, and adverse reactions of a product. If the product is shown to be of benefit, the information or evidence from the study is forwarded to the FDA for further scrutiny and approval for marketing.
If the product is deemed safe, effective, and compliant, it receives a unique Drug Identification Number (DIN) that is clearly printed on the product label. This allows the public to know that they are consuming a product that has been evaluated as being safe and effective for a given medical condition.
In the United States most herbs are sold as "dietary supplements" under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under this law they are considered safe, unless proven unsafe by the FDA. In other words, the manufacturer does not have to prove the product is safe. Rather, it is up to the government to prove the product is harmful. This is in contrast to prescription and nonprescription products that must be proven safe and effective by the manufacturer before they are marketed.
The DSHEA prohibits making medical claims on dietary supplement labels, but it allows for publications to be used in connection with their sale. Therefore, products are required to bear the words "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." The FDA does not scrutinize dietary supplements or literature used to promote their sale. This waiver serves to warn the public that the product or literature has not been approved as a regulated drug.
With a similar twist, in Canada most herbs are sold as a "food" without any labeled disclosure, health claim, or quality control. Marketing a product with a health claim places it under the category of "drug." This would require meeting strict requirements under the "drug" part of the Food and Drugs Act of 1953. Selling it as a "food" avoids any testing for safety and efficacy. Unfortunately, this leaves all consumers and health professionals wondering about the quality, safety, and efficacy of the product.