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Regulation and Quality Control of Dietary Supplements

Richard Ko, PharmD, PhD, is the founder of Herbal Synergy, a consulting company that specializes in the food and drug regulations of the United States. Dr. Ko was a Research Scientist (Food and Drug Scientist) at the California Department of Health Services, Food and Drug Branch for 16 years. In his government role, he was actively involved in regulating dietary supplements and investigating herbal products related injury and death. This speaker lectured for the UCLA summer course MED 180, "Introduction to Integrative East-West Medicine for Health and Wellness," which took place from June 23-August 1, 2014.

In this lecture, Dr. Richard Ko of Herbal Synergy discusses the regulation and quality control of dietary supplements, which is a highly important topic in regard to patient and consumer safety. According to Dr. Ko, herbal products can be regulated by multiple U.S. regulatory agencies, including the U.S. Food and Drug Administration (FDA).The FDA is a federal agency under which there are two laws that regulate herbal medicine: the Federal Food, Drug, and Cosmetic Act, and the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Herbal products imported to the U.S. may be categorized as cosmetics, pharmaceutical drugs, over-the-counter drugs, or dietary supplements (i.e., food, tea). Under the DSHEA, dietary supplements can be either a food or drug. Dr. Ko states that putting herbs in the food category makes it more likely that herb dissemination will expand. Federal versus state jurisdiction exists for herbal medicine, with the former regulating only imported and exported products, and the latter products regulating those that do not cross state lines. As 80 to 90 percent of herbs that we get in the U.S. are imported, most are under federal jurisdiction. Traditional Chinese medicine (TCM) herbs can be considered dietary supplements, drug products, or cosmetic products, depending on the claims and disclaimers on the labels. The Federal Food, Drug, and Cosmetic Act focuses on the intended use of the product, which needs to be indicated on the label. The DSHEA serves the same purposes as the Federal Food, Drug, and Cosmetic Act, but also reviews animal extracts, particularly those used as oral digestives.

Substance such as herbs which are classified as dietary supplements need to be manufactured under Good Manufacturing Practices (GMP) guidelines, and thus their labels need to have the product’s intentions and ingredients clearly labeled. On a dietary supplement label, all the ingredients have to written in common terminology, and include statements indicating that 1) the claims have not been evaluated by the FDA and 2) the product is not intended for diagnoses or treatment. Drug labels, on the other hand, may include a claim to treat or prevent symptoms or diseases. While there is no requirement to place expiration dates on dietary supplement labels, if these dates are included, data is needed to support these claims.

Regulations are also implemented to ensure the safety of imported products. Dr. Ko mentions that some herbal products may be prohibited even though they are not unsafe. This is because they may not meet standardized heavy metal, microbial, and/or contaminant levels, though these amounts may technically be needed for the product or its ingredients. However, other herbs may turn out to be unsafe due to adulteration, sometimes intentionally done. The clinical case examples Dr. Ko described involved high levels of herbs – making the product unsafe, heavy metal addition, and substitution with different herbs that may look similar to the original herbs. In all, since dietary supplements have the potential to both help and harm depending on their use, practices surrounding regulation, categorization, labeling, and quality control of such products require our keen attention, and continued research of these products (such as those of TCM origin) is essential.


Click here to read more about the MED 180 course.


Lecture summary generated by Harini Kompella, Volunteer Writer, UCLA


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