Pharmacology and Herbal Supplements for Brain Improvement

The United States Pure Food and Drug Act became law on June 30, 1906. This legislation mandated the federal inspection of meats and banned the sale of adulterated food products and poisonous drugs. In 1938 the Federal Food, Drug, and Cosmetic Act established the United States Food and Drug Administration (FDA). This agency was given the responsibility for ensuring the safety of food, pharmaceuticals, and cosmetics and, subsequently, was empowered to assess and verify drug efficacy. Given these and other legislative mandates, a drug candidate must now undergo years of rigorous laboratory animal and human testing before the manufacturer gains FDA approval for sale to the general public.

Hundreds of millions of dollars are needed to cover the costs associated with meeting FDA criteria for a single, new drug product. Among these requirements is detailed information on its chemical and pharmacological properties. Convincing evidence must be submitted that the compound is safe and efficacious at the recommended dose. Side effects and toxicities must be identified, including information on potential interactions with other drugs that may be taken by the patient. The intended use must be defined precisely on the basis of clinical research results. Data are required on the purity and stability of the manufactured product. After a drug is approved, federal inspectors routinely monitor its production and use to ensure product consistency and appropriate marketing.

Given these safeguards, it is not necessary for consumers to be concerned about the safety and effectiveness of prescription or over-the-counter medications. While not all drugs are effective in all patients, and there can be idiosyncratic responses, consumers can reasonably assume that if an FDA approved product is taken as directed it will likely display some efficacy as a treatment for their condition and that they will be alerted to potential side effects. Accurate information on the limitations of use and possible toxic reactions is usually obtained from the health care provider and is readily available in the manufacturer’s description of the product and in other forums.

The situation is different for herbal supplements. Given their growing popularity in the 1980s, Congress needed to decide whether these products should be subject to federal regulations covering foods or drugs. In the United States this resulted in the Dietary Supplement Health and Education Act of 1994. As this legislation defined these products as food supplements, producers are not required to provide proof of safety or any health benefit before offering them for sale. While a statement regarding safety must be submitted to federal authorities, the burden of proof is on the government to raise questions about possible dangers associated with use. If the government registers no objection within a specified period, the product may be sold. Given the lack of regulation and oversight, those selling such products are forbidden to refer to them as drugs and to advertise any therapeutic benefit. To comply with this requirement, product labels often contain a disclaimer indicating it is not to be used to diagnose, treat, cure, or prevent any disease. As a practical matter, however, broad, misleading claims about the therapeutic benefits of dietary supplements are commonly encountered, especially on the Web.

The number and popularity of these products has continued to expand, with more than $5 billion in sales in the United States in 2009. Because of growing concerns about product contaminations and the quality of the ingredients used to manufacture some supplements, new regulations were enacted in 2003 to allow government inspectors access to company manufacturing records to monitor quality control. However, it cannot be assumed that all herbal product manufacturers routinely undergo such inspection given the number of companies, the fact that many are located abroad, and the shortage of FDA personnel. The absence of federal requirements regarding safety and efficacy, and the minimal manufacturing oversight, leaves the consumer responsible for assessing the potential risks and benefits of these products. Besides a paucity of objective research data, this determination is complicated by the fact that neither the potential user nor the manufacturer can always be sure of the number and type of biologically active constituents in these extracts. This makes it difficult to assess what effect the supplement may have on otherwise healthy individuals, let alone those with a chronic or acute illness, those taking prescription medications, or who are undergoing other kinds of treatments, such as radiation therapy.

When developing new drugs, safety and efficacy issues are addressed by basic and clinical pharmacologists. To this end, pharmacologists consider a number key principles. While this task is simplified when examining a single, purified substance, these same principles can be applied, although to a more limited extent, to plant extracts when deciding whether a product might be of benefit. The information contained in this post is intended to provide a broad overview of these basic pharmacologic principles and to define terms and concepts useful in making an informed judgment about the potential utility of an herbal product. The aim is to help the consumer think like a pharmacologist when considering the possible use of a dietary supplement. Although the quality and quantity of the publicly available research data are limited for these products, an understanding of these principles and terms will enable the consumer to make a more informed decision about the potential value of a particular product.