Core provisions

Botanical products (medicinal herbs), vitamins, and minerals are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA)—a bill that exempts these products from meaningful FDA regulation. The DSHEA created a special category for nutritional supplements that exempts them from the scrutiny applied to other foods. The DSHEA also states that products not already sold as drugs can now be sold as dietary supplements. Put another way, if a manufacturer is willing to call its product by another name—“dietary supplement” rather than “drug”—the product can qualify for regulation under the DSHEA, thereby avoiding regulation under the more stringent Food, Drug, and Cosmetic Act. As discussed in Chapter 3, the Food, Drug, and Cosmetic Act requires that conventional drugs—both prescription and over-the-counter agents—undergo rigorous evaluation of safety and efficacy prior to receiving FDA approval for marketing. The DSHEA imposes no such requirements on “dietary supplements.” That is, dietary supplements can be manufactured and marketed without giving the FDA any proof they are safe or effective. All the manufacturer must do is notify the FDA of efficacy claims. If a product eventually proves harmful or makes false claims, the FDA does have the authority to intervene—but only after the product had been released for marketing. Furthermore, in order to challenge a claim of efficacy, the FDA must file suit in court; the challenge cannot be made through a simple administrative procedure. As you might guess, the DSHEA was created in response to intensive lobbying from the multibillion-dollar dietary supplement industry, which wanted to minimize government oversight.

Package labeling

The DSHEA does impose some restrictions on labeling. All herbal products must be labeled as “dietary supplements.” In addition, the label must not claim that the product can be used to diagnose, prevent, treat, or cure a disease. In fact, it must state the opposite: This product is not intended to diagnose, treat, cure, or prevent any disease. However, the label is allowed to make claims about the product’s ability to favorably influence body structure or function. Put another way, the label can insinuate specific benefits, but can’t make overt claims. By way of illustration, labels can bear statements like these:

But labels can’t bear statements or terms like these:

If all of this sounds like semantic hair splitting—it largely is. Furthermore, regardless of what the label says, common sense says that people will take herbal products with the intent to prevent or treat disease.

Under the provisions of the DSHEA, there is no assurance that a product actually contains what the label proclaims: The package may contain ingredients that are not listed, or it may lack ingredients that are listed. These shortcomings and others have been addressed by the Current Good Manufacturing Practices ruling, issued by the FDA in 2007 (see below).

Adverse effects

With dietary supplements, as with conventional drugs, the manufacturer is responsible for safety. However, the similarity ends there. Under the DSHEA, a product is presumed safe until proved hazardous. Furthermore, the burden for proving danger lies with the consumer and the FDA. With conventional drugs, opposite logic and regulations apply: Drugs are presumed dangerous until rigorous testing by the manufacturer reveals an absence of serious toxicity. Because of this system, the number of dangerous drugs that reach the market is kept to a minimum. Ask yourself, “Which product would I be more comfortable using—one that has been tested for adverse effects before I take it, or one that is evaluated for toxicity only after it caused me harm?”

Impurities, adulterants, and variability

The DSHEA does not address the issues of impurities, adulterants, or variability. As a result, dangerous products have been allowed to reach consumers. A few examples illustrate the problem:

As discussed below, the Current Good Manufacturing Practices ruling, issued by the FDA in 2007, should prevent the sale of such products in the future.

Other provisions

DSHEA directed the Secretary of Health and Human Services to establish an office within the National Institutes of Health to focus on research regarding CAM. In response, the Secretary created the National Center for Complementary and Alternative Medicine mentioned above.

DSHEA allows retail stores to display promotional material to inform consumers about health-related benefits of products, as long as the material is not false or misleading, and is not displayed close to the product itself.

Current good manufacturing practices ruling

In June 2007, the FDA issued a set of standards to regulate manufacturing and labeling of dietary supplements. These standards, referred to as Current Good Manufacturing Practices (CGMPs), are designed to ensure that dietary supplements be devoid of adulterants, contaminants, and impurities, and that package labels accurately reflect the identity, purity, quality, and strength of what’s inside. In addition, the label should indicate not only active ingredients but also inactive ingredients. The CGMPs also mandate that manufacturers establish quality-control procedures, with the objective of preventing mislabeled, underfilled, or overfilled formulations; variations in tablet size, color, or potency; and contamination with drugs, bacteria, pesticides, glass, lead, and other potential contaminants. Unfortunately, even with the new standards and rules, there is still no assurance that dietary supplements will be either safe or effective—but at least we will have improved confidence regarding package contents.

Dietary supplement and nonprescription drug consumer protection ACT

This act, passed in 2006, mandates reporting of serious adverse events for nonprescription drugs and dietary supplements. The following events should be reported: deaths, hospitalizations, life-threatening experiences, persistent or significant disabilities, and birth defects. Manufacturers and distributors must report these to the FDA within 15 days. Reports can be filed by telephone or by mail, or through the MEDWATCH program (see Chapter 7).

A comment on the regulatory status of dietary supplements

Unlike conventional drugs, herbal products and other dietary supplements are not regulated for either safety or efficacy. Many of these products have constituents that can produce profound pharmacologic effects, both beneficial and adverse. Nonetheless, reliable information on clinical effects is largely lacking. Congress does not allow conventional drugs to be dispensed in the absence of extensive testing, but has made an exception for the supplements. This is both irrational and dangerous. After all, whether you ingest ephedrine in the form of a pill or in the form of Ma huang, it’s still ephedrine, and it’s still going to have powerful effects. Clearly, herbal products should be evaluated and regulated in essentially the same manner as conventional drugs. An editorial in the New England Journal of Medicine (339:839–841, 1998) addressed this issue with eloquence. Here’s the concluding paragraph: