An eye on dietary supplement issues
By Andrew Halpner, Phd and John Hathcock, PhD

During recent months, individuals in the dietary supplement industry have speculated about the regulatory fate of supplements in the United States in the near future.

A quick check of the Internet reveals that much debate has focused on how Codex might limit our ability to buy and sell supplements.

While it is now apparent that implementation of Codex guidelines in the United States is a premature concern, it is critical to recognize that serious threats to the dietary supplement industry from potential U.S. legislation need to be watched closely.

As a brief background, the Codex Alimentarius — Latin for “Food Code” — was established in 1963 by two U.N. groups: the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).

The commission is the decision-making body, but the recommendations are developed in its numerous committees. The main goal of this commission has been to develop food standards to help maintain fair practices in international trade and to protect the health of consumers.

Over the last few years Codex has been developing new guidelines for vitamin and mineral supplements, and in July of 2005 it adopted the Draft Codex Guidelines for Vitamin and Mineral Supplements. Codex is beginning to work on standards to implement the guidelines.

The supplement guidelines address packaging and labeling, sources of nutrients, and maximum levels, to be set based on risk assessment. (The specific vitamins and minerals allowed and their limits are not yet established.)

The United States is one of 172 member countries that participate in Codex, and the standards adopted are applicable to international trade, especially those controlled by World Trade Organization (WTO) agreements.

SETTING CODEX INFORMATION STRAIGHT

However, one thing that Codex guidelines do not impact is U.S. domestic laws and regulations governing dietary supplements. Unfortunately, in the months leading up to the adoption of these guidelines, many alarming e-mails and Internet articles were circulated that suggested or directly stated that these guidelines would limit consumer access to dietary supplements in the United States, and a few asserted that “supplements would be swept from the shelves in July 2005.”

These assertions are not correct, and there is no prospect that WTO agreements will have such impacts in this country. The United States is a sovereign country, and standards adopted by Codex do not become U.S. law for the regulation of dietary supplements — unless our government decides to do that through our legally required, very public, procedures.

Our access to and the regulation of dietary supplements is based on the Dietary Supplement Health and Education Act of 1994 (DSHEA) — not Codex guidelines. For changes to be made that would affect the manner in which consumers have access to dietary supplements, a change to U.S. law would be needed or the FDA would have to adopt those guidelines through the notice-and-comment rulemaking process required by the Administrative Procedures Act.

All three major trade groups within the dietary supplement industry, including the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA), and the American Herbal Products Association (AHPA), as well as the FDA agree with this position.

The biggest impact the Codex guidelines may have for U.S. companies is on their ability to export products to countries that have more stringent limits.

Several important issues remain active in the Codex nutrition committee: the scientific basis for health claims, nutrient reference (that is, labeling) values, and application of risk analysis to nutrition issues (such as the development of standards for maximum contents of nutrients in supplements).

It is important to understand, however, that while Codex will not directly affect U.S. supplement sales, it is very possible that DSHEA may be altered in the future by legislation in the United States, for reasons that have nothing to do with Codex.

LEGISLATIVE CONCERNS

Numerous House and Senate bills have been introduced over the past few years that seek to make significant changes to DSHEA, some of which may be improvements to the current law, and some of which could negatively impact the industry.

Among the issues are:

• Pre-market approval. Some discussion calls for pre-market approval of supplements, but news about several prescription drugs demonstrates that such requirements do not guarantee safety.

• Adverse event reporting. Another topic of debate has been the creation of an adverse event reporting system (AER). It is fairly well agreed that our industry should have some system of adverse event reporting; however, the best mechanism by which to achieve the reporting of events and how the data will be handled once they have been reported has yet to be determined.

Legislation that was proposed by Dick Durbin (D-Illinois) in 2003 in the form of S. 722, the Dietary Supplement Safety Act, among other things would have required manufacturers to report adverse events and would have allowed the FDA to prevent the sale of any supplement based on just a single reported event regardless of whether it was causal in nature.

This legislation could have seriously harmed the dietary supplement industry and severely limited the access of consumers to dietary supplements. Fortunately, this bill is no longer active.

While adverse event reporting is an important topic, it needs to be dealt with in a sensible manner. It is interesting to note that, currently, only pharmaceutical companies, not doctors, are obligated to report adverse events from drugs.

• Redefined ‘unreasonable risk.’ Another bill that could significantly alter the dietary supplement industry is HR 3156, known as the Dietary Supplement Access and Awareness Act introduced in 2005 by Susan Davis (D-California).

This bill would essentially cause dietary supplements to be regulated as drugs, and would change the “unreasonable risk” clause of DSHEA, thereby altering the FDA’s burden of proof with respect to what it believes is an unsafe dietary supplement.

The result would make it much easier for the FDA to remove a dietary supplement ingredient from the market. This bill has been referred to the House Subcommittee on Health, and fortunately, due to its unproductive overreach in ways that do not increase safety, may not make it very far.

• Additional regulatory bills under consideration. House bill 2485 is the Full Implementation and Enforcement Act of 2005, introduced by Dan Burton (R-Indiana). It would provide additional funding for full implementation and enforcement of DSHEA as it currently exists.

House bill 3937 introduced by John Sweeney (R-New York) and S 1137 introduced by Charles Grassley (R-Iowa) both classify DHEA as a controlled substance and would therefore prevent DHEA from being sold as a dietary supplement.

It is interesting to note that these bills categorize DHEA as an anabolic steroid even though DHEA is an adrenal steroid and does not possess the anabolic properties of other steroid hormones. Nonetheless, DHEA would disappear from shelves in the United States if these bills succeed. Both of these bills are currently in judiciary committees.

It is clear that the landscape is changing and we need to keep a close eye on proposed legislation and how it might impact our industry. Some changes may strengthen and improve our industry while others could potentially limit access to scientifically supported, health-promoting dietary supplements.

Andrew Halpner, PhD, is vice president of Product Development and Technical Services at Douglas Laboratories. He can be reached at ahalpner@douglaslabs.com. John Hathcock, PhD, is vice president of Scientific and International Affairs at the Council for Responsible Nutrition. He can be contacted by phone at 202-204-7962.