Athletes live in an ambivalent relationship with nutritional supplements. With compelling evidence for performance optimization and recovery using targeted supplements in addition to a regular diet, athletes have long sought the “magic pill” that will cure aches and pains or enhance performance. The darker side of supplements occasionally rears its ugly head in the form of media-induced hysteria over the latest drug scandal or doping positive or, more seriously, widespread and legitimate health concerns about easily available dangerous supplements.

With five years spent in the chemical and biotech industry as a Ph. D. level chemist in an FDA regulated environment, I have a solid basis for the real-life information presented in this series of articles on nutritional supplements, FDA oversight, and the narrow path between safety, testing and consumer availability. I have also raced at an elite level triathlete for five years and recognize the unique needs faced by both age-grouper and professional endurance athletes. Slowtwitch.com has commissioned me to write these articles based on the above background and my penchant for dutiful scientific research. I’m going to approach this topic beginning with the regulatory fundamentals and moving into testing and doping issues. A significant amount of this part’s information comes from the FDA which is, after all, the expert. What follows is part one.

WHAT IS A DIETARY SUPPLEMENT?

The U.S. Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labelled a dietary supplement. The government body with an oversight of the entire food, drug and nutritional supplement industry is the United States Food and Drug Administration (FDA).

WHAT IS FDA'S ROLE IN REGULATING DIETARY SUPPLEMENTS VERSUS THE MANUFACTURER'S RESPONSIBILITY FOR MARKETING THEM?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

The final FDA ruling of June 22, 2007 helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label. The standards prescribe practices to ensure quality during manufacturing, labeling, and storage of dietary supplements.

cGMPs (current Good Manufacturing Practices) are intended to establish a comprehensive system of process controls, including documentation of each stage of the manufacturing process, that can minimize the likelihood of, or detect, problems and variances in manufacturing as they occur and before the product is in its finished form. These process controls that are a part of cGMPs are essential to ensure that the dietary supplement is manufactured, packaged, held, and labeled in a consistent and reproducible manner. Manufacturing according to cGMP means that the manufacturing process incorporates a set of controls in the design and production processes to assure a quality finished product. cGMPs specific to dietary supplements are necessary to help ensure that these products have the identity, purity, strength, and composition that meet specifications established in the master manufacturing record and that they are not adulterated. The specifications were intended to ensure that adulterated and misbranded dietary supplements would not reach the marketplace

Ensuring quality in dietary supplement cGMP, in part, means that you produce what you intend to produce. Manufacturers must plan what they intend to produce, institute adequate controls to achieve the desired outcome, and ensure that the controls work so that the desired outcome is consistently achieved. Thus, for example, the manufacturer decides on the identity, purity, strength, and composition of the dietary supplement it manufactures. The focus of cGMP is on process controls to ensure that the desired outcome is consistently achieved, and not on the inherent safety of the ingredients used (which is addressed by other statutory prohibitions).

HOW CAN CONSUMERS INFORM THEMSELVES ABOUT SAFETY AND OTHER ISSUES RELATED TO DIETARY SUPPLEMENTS?

It is important to be well informed about products before purchasing them. As it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase. In part 2 of this series, I will discuss supplement testing and certification stamps.

DOES FDA ROUTINELY ANALYZE THE CONTENT OF DIETARY SUPPLEMENTS?

The FDA does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law.

WHO VALIDATES CLAIMS AND WHAT KINDS OF CLAIMS CAN BE MADE ON DIETARY SUPPLEMENT LABELS?

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission (FTC).

WHY DO SOME SUPPLEMENTS HAVE WORDING (A DISCLAIMER) THAT SAYS: "THIS STATEMENT HAS NOT BEEN EVALUATED BY THE FDA. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE"?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.

IMPLICATION OF THE FINAL FDA RULING OF JUNE 22, 2007 FOR TRIATHLETES:

The final FDA ruling is good news for all consumers as it significantly tightens regulations within the industry.

• Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labelled.

• The rule will give consumers greater confidence that the dietary supplement they use has been manufactured to ensure its identity, purity, strength, and composition.

• The rule addresses the quality of manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used.

WHAT IS THE cGMP FINAL RULE?

• The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (cGMPs) for dietary supplements.

• The current good manufacturing practices (cGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.

• The cGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labelling, and distributing them in the U.S.

• The rule establishes cGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.

• The requirements include provisions related to:
o the design and construction of physical plants that facilitate maintenance,
o cleaning,
o proper manufacturing operations,
o quality control procedures,
o testing final product or incoming and inprocess materials,
o handling consumer complaints, and
o maintaining records.

• To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final cGMPs is effective in June 2008 for large companies. Companies with fewer than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

HOW WILL THIS AFFECT MANUFACTURERS (AND THE QUALITY OF THE PRODUCT YOU CONSUME)?

• Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers have an essential responsibility to substantiate the safety of their products and for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading.

• The cGMPs will help to ensure manufacturers produce unadulterated and properly labelled dietary supplements.

• Under the cGMP rule, manufacturers are required to:
o Employ qualified employees and supervisors;
o Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labelling and holding;
o Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
o Establish and use master manufacturing and batch production records;
o Establish procedures for quality control operations;
o Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;
o Keep a written record of each product complaint related to cGMPs; and
o Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

• Examples of product quality problems that the rule will help prevent are:
o dietary supplements that contain ingredients in amounts that are greater than those listed on the label dietary supplements that contain ingredients in amounts that are less than those listed on the label
o wrong ingredient,
o other contaminant (e.g., bacteria, pesticide, glass, lead),
o foreign material in a dietary supplement container,
o improper packaging, and
o mislabelled

Based on the increased FDA guidance within the supplement industry, it is likely there will be some transitional issues and increased costs that will be passed along to consumers in order to comply with the new regulations. Pundits may say this new move is too little, too late. Uncomfortably ensconced in the region between drug-like regulations and the pre-FDA free for all, the nutritional supplement industry is poised for a revolution.

In a future instalment, I will discuss sources of contamination, testing and drug detection limits as well as screening and certification programs for banned substances in supplements. Stay tuned.

Suggested reading:

- FDA final rule
- Summary document for consumer guidance on Nutritional Supplements