Compliance Column

As public awareness of healthy eating has grown, so too, has the consumption of dietary supplements. An Institute of Medicine (IOM) study from 2004 entitled “Dietary Supplements: A Framework for Evaluating Safety” reported that that annual sales of dietary supplements in the United States is worth around $16 billion with an average of 1,000 new products being developed each year. Considering the benefits touted in dietary supplement advertisements it’s not surprising that public demand for supplements is soaring. So what exactly are dietary supplements, who controls their efficacy and safety, and are they as effective as we are led to believe?

What exactly is a dietary supplement?

The term dietary supplements suggest that these products merely augment a deficiency resulting from an imbalanced diet. However, the 1994 Dietary Supplement Health and Education Act (DSHEA) defines "dietary supplement" as any product (except tobacco) that contains at least one of the following:

a vitamin,
a mineral,
an herb or botanical,
an amino acid,
a dietary substance "for use to supplement the diet by increasing total dietary intake," or
any concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.

Since DSHEA's passage, hormones including dehydroepiandrosterone (DHEA) and melatonin have also been marketed as dietary supplements.

The definition certainly gives the supplement industry plenty to work with.

In the early 1990’s when DSHEA was being developed, the original intention was to strengthen the ability of federal agencies to combat health frauds. However, following four years of wrangling and lobbying from the health-food industry critics believe that the final version of DSHEA, which defined dietary supplements as a separate regulatory category from drugs, severely limited the ability to correctly regulate these products.

Debate continues over whether DSHEA protects the public or protects the supplement industry by providing such lose regulatory control over some very potent products.

Who regulates dietary supplements?

As a consequence of DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as foods and not as drugs in the United States. This difference means that manufacturers of supplements are not required to meet the same standards of safety and effectiveness that are required for prescription and over-the-counter medications. However, increasing numbers of dietary supplement suppliers are making therapeutic claims for their products even though these claims have not been assessed by the FDA. While illegal to state claims on the product labels, the supplement industry is structured to ensure that the public learns of "medicinal" uses through other routes. This includes promoting the individual ingredients of the products in books, magazines, newsletters, booklets, lectures, radio and television broadcasts, oral claims made by retailers, and the Internet. According to survey data studies conducted by the IOM the majority of consumers believe that supplements are either reasonably or completely safe. The difference in the regulatory control of drugs and foods clearly puts the pharmaceutical industry at a disadvantage compared to supplement manufacturers. The lack of control over the safety and quality of food supplement products also poses potential risks for patients taking these products while under the impression that they are safe.

Approved claims

The FDA do approve some claims made for food supplements where a strong link, based on scientific evidence, between a food substance and a disease or health condition can be demonstrated. These approved claims can state only that a food substance reduces the risk of certain health problems - not that it can treat or cure a disease. Two examples of approved claims are: "The vitamin folic acid may reduce the risk of neural tube defect-affected pregnancies," and "Calcium may reduce the risk of the bone disease osteoporosis."

Dietary supplement labels may also bear claims that describe the effect of a substance in maintaining the body's normal structure or function. The FDA does not review or authorize these claims. An example of such a claim is, "Product X promotes healthy joints and bones." When a dietary supplement is promoted with a claim like this, the claim must be accompanied with the disclaimer, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease."

Time to act

Pressure is steadily mounting for the FDA to tackle the issue of food supplement regulation; to level the playing field for the pharmaceutical industry and provide protection for the public. At the end of last year, the FDA announced three major regulatory initiatives designed to further implement the DSHEA. These initiatives included a regulatory strategy and a draft guidance document for industry.

For the regulatory strategy, the FDA plan to work collaboratively with its Federal and other partners to improve the evidentiary base used to make safety and enforcement decisions about dietary supplements. The guidance document provides information on the amount, type and quality of evidence a manufacturer should have to substantiate a claim made under 403 (r)(6) of the Federal Food, Drug, and Cosmetic Act. The document does provide manufacturers some flexibility in the precise amount and type of evidence that constitutes adequate substantiation. The FDA will also implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements.

In Europe more draconian measures have been established to control the supplement industry. The European Parliament passed the "EU Directive on Dietary Supplements," which classifies vitamins as medical drugs rather than as food supplements. The directive was passed in 2002 and granted a three year transition period for products already on the market. By the end of this year, every EU country will be required to implement the directive. The directive lists just 28 vitamins and minerals, and 112 sources from which they were derived, that can be sold legally for use in food supplements.

Supplements under attack

Not everyone is happy with the idea of the FDA weighing in on the supplement industry or with products being removed from sale in Europe. A challenge to the directive has been mounted in the European Court of Justice in Luxembourg by trade associations representing health-food manufacturers and health stores. They argue that the directive is unnecessary, will restrict choice and cause many companies to go out of business. Headlines scream of confrontation between big pharma and the natural health movement and restrictions on consumer choice.

Hatchet job - take a dose of GMP

In January, a panel of the IOM released a report entitled “"Use of Complementary and Alternative Medicine (CAM) by the American Public". In the report the IOM recommended amending DSHEA to give the FDA more control over food supplements. The core of the panel's recommendation is straightforward: any treatment - whether it's a prescription drug or a natural remedy - should fall under the same standards of testing, quality and truthful advertising. The report allows for "grandfathering" in supplements proven safe, such as vitamins, and it suggests that a variety of testing methods could be permitted.

It is extremely difficult to gain agreement over what approach is appropriate for food supplements and the IOM report has elicited a fierce response. The American Herbal Products Association (AHPA) responded saying that the report was based on erroneous assumptions and discredited references.

The President of the Council for Responsible Nutrition (CRN), Dr. Annette Dickinson, went further saying that “The dietary supplement chapter is an unwarranted hatchet job". She continued that "Dietary supplements are not drugs, have never been drugs, and will never rightly be considered drugs.”

The general consensus among the food supplement industry is that DSHEA is an effective law that but that it has not been fully implemented largely due to a 10 year wait for the FDA to establish good manufacturing practices (GMP) for dietary supplements. Whereas the initiatives outlined by the FDA last year are promising, it is doubtful whether FDA has the manpower, expertise or budget to successfully deal with food supplements in a way that keeps every one happy.

Part 2 of this special edition of the P.I.L.S. Compliance Column will continue to look at recent developments in the dietary supplement industry and observe some of the complex and confusing advertising standards that exist.