Essentials of Nutrition for Sports

From The Medical Letter

29

Supplement Problems Millions of people take herbal products and other dietary

supplements.

The Law

In 1994 the US Congress passed the Dietary Supplement Health

and Education Act, which was intended to keep the FDA from regulating vitamins and he

rbal products as drugs.

The law permits the continued marketing of dietary supplements

sold before October 15, 1994 (defined as vitamins, minerals, botanicals, amino acids and substances such as enzymes, organ tissues, glandulars and metabolites) without the review or approval of any government agency.

To market a new ingredient, a manufacturer must notify the FDA

and demonstrate that it is reasonably expected to be safe.

Health claims can be made on the label—provided the claim also

includes a disclaimer saying that the product is not intended to diagnose, treat, cure or prevent any disease.

All ingredients must be listed on the label. The FDA can remove adulterated or mislabeled products from

shelves, but the burden of proof (and discovery) is entirely on the government.

Manufacturers and distributors of dietary supplements are not

required to record, investigate or

forward to the FDA any reports

they receive of injuries or illnesses that may be related to use of their products.

Quality

The Physicians’ Desk Reference indicates which herbal drugs

are recommended by the German Commission E, a quasi-governmental agency that publishes monographs on these drugs. The monographs generally do not includ

e references. Potency and purity

standards are available in th

e German Pharmacopoeia and

Pharmacopoeia Europa.

Some drugs sold as dietary supplements in the US are sold as

prescription drugs in Europe.

US pharmaceutical firms that have tried to manufacture

pharmaceutical-grade dietary supplements that meet the same Good Manufacturing Practices (GMPs) used to prepare prescription drugs have found that the cost of doing so made their supplements too expensive to compete with much less expensive products already on the market.

GMPs for dietary supplements in the US are still under

development.

Some Specific Concerns Aristolochic Acid

In 1991 and 1992, about 100 wo

men in Brussels who had taken

Chinese herbs for weight loss devel

oped rapid deterior

ation of renal

function. Biopsies showed fibrosing interstitial nephritis. At least 70 of these patients have required dialysis or transplantation, and 18 have developed urothelial cancer.

The cause proved to be aristolochic acid, a known nephrotoxin

from an herb probably included in the product by mistake.

Laboratory analyses by the FDA have detected aristolochic acid

in botanical products and dietary supplements sold in the US.

29 From The Medical Letter. Vol 44. Issue 1140 September 30, 2002. Reproduced with special permission. Nutrition for Sports, Essentials of 150