Supplement guidelines stuck in red tape

[Guest guest]

Supplement guidelines stuck in red tape

By Todd Zwillich

WASHINGTON, Mar 19 (Reuters Health) - Dietary supplement makers awaiting

manufacturing regulations were told on Monday by a Food and Drug Administration

official that the rules are finished but are being held up by the Bush

Administration' s Office of Management and Budget.

The industry is expecting rules that lay down manufacturing standards for makers

of dietary and herbal supplements. The regulations are supposed to help the

industry, plagued in recent years by reports of inconsistently manufactured and

contaminated products, to standardize how supplements are made.

The FDA has been working on the proposed rules for at least two years. The

regulations were sent to the Office of Management and Budget where they have

been " caught up in the change of administrations, " agency official

told members of the National Nutritional Foods Association, a supplements

industry group.

" It was our intent that (the regulations) would be gone by now. It really is

frozen in time at this point, " said , who directs FDA's office of

nutritional products, labeling, and dietary supplements.

The White House did not return calls at press time.

The industry has suffered over the years from frequent media reports detailing

inconsistencies between dietary supplement labels and what ingredients those

supplements actually contain. The FDA found wide variations in the consistency

of products containing ephedra, an amphetamine-containing herb that was blamed

by the agency for hundreds of adverse health effects in the late 1990s.

The industry has faced scrutiny in the last few months as it became known that

some dietary supplements contain cow brain and spinal cord tissue, thought to

pose a risk for mad cow disease, and it's human form, new variant

Creutzfeldt-Jakob disease. Meanwhile, Internet sites like consumerlabs.com

continue to test dietary supplement products and publicize the results of

products that fail to meet label claims.

" A disappointing fraction of products have not passed those tests, " said Dr.

Annette Dickinson, vice president of scientific and regulatory affairs at the

Council for Responsible Nutrition.

NNFA and other groups have moved to implement their own manufacturing practice

guidelines in an effort to protect consumer confidence in dietary supplements.

But such guidelines do not carry the weight of federal law and only apply to

NNFA members, about half the entire dietary supplement industry, according to

Seckman, NNFA's CEO.

Manufacturers are reluctant to spend time and money implementing strict

manufacturing guidelines of their own for fear that they will have to be changed

to meet the federal standards when they come out. In the meantime, many dietary

supplement makers are growing inpatient.

" We're pretty tired of the media beating us up for lousy quality, " said

D. Israelson, executive director of the Utah Natural Products Alliance.

The House Government Reform and Oversight Committee is scheduled to hold

hearings Tuesday looking at FDA's regulation of dietary supplements and industry

quality issues.