Lawmakers Mull Regulating Dietary Supplements

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Lawmakers Mull Regulating Dietary Supplements

September 10, 2001 3:46 pm EST

By Adam Entous

WASHINGTON (Reuters) - The chairman of a Senate panel said

Monday he may seek tighter regulation of the $27 billion

dietary supplements industry, citing alleged marketing

abuses by one of the largest herbal-remedy companies and its

owner, who was pardoned by former President Bill Clinton.

Glenn Braswell, who was pardoned in January for a 1983 mail

fraud conviction stemming from his sale of a product that he

falsely claimed cured baldness, invoked his Fifth Amendment

protection against self-incrimination and refused to answer

the questions of Sen. Breaux, chairman of the Special

Committee on Aging.

After the hearing, Breaux, a Louisiana Democrat, said

legislative action may be needed to protect seniors, many of

whom use anti-aging products and other dietary supplements

as an alternative to traditional treatments or to save money

on expensive prescription drugs.

" We're going to explore it, " Breaux told Reuters, referring

to legislation that would give federal regulators new tools

to ensure the safety of supplements and keep companies from

making false claims about their products.

An estimated 60 percent of Americans take some form of

supplement with no apparent health problems. But lawmakers

and health experts say some anti-aging products can pose

health risks, particularly to the elderly, and unlike new

prescription and over-the-counter drugs, U.S. law does not

require them to undergo premarket approval for safety and

efficacy.

The General Accounting Office, which conducts investigations

for lawmakers, warned the Senate committee that seniors may

be particularly at risk of " physical harm from the use of

anti-aging alternative medicine products. " Breaux said he

was " disturbed " by the GAO's findings.

The Senate hearing focused largely on the marketing

practices and advertising claims of Braswell and his GB Data

Systems Inc., the holding company for at least 10 businesses

selling a wide range of dietary supplements.

The former chief financial officer of GB Data,

O'Neil, told the committee that Braswell's products -- which

claim to treat everything from constipation to anxiety --

" could not possibly deliver what is promised in the

advertising. " The process used to recruit customers, O'Neil

added, was " flawed and laden with lies and deception. "

The Senate panel had subpoenaed Braswell, who allegedly paid

Clinton's brother-in-law to press for his pardon, to testify

along with Ron Tepper, editor of the Journal of Longevity.

Committee aides allege that the journal is used as a

" marketing and advertising tool " for Braswell's products.

Both were sworn in by Breaux, but they refused to answer

questions. Committee aides said they were urged by counsel

to invoke their Fifth Amendment protection against

self-incrimination in light of an ongoing investigation by

federal prosecutors and the Internal Revenue Service (IRS).

" These are clearly cases of 21st century snake oil

salesmen, " Breaux said. " They sell slick-looking

advertisements that look like medical journals but take

advantage of the elderly by putting both their health and

their finances at risk. It is clearly fraudulent and it

simply will not stand. "

During the hearing, experts warned of the health risks

associated with taking certain herbal and non-herbal

supplements along with prescription drugs and other

FDA-approved medication.

St. 's Wort, for example, may reduce the effectiveness

of certain antiviral drugs. Other compounds used in

supplements can cause vomiting, breathing problems,

convulsions, and even coma and death when used in large

amounts.

Breaux was critical of existing laws that put the " burden "

on the FDA to prove that products are unsafe before they can

be removed from the market. That contrasts to the drug

market where manufacturers must establish safety and

long-term effects to get FDA approval. " It seems to me we

have a serious problem which needs to be addressed, " he

said.

While Breaux said legislative changes appeared necessary,

other senators said the onus was largely on the FBI, the

Food and Drug Administration and other regulatory agencies

to crack down on abuse using existing laws.

" Clearly we must enforce the law, remove the threat of

dangerous products from the market, and bring to justice

criminals who prey on the frightened and hopeless, " said

Sen. Larry Craig of Idaho, the ranking Republican on the

committee. " At the same time, we should remain wary of calls

for expansive regulations that may restrict an individual's

freedom to make his or her own health decisions. "