FDA warns against spiking dietary supplements

The Food and Drug Administration warned the nation's dietary supplements industry Wednesday against spiking its products with steroids,
prescription drugs and other prohibited substances.
The warning was the latest salvo in a long-running battle between federal regulators and an industry that is held to far less rigorous health and
safety standards than those imposed on makers of pharmaceuticals and medical devices – thanks in part to powerful friends in Congress.
Unlike drugs, dietary supplements don't have to be proven safe before being sold and manufacturers can make general claims about health benefits.
Testing showed what the FDA termed "an alarming variety" of prescription compounds tainting supplements, including anticoagulants,

anticonvulsants, nonsteroidal anti-inflammatory drugs (NSAIDs) and beta blockers, the agency said.
The FDA urged supplements producers to keep a closer eye on the production and distribution of their products and urged them to report suspect
activity to a specially designated email address or to FDA's office of criminal investigations.
Since 2007, nearly 300 products marketed as supplements have been found to contain potentially dangerous or illegal ingredients, most of them
sold as diet, weightlifting or sexual enhancement aids, FDA principal deputy commissioner Joshua Sharfstein said in a telephone call with
reporters.
More than 80 bodybuilding compounds, 70 sexual enhancement aids and 40 weight loss supplements have been recalled under FDA prodding,
according the agency's letter to industry.
"This is progress, but we cannot claim success," Sharfstein said. The presence of tainted products "undermines consumer confidence in legally
marketed supplements," he said.
Consumers should be wary of supplements sold as alternatives to prescription drugs, or as legal alternatives to steroids, preparations sold via the

Internet or marketed primarily in a foreign language, Sharfstein said.

Tainted supplements have been linked to dozens of reports of adverse events including strokes, liver and kidney damage and deaths, according to

an FDA spokeswoman, who said that she did not have specifics.

FDA believes the number of adverse events is likely underreported for a variety of reasons including a desire to avoid embarrassment over use of

bodybuilding or sexual enhancement products, she said.

Among the potentially dangerous substances found in some supplements was fenfluramine, a pharmaceutical ingredient removed from the market
for safety reasons. Others contained controlled substances including benzodiazepines and anabolic steroids, the FDA said.
Just last week, the FDA warned consumers against using Man Up Now, a sexual enhancement aid that contains a chemical similar to sildenafil,
the active ingredient in Viagra.
In October, the agency told consumers to stay away from Slimming Beauty Bitter Orange Slimming Capsules because they contained
sibutramine, a prescription-only stimulant with Spanish language packaging, which was passed out a month earlier at Mexican Independence Day
festivities in Chicago.
Sharfstein was joined by the leaders of five major supplements trade associations, who framed the problem as the fault of industry outsiders,
describing them as "hijackers," "pirates" and "people who work in the shadows."
"Every time there's a news report of a tainted supplement, it's bad for the industry," said Ivan Wasserman, a Washington attorney, who represents supplement makers.
Wasserman said many of the tainted products are sold by "smaller, Internet-based off-brands."
But a leading consumer advocate termed industry portrayal of the problem as a diversion from the real problem with supplements.
"Even if not contaminated, in many cases they do not have evidence of safety and effectiveness," said Sidney Wolfe, of Public Citizens' Health
Research Group.
Unlike drugs, dietary supplements don't have to be proven safe before being sold and manufacturers have wide latitude to make health claims.
The industry has long had a powerful friends on Capitol Hill, chief among them
The industry's political patrons include Sen. Orrin Hatch, R-Utah, whose state is home to a sizeable chunk of the supplements industry and who sponsored the 1994 legislation that gave supplement makers their sheltered regulatory niche.
The FDA's letter notes that manufacturers and distributors are responsible for ensuring that their products comply with the law and urged them to email, TaintedProducts@fda.hhs.gov or the portal