FDA warns nation’s dietary supplements industry against spiking
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 and beta blockers, the agency said.
The FDA urged supplement producers to keep a closer eye on the production and distribution of their products and to report suspect activity to a specially designated e-mail address or to the 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 to the agency’s letter to the 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, and those 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.
The 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.
Capsules with Spanish-language packaging were passed out a month earlier at Mexican Independence Day festivities in Chicago.
Sharfstein was joined by the leaders of five major supplement 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 were 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’s political patrons include Sen. Orrin G. Hatch (R-Utah), whose state is home to a sizeable chunk of the supplement 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 e-mail TaintedProducts@fda.hhs.gov or the portal of FDA’s office of criminal investigations, https://www.fda.gov/ICECI/CriminalInvestigations/default.htm, with information about tainted products.