Responding to a Sports Illustrated article published recently called ‘What You Don’t Know Might Kill You’, CRN defended DSHEA, as it and other trade associations have done for 16 years since DSHEA was enacted, and highlighted the powers bestowed in it which the FDA and other agencies had consistently failed to enforce.
Pure trash?
This failure to enforce has allowed a culture of criticism to grow and fed perceptions that the dietary supplements industry is, as Sports Illustrated described it, a “…a Pandora's Box of false claims, untested products and bogus science”.
A blog posted on the Los Angeles Times was no less scathing, stating DSHEA had, “paved the way for a marketplace in which manufacturers of dietary supplements can churn out pure trash.”
In a five-page response to the Sports Illustrated article, refuted the argument that DSHEA had taken away FDA authority. It was rather the other way around, said CRN president and chief executive officer, Steve Mister.
He said misconceptions about DSHEA were perpetuated in the article that stated the regulation had, “razed virtually every barrier to entry into the marketplace.”
“With that premise, the extreme examples the article describes appear to be a product of DSHEA, when in fact, they more likely result from FDA’s lack of enforcement of that law over the past 16 years,” Mister said.
He added: “DSHEA actually provided FDA with new enforcement authority not previously available... Further, FDA never had legal pre-market approval authority for dietary supplements—DSHEA did not change that fact.”
Only since the appointment of Dr Mark McClellan as FDA commissioner in 2002 did the FDA emerge from its “fog of inertia”.
Actions
Since then products like ephedra have been banned by the FDA on safety grounds and warning letters, fines and inspection rates have increased, along with the imposition of Good Manufacturing Practices (GMPs) and adverse event reporting (AER).
The fact 75-days pre-market approval was required for new dietary ingredients was also overlooked by the article. “When FDA chooses to enforce these requirements, they offer considerable market barriers to screen out bad actors,” Mister said, but he noted CRN was not aware of a single occasion a breach of new dietary ingredient notification requirements.
“Every industry has its outliers, the underbelly that ignores the laws, cuts corners in manufacturing and puts profits ahead of long-term confidence of their consumers,” Mister said. “This industry is no exception, but that is not the fault of the law itself. No law works unless it is enforced.”
In 2008, FDA received 1080 adverse event reports, of which 672 were deemed serious. The pharma industry received 526,000 AERs in 2008, of which more than 300,000 were considered serious. Between 1969 and 2002, 75 FDA-approved drugs were removed from the market due to safety concerns.
If the FDA could not enforce DSHEA as it is, there was little chance it would have the resources to police a pre-market registration system.
“Now that FDA has set its regulatory mind to enforcing the law, it has the ability under the law to weed out bad actors—those who are not abiding by regulations,” Mister concluded.
“FDA’s job is to protect the public, and we urge Congress to provide sufficient budgetary funds for the Agency to do its job, rather than wasting time and tax-payers’ money with re-writing laws unnecessarily.”
CRN's full response can be found here.