These are just some of the threats the 1994 Dietary Supplements and Health Education Act (DSHEA) has had to face in its 15-year existence and which it continues to face today with a challenging decade ahead.
But according to Loren Israelsen, an industry veteran who has worked at the front lines of US dietary supplements legislation for more than three decades, the law that created rules specific to the US dietary supplements industry for the first time is, “in pretty good shape and still in one piece”. A fact a lot of people thought would not be the case 15 years down the line.
“I would give DSHEA’s implementation a mixed grade if it was an Olympic diving event,” said Israelsen, now executive director of the United Natural Products Alliance (UNPA), which he established in Utah in 1991 to represent dietary supplements manufacturers among others (then called the Utah Natural Products Alliance). “There would be some 6.5s and some 9s.”
Ephedra
DSHEA has ridden out some pretty tough times such as the ephedra issue from 2003 and 2004 that led at first to heightened calls that DSHEA was incapable of controlling the dietary supplements industry, but which became its premier demonstration of enforcement grunt.
Ephedra products that had been linked to high-profile pro sports deaths as well as many adverse events among the public who had taken to using the stimulant herb for weight management purposes, were banned by the Food and Drug Administration in 2004, proving DSHEA had teeth and regulators the will to enforce.
Today, it is the seemingly growing problem of steroid contamination that is drawing a lot of heat to DSHEA. Senate hearings have been called to discuss the issue.
“There is a focus on steroids and sports supplements and internet supply but the thing is these are not supplement issues. These products are drugs, not dietary supplements but because these practices are going on DSHEA has become something to blame for other problems.”
While acknowledging that the FDA was issuing more warning letters and was better funded than it had been in a long time, Israelsen said more had to be done to, “enforce the law with respect to internet claims.”
But there was not a whole lot of difference between 1994 and 2009 in terms of forces for and against, he observed, except that, “senior staff who have worked for a lot of DSHEA’s critics have moved into government positions at the FDA and FTC.”
GMPs
While GMP implementation has been criticized for being unclear and poorly enforced, Israelsen said they were off to a good start.
“The inspection rates are rising as the increased Obama funding filters down through the FDA and that is advancing down the supply chain management,” he observed. “Adverse event reporting is becoming better understood and the final phase of the GMP regulation kicks in in June so there is a lot of work to do.”
That June deadline will see the smallest players come under the remit of GMP regulations and Israelsen said measures were being considered, in consultation with the FDA, to assist, “the smaller guys”.
These included co-op buying to reduce small-lot costs; shared analytic skills and resources and shared GMP costs.
He said GMPs were benefitting from the University of Mississippi GMP training program which was delivering better qualified GMP inspectors, coupled with greater transparency in ‘483’ inspection reports that were becoming available publicly so everybody could learn from them.
Botanicals and particularly, powdered botanical extracts, remained a weak spot but the FDA’s re-hiring of Carl Reynolds, a man with respected grass roots GMP knowledge, would help the situation.
“Carl is great in the field and will be a fine conduit between FDA and industry.”
NDI/ODI
Israelsen said the FDA needed to clarify its position with regard to new dietary ingredients (NDI) and old dietary ingredients (ODI) – those that predate DSHEA. “We need a properly functioning ODI archive and that is not the case,” he said. “The FDA does not recognize the current ODI list as authoritative because in its view the documentation is not adequate.”
“What is needed is an industry/FDA agreement on what constitutes verifiable documentation of ODI status,” Israelsen said. “Further, there will be discussion about changes from ingredients available in 1994 and what is currently sold in 2009. It is expected that FDA will raise the question of whether a change in such things as dosage ranges and potency will have an effect on ODI status. These are the salient questions.”
Amidst all the challenges Israelsen sees progress to a long-held vision of a fully functioning law serving a vibrant and effective industry.
“There is movement in the right direction and for the first time we are getting close to seeing an outline of what a well-implemented DSHEA looks like.”
He added: “It has taken a lot longer to achieve than I expected.”
Correction: This article has been amended because the original erroneously stated Israelsen was critical of DSHEA when it is the pace and scope of its implementation that he is critical of. It also said he was an author of the law, when he in fact advised on its development, conception and implementation. It also clarifies his position on old dietary ingredients (ODIs) and the forces for and against DSHEA.