In a ‘perspectives’ article in the New England Journal of Medicine, Dr Pieter Cohen, assistant professor of medicine at Harvard University, said: “The new guidance represents an important step in the right direction; the FDA has decided to implement the law before a public health crisis forces it to do so.
"However, I do not believe the FDA has gone far enough.”
NDI draft guidance an ‘important step in the right direction’
He goes on to argue that the FDA should not accept evidence of historical use in lieu of experimental data as proof of safety. And where there is no documented history of use, both animal and human testing should be required.
“The Dietary Supplement Health & Education Act (DSHEA) explicitly requires the FDA to assess the reasonable expectation of safety of new ingredients...And it is impossible to do so scientifically without experimental data."
Pre-market approval system is only way to protect consumers
But ultimately, said Dr Cohen, who called for a pre-market approval system for dietary supplements on the Dr Oz show last week, strengthening the guidance would only achieve so much.
“Even if the guidance is strengthened and aggressively implemented, fundamental flaws in DSHEA, such as the lack of a preapproval review process for all supplements, will continue to limit the FDA's ability to ensure that dietary supplements are safe.”
‘There should be pre-approval for botanical ingredients marketed with structure/function claims’
Speaking to NutraIngredients-USA last night, Dr Cohen said tougher rules would benefit the trade’s responsible players: “In my opinion, the current regulatory framework creates a facade of safety for all supplements. This creates perverse incentives to introduce poor quality and even illegal products.
“Instead, industry, consumers and physicians would benefit from a regulatory framework that favors ethical manufactures producing high-quality products rather than punishing them.
"Today, if someone wants to produce pharmaceutical-quality botanical ingredients, I suspect they would not be able to get a good return on their investment because the consumer would have no way of distinguishing the high-quality from low-quality products.”
Asked about pre-market approvals, he said: “DSHEA is working quite well for vitamins and minerals. However, when we talk about promoting botanical ingredients with structure/function claims that's when I have some serious problems with the current regulatory framework.
“I do think there should be pre-approval for botanical ingredients marketed with structure/function claims.”
CRN: We’ve heard it all before...
Predictably, his comments have not gone down well in the supplements trade.
Duffy MacKay, vice president, scientific and regulatory affairs at the Council for Responsible Nutrition (CRN) said he had heard it all before.
“His personal call for pre-market approval legislation for our industry is not new... If the supplement industry were subjected to pharmaceutical industry-like regulation, consumers would bear the burden of increased costs and reduced availability to a wide variety of products.
“Additionally, a pharmaceutical-like regulatory framework is inappropriate for dietary supplements because supplements do not have the same immediate and dramatic effects as pharmaceuticals, and in general, they have a wider margin of safety.”
Meanwhile, Dr Cohen’s comments about spiking at the beginning of his article reinforced the erroneous impression that tougher NDI guidance was critical to safety, despite the fact that supplements with undeclared active pharmaceutical ingredients were GMP enforcement issues, said MacKay.
“The product Dr. Cohen references in his commentary, by law is illegal and not a dietary supplement…This is not a problem that will be solved by more stringent NDI guidelines.”
AHPA/AIBMR: Supplements have remarkable record of safety
American Herbal Products Association (AHPA) president Michael McGuffin said: “It is remarkable that Dr. Cohen both takes the position that the law has not been properly implemented and that if it is not implemented in accordance with his vision 'the public health consequences will be significant'.
"By this rationale, the public health consequences should already be obvious. Yet the dietary supplement class has a remarkable record of safety.”
Dr Alex Schauss from contract research organization AIBMR Life Sciences added: “Where are the bodies that should compel the supplement industry to spend hundreds of millions of dollars on human studies to prove the safety of its products to the satisfaction of the FDA or its critics?”
GOED: Why shouldn’t FDA accept evidence of historical safe use?
Dr Harry Rice, vp regulatory & scientific affairs at the Global Organization for EPA and DHA Omega-3s (GOED), added: “It's not clear to me why Dr. Cohen believes the FDA shouldn't accept evidence of historical use in lieu of experimental data, particularly since that is the way DSHEA was written.”
Dr Claire Kruger, a toxicologist and chief executive of consultancy Spherix Health Sciences, said: “The documentation of long history of use in food as a standard by which safety of an ingredient can be established is not new to the DSHEA legislation.”
But she added: “There must be a bridge between the intended conditions of use of a dietary ingredient and the historical use. If these differ significantly, one can utilize appropriate scientific studies to build this bridge.
“When properly executed, data from these safety studies can be used in risk assessments to extrapolate the impact of chemical composition, dose, frequency and duration to the safety of ingestion of the dietary ingredient.”
NPA: Regulatory oversight of trade has become stronger
Finally, Natural Products Association (NPA) president Jeff Wright pointed out that regulatory oversightof the trade “has gotten stronger in recent years with the implementation of adverse event reporting and good manufacturing practices inspections and that the draft guidance “goes well beyond the scope of the law” it was designed to clarify.
He added: “The industry needs clarity for the rules governing the NDI process, but those rules must be consistent with DSHEA.”
Click here to read Dr Cohen’s article, which was published on January 25 at NEJM.org (10.1056/NEJMp1113325).