This news from last week provided context for the introduction, also last week, of the Dietary Supplement Full Implementation and Enforcement Act of 2010, by industry political champions Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA). The bill “completes the unfinished business of full implementation of DSHEA,” according to industry guru Loren Israelsen.
Natural Products Association’s John Gay described the legislation as “putting more cops on the street, plain and simple.” All good news, right?
That is, until you understand the context: Last week also featured a high-stakes grilling of the functional ingredients industry in the US Congress and in print media. In the US, a Government Accountability Office undercover investigation recorded retailers telling tall tales about supplements. The same investigation found some botanicals with measurable – yet within the safe threshold – levels of heavy metals. It also discovered unsafe levels of pesticides.
The US Institute of Medicine three weeks ago now turned up the heat, advocating the FDA apply the same health-claims assessment methods for foods and supplements as it does for pharmaceutical drugs.Nevermind the conceit that pharma’s products are meant to treat diseased people while supplements’ products are meant to prevent diseases by keeping people healthy in the first place. What’s that old Chinese saying – a doctor fails who prevents a patient from becoming sick in the first place?
And, we might as well note that Forbes magazine piled on, using that old epithetical saw: snake oil.
Lastly, let us not forget the goings-on in Europe, which is denying virtually every proposed health claim. All of which leads us to start asking: Can the industry save itself? Or will government regulators and the media stifle innovation (not to mention free speech) to the extent that only diligent consumers surfing PubMed (and, ahem, NPIcenter) will be able to discover the research showing the nutrients by and large are safe and efficacious – and clearly are not drugs?
GMPs, AERs and new laws notwithstanding, the meme that used to read the US supplements industry is “unregulated” is now shifting to either “lightly regulated” or, more to the point, “contaminated and/or adulterated.” It is this latter point that puts the onus squarely on manufacturers and suppliers – and the brokers and farmers and importers that serve them.