Hatchet job on the Hill

CRN's Steve Mister testifies before Congress.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.

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's 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.

Highlights of the testimony during the May 26 hearing of Senator Kohl's Special Committee on Aging

Senator Herb Kohl (D-Wis.) Opening Statement
The number of scientific studies conducted on the safety or efficacy of herbal supplements is limited, and, unlike pharmaceutical drugs, these supplements are not subject to FDA approval before being marketed and sold. In addition, claims made about these products in advertisements are subject to only limited regulation. We'll hear today that legitimate concerns remain about the industry. A Government Accountability Office investigation uncovered both improper advertising and marketing of dietary supplements, as well as the existence of contaminants in certain products.

Greg Kutz, Managing Director, Forensic Audits and Special Investigations, US Government Accountability Office, Washington, DC
In 2000, we reported that consumers did not consistently receive clear, scientifically supported information concerning products' health benefits so they could make informed dietary choices. Most recently, we expressed concern that weaknesses in the regulatory system may increase the likelihood of unsafe products reaching the market.

Our investigation found examples of deceptive or questionable marketing and sales practices for dietary supplements popular among the elderly. The most egregious practices included suspect marketing claims that a dietary supplement prevented or cured extremely serious diseases.

The levels of contaminants found do not exceed any FDA or EPA regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern. However, because EPA has not set pesticide tolerance limits for the main ingredients of the herbal dietary supplements we tested, the pesticide contaminants exceed FDA advisory levels. FDA agreed that 16 of the 40 supplements we tested would be considered in violation of US pesticide tolerances.

Tod Cooperman, President, ConsumerLab.com, White Plains, NY
Based on tests of over 2,000 dietary supplements representing over 300 different brands, we find that one out of four has a quality problem.

A major cause of these problems is the reliance by some manufacturers on cheap, nonspecific tests that overstate the amount of actual ingredient in raw materials and supplements.

Good Manufacturing Practices (GMPs) are now required of most supplements manufacturers to help ensure batch-to-batch uniformity. However, "bad" products can, and are, being made under these "good" practices because the GMPs do not include standards for purity and ingredient identity.

However, in nearly every supplement category that we test, we do find products that meet high quality standards, showing that this is achievable.

Charles Bell, Programs Director, Consumers Union, Yonkers, NY
Another important concern is assuring the quality of imported ingredients that are used in dietary supplements. China has come to dominate the vitamin raw material market over the last decade. Obviously, these concerns are not just limited to China. US health and safety officials must assure the safety of all imported products that are used in the US, particularly food, drugs and supplements, regardless of the country of origin.

Steve Mister, President and CEO, Council for Responsible Nutrition, Washington, DC
We want to assure you that our industry condemns adulterated products and false, misleading or deceptive marketing practices or activities engaged in by a very small minority who have damaged the reputation of the responsible industry that comprises the vast majority of supplements sold in this country. The responsible supplement industry has a demonstrated track record of providing high-quality products to its consumers and of active lobbying for stronger regulatory guidelines.

By simply enforcing the current law, if the agencies devoted greater focus and had greater resources to fully implement it, these incidents could be further reduced. And when the pending Food Safety legislation (S. 510) is enacted, legislation which our industry supports, there will be additional laws in place.

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