Saturday, September 10, 2011

Busting the Anti-Supplement Myth Machine

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Pick up any newspaper, scan your daily news feed, glance at the TV --- and you’re sure to be hit by the latest “news” about dietary supplements: how they don’t work, how they’re all tainted with contaminants and laced with pharmaceuticals; and how their manufacturers are out to get us!

The truth, however, is far more reassuring than the headlines make out.  Go ahead, Google “dietary supplements” with the name of any of the big networks or newspapers, anything from ABC News to the Chicago Sun-Times or CNN, you name it.

I did: and in top search listings for seven of the country’s leading newspapers and five of its major networks, nearly 70 percent of the coverage is skeptical and cautionary about dietary supplements.

In fact, our self-appointed guardians of public health (whether wielding Senatorial powers or using a journalist’s pen) almost always forget to discuss those tablets and capsules that are profoundly dangerous and largely toxic: prescription drugs. Each year, prescription drugs injure approximately 2.2 million and kill at least 100,000 Americans.

With today’s nutritionally bankrupt diet over 52 percent of Americans take dietary supplements, a rate that is expected to keep growing. So, if supplements are so popular, and good for us, why, we ask, are they getting such a bum rap? Good question.

Feeding the undeservedly bad reputation is a confluence of several factors, including: historically poor government enforcement against a small number of fringe operators; general misunderstanding of how well-regulated the dietary supplement industry actually is; and media feeding frenzies related to high-profile cases that have little, or nothing, to do with the dietary supplement industry, aside from actually showing the regulations effectively working.

Therefore, it’s up to all of us to be myth-busters on a daily, or weekly or monthly basis — so that one day our guardians of public health will have no choice but to acknowledge what we already know: the power and promise of safe dietary supplements that are produced by a responsible, well-regulated dietary supplement industry: in other words, the facts.

It’s time that conventional researchers begin to design studies that build on vitamin research of the last 50 years rather than attempt to poke holes in what we already all know: vitamins promote health, reduce disease, and help people live longer … and better.

And it’s high time that the media write a new story about dietary supplements, one based on science and facts not on cynicism and misreporting, because the story they have been writing of late is getting old fast. 

Friday, September 09, 2011

The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun

By James J. Gormley
According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.

U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.

I am sure that the FDA is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone --- calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) --- could reduce healthcare costs by over $24 billion.

These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements --- such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on ---- it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.

Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.

It is baffling as to why the FDA would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.

Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.

Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.

The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.

Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice sitting down.

In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:
I invite all of you to join with and support the critical work being done and about to be rolled out over the coming weeks.

While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.

While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.

Our defining health-freedom battle of the first century of this new millennium has begun.

Thursday, September 08, 2011

Emord on NDI Guidance

From Nutraingredients-USA

By Elaine Watson

If sufficient pressure is exerted by key members of Congress, it is not beyond the realm of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan Emord.
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The Gormley Files - Blogged