|The New Front Line in Our Fight to Protect Supplements
by Alliance for Natural Health USA
Just before the July Fourth holiday weekend, hoping to limit media attention, the FDA dropped a bomb on dietary supplements.
On July 1, the US Food and Drug Administration (FDA) issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.
Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute "New Supplement" in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements – and if so, under what rules.
Now, 17 years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs; that is, on new supplements. The agency had to do this because it was mandated by the recent Food Safety Modernization Act.
ANH-USA has reviewed the very complicated new regulations in detail. In the hands of an agency charged with regulating supplements fairly – one not hostile to supplements the way that the FDA is – they might be made to work. But in the hands of the FDA, which wants everything – supplements and drugs alike – to go through the vastly expensive new drug approval process, we fear that the new rules will be used to forbid the development or sale of any new supplements – where "new" means anything after 1994, when DSHEA was passed.
FDA Supplement Guidelines a Perversion of Congressional Intent
The NDI notification system that DSHEA outlined was supposed to be about notification, plain and simple, with only occasional response from the FDA. In fact, before this draft guidance was published, Senators Tom Harkin and Orrin Hatch – the two principal authors of DSHEA 17 years earlier – wrote to FDA Commissioner Margaret Hamburg, MD, to underscore their expectation that the guidance be consistent with the intentions of DSHEA. "In DSHEA," they wrote, "Congress made clear that consumers should continue to have access to dietary supplements that meet the law's definition [and] should also refrain from erecting barriers that will inhibit or needlessly delay consumer access to safe products."
Unfortunately, the FDA had other plans for our supplements. By turning what was meant to be a premarket notification system into a preapproval system, the FDA becomes the ultimate arbiter of which dietary supplements will and will not be available.
The FDA does this by simply not "filing" (which means accepting) any NDI notifications it doesn't like. It may be because the notification does not meet rigid FDA specifications. Or it may be for any reason, however arbitrary.
On Course for a European-Style Druglike Approval System
Robert Verkerk, PhD, ANH-USA scientific director and ANH-Europe executive and scientific director, said: "We see the NDI guidelines, modeled on the EU's Novel Food Regulation, as being nothing less than a mechanism to freeze-frame the US natural products industry, and haul it back to its pre-1994, pre-revolutionary state." Like all guidelines, the devil is in the details. DSHEA fully envisaged premarket notification (though not approval) of NDIs; that is, dietary ingredients not marketed prior to October 15, 1994. But it didn't set any hard-and-fast rules over what was required to show their safety. And now, 17 years on, we see where the FDA is taking this. And what we see is an unashamed attempt to blueprint one of the most lethal weapons presently being used in Europe to decimate its natural products industry.
What the NDI guidelines force companies to do, once an ingredient is deemed to fit the NDI classification, is prove its safety before it can be sold. This notion is fundamental, because it moves us away from the long-cherished notion of presumption of safety for natural dietary ingredients, and places the burden of proof on the manufacturer. It actually may sound quite reasonable to some, but the reality is that proving safety is a very complex process – and one that is simply out of reach of most of the smaller companies that have been at the forefront of pioneering the natural health foods revolution since the 1960s.
In Europe, there are two main ways that regulators are forcing products off the market. Either they get declared unlicensed drugs, or they get classified as unauthorized "novel foods." In ANH's experience, of these problems in the EU, the novel food bans are proving at least as important a tool for the regulators as unlicensed drug classifications. Well, now it's the FDA's turn to use this same weapon on its people!
FDA Supplement Guidelines Are a Big, Fat Gift to Big Pharma
As Big Pharma becomes more desperate to boost flagging profits, the industry will likely use this tactic to find new sources of revenue – and shame on the FDA for so blatantly aiding and abetting it!
This coming year, 7 of the world's 20 bestselling drugs will lose their patent protection and can be sold in generic forms. On this list are the top two money-makers ever created: cholesterol-fighting (but overall health-threatening) Lipitor and blood-thinning (but bone-destroying) Plavix. This wave of expiring drugs patents will have unprecedented and devastating effects on the industry bottom line. One drug recently made available in generic form – Protonix, a medication for severe heartburn (again, not a drug that we would use, and especially dangerous when used with the blood-thinner mentioned above) – previously cost about $170 per month when it was still under patent; its generic version now costs $16. With 7 of the top-selling drugs expected to see similarly drastic drops in prices, the drug industry is in a panic – especially considering that there are no new "blockbuster" drugs in the pharmaceutical industry pipeline. Under these circumstances, why not try to turn some supplements into drugs?
Even before the draft FDA's NDI (new supplement) guidelines, supplement manufacturers already faced a "race-to-the-market" threat from the drug companies. DSHEA states that a company cannot market a NDI – that is, a new supplement – if an IND (Investigational New Drug) application for that ingredient has already been filed and research on that ingredient is publicly available (a study published in any scientific journal will do). Bottom line: If a drug company files an IND (drug) application for a natural substance before a supplement manufacturer can meet the onerous NDI (supplement) notification standards and receive FDA approval, the supplement company can never again sell the substance in its natural form.
This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. And it could also happen to P5P – the ultimate form of natural B6 which all other forms of B6 must convert to before being used by the body. Without P5P we would all die; yet the FDA may turn it into a prescription drug.
Wait, there's more.
Any "new" supplement is already at risk of being converted into a drug – and this risk is greatly increased by the new FDA NDI (new supplement) guidelines. But the new FDA guidelines don't stop there. While they encourage drug companies to take natural substances, they forbid supplement companies from selling synthetic botanicals.
What does this mean? "Botanicals" refers to plants. For years, drug companies have studied plants for medicinal uses. If they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance, a new molecule that can be patented and then taken through the FDA as a new drug.
Nothing unfamiliar about this. What is new in the draft FDA NDI (new supplement) guidelines is that synthetic versions of botanicals may never be sold as supplements, only as drugs. In effect, the FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, only synthetics can be patented, and only patented substances can be brought through the hugely expensive FDA approval process.
This is all blatant crony capitalism – a huge gift to the drug industry without any conceivable benefit to the public. There can be no reason for it other than to pad Big Pharma's pockets – a guaranteed monopoly on synthetic botanicals for drug companies to patent, all of which will lead to larger drug company fees' being paid to the FDA.
Given a choice between natural and synthetic, we vote for natural. But that doesn't mean that drug companies should have a monopoly on synthetics. If the FDA has its way, everything we take apart from food would be synthetic, patentable, sold by a drug company, prescribed by a doctor, cost a fortune, and produce a mountain of fees for the FDA itself.
If you have not done so already, please send your message to Congress through our Action Alert Center at www.anh-usa.org
We cannot emphasize strongly enough how very important it is that we fight on these two issues – your access to natural supplements is at stake!
"FDA Guidance for Industry Dietary Supplements: New Dietary Ingredients Notifications and Related Issues" posted in federal register on July 1, 2011 has a 90-day comment period. Read the information about the FDA "Guidance" Statement as titled. Action to prevent this guidance statement from taking effect is needed immediately.
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October 17, 2011