Why the Cost of Supplements Is Likely to Soar (Within the Next 12 Months)

Posted By Dr. Mercola | September 14 2011 

By Dr. Mercola

S.1310: Dietary Supplement Labeling Act of 2011, introduced at the end of June by U.S. Senator Richard Durbin (D-Illinois) is, using Byron J. Richards' words, "an alarming regulatory nightmare that is trying to treat vitamins as if they are drugs."

Its stated purpose is to:

"… improve the safety of dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements."

As is typical of most diabolical laws, it initially sounds harmless enough. But there's more. Durbin's bill goes hand-in-hand with new FDA regulations that amend the definitions for new dietary ingredients (NDI's), and together, they can threaten your health and freedom of choice, and further serve to strengthen the fatally flawed paradigm of health and medicine.

We've seen proposed legislation that sorely threatens your health and well-being before, but this time they're really trying to hit the alternative health field, and your right to take control of your own life, hard.

It's Not about Safety, It's about Profits

Whose profit, you might ask?

Why, the pharmaceutical industry, of course. Vitamins, minerals and herbal supplements have a tremendously safe track record. Drugs are known to cause well over 100,000 deaths per year when taken as prescribed.

For comparison, look at the latest statistics available from the U.S. National Poison Data System, which covers acute poisonings. In 2007, 1,597 people reportedly died from drugs. Meanwhile there was not one single fatality caused by a vitamin or dietary mineral supplement that year. Yet, Durbin and the FDA want you to think that they're just acting in your best interest. Nothing could be further from the truth!

Up to this point, the FDA has had to prove a supplement unsafe in order to take action against it, but now they want the supplement industry to prove the safety of what in many cases amount to food, before they can reach the market.

Why add an extremely costly testing and approval process for compounds that are inherently safe? Well, an obvious side effect of these proposed regulations will be the elimination of small and medium sized companies, which in turn will drive up costs while at the same time reduce your access to historically safe nutritional products. The end result is that fewer people will use supplements to improve their health; driving them back into the extremely profitable fold of conventional medicine and drugs.

Byron J. Richards writes:

"The elimination of health options is required for the control of a population, while the preservation of health freedom is a leading indicator of the overall freedom within a society… [T]he control of health options is as important as the control of food and money.

… Big Pharma influences Republicans by aligning itself as a corporate conglomerate that is too big to fail, one that should be free of prudent safety regulations or reduction in grotesquely inflated prices. It fights against drug safety at every turn, while at the same time lobbying to pass laws that lock in sales or eliminate its competition.

The media plays along, as Big Pharma is a wonderful source of advertising dollars that are in no small part made possible by taxpayer funding of Big Pharma drug sales. While Big Pharma sees many aspects of the dietary supplement industry as competition, it is also the case that many pharmaceutical companies are in some aspect of the dietary supplement industry, often as raw material suppliers.

Big Pharma does not want to see the dietary supplement industry eliminated, it wants to see the small and medium sized independent businesses in the dietary supplement industry eliminated and it wants to own the industry. Their key strategy to accomplish this at this time is to lobby to pass costly laws and regulations which they can comply to and which other smaller, independent companies cannot. "

The Second Part of an Orchestrated Attack

Back in the early 1990s, the FDA threatened the availability of dietary supplements to the point that consumers staged a massive revolt, which resulted in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The law specifically protects your access to dietary supplements by classifying them as foods, not food additives or drugs, and it grand-fathered in dietary supplements that were already in use as of 1994. Only novel ingredients introduced after October 15, 1994 are required to seek FDA approval.

Now, along with Durbin's bill, the FDA has concocted new proposed mandates regarding the definition of a New Dietary Ingredient , known as NDI, that can be retroactively applied to products already on the market.

You can read the FDA Draft Guidance on New Dietary Ingredients (NDI's) here. A detailed analysis of the FDA Draft Guidance is also available.

According to Richards:

"It is important to understand that this is a Durbin effort to ruin the dietary supplement industry, using both newly proposed legislation (S.1310) and retroactively redefining the DSHEA law through new FDA regulations to reflect what is being proposed in S.1310 – undermining the clear intent of the DSHEA law.

The DSHEA law intended consumers to have wide access to dietary supplements. Durbin is intent upon the opposite." These regulations seek to change what was essentially a notification process into a costly approval process. The net effect of the regulations is to reclassify many nutritional compounds currently on the market as NDI."

The DSHEA legislation states that:

• the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
• dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare;
• and legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness

The proposed mandates directly contradict what DSHEA sought to prevent, and the FDA is using its authority in direct violation of Congressional intent. As explained in an article by Alliance for Health, the proposed regulations turn what was clearly supposed to be a pre-market notification system into a pre-approval system, just like that of drugs. As a result, dietary supplements that have been freely available for nearly two decades can be forced off the market until they receive NDI approval. And the NDI approval process is a lengthy affair that may take months or years to complete, and cost a small fortune.

What might make an "old" ingredient "new," under the new regulation?

The methods of production and extraction, for example… As bizarre as that sounds, the mere fact that a product is being extracted or produced by improved means compared to methods used in the past, could reclassify any grandfathered nutrient as an NDI that would now have to undergo the same type of safety testing and approval process as a drug.

Ridiculously Excessive Safety Testing Would be Required Under New Rules

If the FDA and Durbin get their way, once a supplement is taken off the market pending approval as an NDI, the manufacturer would have to conduct outrageously expensive studies using abnormally high doses—in some situations multiplied by a "safety factor" up to 2,000-times the recommended dosage on a per product basis. In fact, some of the safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are FAR safer than drugs!

An estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and administered, and two million more suffer serious side effects. How does the safety of supplements compare?

• In 2001, 84.6 percent of all substances implicated in fatal poisonings were pharmaceutical drugs, according to that year's American Association of Poison Control Centers (AAPCC) report. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). 
  
  ONE drug alone, the anti-asthma drug theophylline, which was responsible for 15 deaths that year, amounted to 66 percent more than all the available dietary supplements combined.
• According to CDC mortality data for 2005, prescription drugs killed more than 33,500 people that year, second only to car accidents. That same year, the American Association of Poison Control Centers reported 27 deaths that were associated with dietary supplements (one of which was reportedly due to Ephedra; the herbal supplement banned the year before for being too dangerous. In 2005, low-dose Ephedra was also subsequently banned).

Now, since dietary supplements are not patented drugs with outrageous profit margins, very few supplement makers will be able to afford the required safety studies, which could run in the millions of dollars per ingredient! Furthermore, the manufacturer is not the only one that would have to seek approval—every distributor that wants to use the NDI would have to file a separate NDI application.

Get Involved NOW!

Folks, this is not the time to doze off on the sidelines. Durbin's bill and the FDA proposed mandates for NDI's are a poorly veiled attempt to usurp your rights and health freedom. As Richards writes:

"This chess game is being played with a pathetic opening strategy based on imaginary safety problems. The gambit requires an ignorant public for its success."