Sunday, August 21, 2011

FDA Escalates War on Nutritional Supplements

If you start the day like millions of other Americans with a multi-vitamin or other supplement for nutritional support to improve your health or treat a chronic ailment or perhaps overcome a diet deficiency, be aware that Big Pharma is on the move again through its bureaucratic ally, the Food and Drug Administration.

Long a captive of the industry it is supposed to regulate, the FDA is once again targeting the vitamin and supplement industry under the guise of ‘protecting the public health and safety.’  On July 1st, the FDA issued new draft New Dietary Ingredient (NDI) guidelines that has stirred the natural health community and those who cherish freedom of health choice to action

With passage of the Food Safety Modernization Act in January, the FDA has mandated that each supplement company must ‘notify’ the agency of any New Dietary Ingredient (NDI) added to its products since 1994.  Adopting a vastly broader interpretation than Congress intended, the FDA has chosen to shift notification into a lengthy and prohibitively expensive re-approval process of nutritional supplements already approved and on the market for sale.  That notification process would require extensive documentation including peer-review articles and clinical test results for every ingredient in every product with an explanation of how each Ingredient is  ‘reasonably expected to be safe.’  Such requirement is expected to involve hundreds of thousands of products that will place a huge unwieldy burden on every nutritional supplement company as well as the Agency.  Once NDI documentation has been filed, that product is required to be withdrawn from the market within two months for a ‘reassessment’ and if not withdrawn, will be confiscated as an ‘adulterated’ product.

In an additional outrageous abuse of power, the FDA has expanded the NDI guidelines to require pre-1994 dietary supplements to go through the same extensive re-approval process. The agency, well known for its antagonism to organic foods and the self-help health movement, has refused to provide a list of those Ingredients approved by the FDA prior to 1994 and is requiring nutritional manufacturers to compile and provide the pre-1994 list which must include any changes, no matter how irrelevant such as any change to ‘milligrams per serving’.  

Critics of the proposed rule fear that FDA’s goal is to create burdensome requirements with huge fees, unreasonable administrative demands and impossible-to-meet standards that will threaten the survival of smaller, less politically connected  supplement manufacturers.  Once vulnerable, the  highly organized Big Pharma will be in a position to ‘buy out’ struggling companies, creating a monopoly in total control of alternative health products that have successfully challenged the mega-national drug cartels for its market share – all long term goals of the pharmaceutical industry.

In 1994, the Dietary Supplement Health and Education Act classified nutritional supplements as ‘food’ because of their natural, plant-based ingredients (that cannot be patented) and were exempted from the same approval process required of pharmaceutical drugs   Today, that exemption is being challenged by the proposed NDI guidelines.  Many of the herbal-based nutrients and natural minerals in supplements have been part of the human diet since the first homo habilis picked berries and have been used as folk remedies for centuries.  Unlike the deleterious side-effects of many synthetic drugs, natural vitamins are far safer than man-made chemically formulated medications and pose no threat to human life.   The nutritional supplement industry has an exemplar record for safety, especially when compared with the FDA-regulated drugs such as thalidomide, Avandia, Risperdal or prozac. 

In what is probably not a coincidence of timing, Sen. Dick Durbin (D-Ill) has simultaneously introduced the Dietary Supplement Labeling Act of 2011 (S. 1310) which would require the FDA to compile a list of nutritional ingredients that could lead to adverse effects or could be deemed risky.  In addition, Durbin’s bill would limit vitamin doses based on a non-specific set of arbitrary standards.  Once an ingredient is on the list, there is no clear process to challenge the ‘unsafe’ determination, even if new evidence comes to light.

Neither the Durbin bill nor the proposed NDI guidelines accomplish anything new in safeguarding public health and safety as current laws such as DSHEA, the Nutrition Labeling and Education Act, Good Mgmt Practices standards, and the Fair Packaging and Labeling Act have all ensured the purity and quality of nutritional products.

If adopted, the Dietary Supplement Labeling Act and NDI guidance will threaten Big Pharma’s natural health competitors and create opportunities for the FDA to more easily deny the public unfettered access to  new supplement innovations as it would decrease or totally eliminate current supplements on the market as well as dramatically increase prices.

Known for armed raids on food coops and the offices of alternative health practitioners, the FDA has never made a secret of its antagonism to an alternative health movement as it has corporatized science in the name of fraudulent clinical studies. Like many Federal departments and agencies with a revolving door that swings both ways, the FDA is rife with corruption because of its cozy relationship with drug companies whose livelihood depends on the agency’s approval process.  The relationship between the FDA and Big Pharma is a worst-case yet too common example of the influence of corporate money on public policy.

With a history of putting profit before the patient, the pharmaceutical industry, the Godzilla of American business,  has a reprehensible record of fraud, false documentation on clinical tests, kickbacks and payola to doctors, improper promotional practices, illegal off-label marketing (unapproved uses) that have cost them a mere $5 billion in fines – an insignificant amount for an industry that has been known to profit $180 billion from just 12 blockbuster drugs in one year.

According to the Center for Responsive Politics, pharmaceutical companies will ‘fare better now that Obama’s initial plan to institute a public health insurance plan did not become part of the health care reform legislation signed into law in 2010”.   FDA bureaucrats get away with their own interpretation of legislation to suit their corporate suitors because the majority of Congress are in the same Big Pharma  pocket.   With an industry-wide contribution of $3 billion in the 2012 election cycle, the pharmaceuticals have, to date, donated $1.5 million to Republicans and $12.2 million to Democrats for the upcoming election.

Behind the scenes, as many as 20 once best selling drugs have lost their patent protection and will be sold across the counter as ‘generic’ products, some at significantly lesser cost to patients, the pharmaceutical giants are feeling the pinch as they see a takeover of the lucrative dietary supplement companies an easy source of quick profit.

For more information, contact the Alliance for Natural Health  

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