Proposed bills endanger supplement industry

Some industry observers have said that dietary supplements became collateral damage in a messy fight to allow drugs to influence pro baseball.

by Mary Budinger — 

A cloud of concern hangs over the supplement industry. In February, Senators John McCain (R-AZ), and Byron Dorgan (D-ND), introduced the “Dietary Supplement Safety Act of 2010.” Known as S. 3002, it would have put the natural supplement industry under control of the Food and Drug Administration (FDA). About 30 days later in a bit of legislative jiujitsu, Senator McCain withdrew his support for the bill and sought instead to modify S. 510, the FDA Food Safety Modernization Bill.

Sen. McCain said he is motivated by steroid use in Major League Baseball. Several unethical companies illegally sold steroid drugs as “dietary supplements.” Some industry observers have said that dietary supplements became collateral damage in a messy fight to allow drugs to influence pro baseball. Even at the high school level, boys report being pressured from coaches to be bigger and stronger. Some see performance-enhancing drugs as just another advance in the technology of the game.

But S. 3002 went far beyond addressing the issue of illegal drugs camouflaged as dietary supplements. It would have gutted the Dietary Supplement Health and Education Act of 1994 (DSHEA). The Act was a hard-fought, landmark piece of legislation establishing that supplements are like food, not like drugs and, therefore, are not to be regulated by the FDA as drugs. S. 3002 would have made it far easier for pharmaceutical companies to file use patents on what are now inexpensive dietary supplements and convert them into higher priced drugs. S. 3002 is still alive, although it appears stalled.

In a letter to Sen. Tom Harkin, chair of the Senate Health, Education, Labor and Pensions Committee, Sen. McCain announced that they had reached “common ground” on key provisions to be incorporated into S. 510, the food “safety” bill. These provisions include:

• Requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services
• Ensuring that the FDA has the authority to issue a mandatory recall order if a dietary supplement is adulterated or misbranded, or “the use of such supplement could cause serious adverse health consequences such as death”
• Requiring the FDA commissioner to publish guidelines on new dietary ingredients “as soon as possible”
• Mandating that the FDA notify the Drug Enforcement Administration when a new dietary pre-market notification is rejected because the product contains a synthetic anabolic steroid

The devil is in the details, as they say; exactly how will these concepts be worded in S. 510? Will small supplement companies be required to pay hefty compliance and registration fees? Will every health food store have to carry these registrations like a pharmacy? What exactly is meant by “FDA guidelines?” Is one of the silent aims of S. 510 to surrender control of natural supplements to Codex? “Codex [Codex Alimentarius, which is Latin for ‘food code’ or ‘food book,’ is a collection of internationally recognized standards, codes of practice, and guidelines] has no jurisdiction over the regulation of the manufacture and sale of supplements in the United States,” Senator Harkin stated. Yet groups like the Natural Solutions Foundation still say otherwise.

Undermining confidence in any FDA oversight of supplements is the agency’s cozy relationship with the pharmaceutical industry. According to the most recent information collected by the U.S. National Poison Data System, there was not one death from a dietary supplement in 2008. Contrast that, for example, with recent headlines about the FDA-approved diabetes drug, Avandia, which was linked to 304 deaths during the third quarter of 2009. The FDA’s numbers show that Avandia caused 83,000 heart attacks between 1999 and 2007. Yet, the FDA continues to allow this prescription drug to be sold.

S. 510 is a bill to amend the Federal Food, Drug and Cosmetic Act with respect to the safety of the food supply. Our food safety system is broken — think back to headlines of hamburger and spinach recalls and melamine from China — but organic farmers do not believe this is the way to fix it.

If S. 510 passes, an appointed “Administrator” would enforce regulations requiring farmers to use “best practices” in agriculture. Those will be defined by the Administrator — whom many expect will be Michael Taylor, Monsanto VP and the man who deregulated GMOs and is associated with getting rBGH into the food supply. By being in a position to set the definition of “best practices,” the Administrator can impose pesticides, antibiotics, hormones, irradiation of food, chemical washes, genetically modified foods, and other products and processes in the name of food safety. Those products and processes are the lifeblood of multinational corporations such as Monsanto, Cargill, Tyson and the pharmaceutical industry.

Many say S. 510 will push the smaller organic farmers out of business because its one-size-fits-all standards are designed for large-scale operations and require extensive record-keeping mandates and high fees. Organic farms are already controlling pathogens and improving food safety in various ways that conventional, industrial-scale farms do not.

“Big Ag and Big Food have distributed melamine-contaminated milk from China and salmonella-contaminated peppers from Mexico,” said Sally Fallon Morell, president of the Weston A. Price Foundation. “Yet Congress hasn’t gotten the message that they need to solve the real problems — the centralized food distribution system and imported foods — and not regulate our local food sources out of business. The major food-borne illness outbreaks and recalls have all been caused by the large, industrial food system.”

This bill fails to recognize that more and more people want locally grown produce and animal foods raised on humanely run farms. Those goals are the opposite of what big agriculture typically provides.

Mary Budinger is an Emmy award-winning journalist who writes about Complementary and Alternative Medicine. 602-494-1999.

Reprinted from AzNetNews, Volume 29, Number 2, Apr/May 2010.