Category : DSHEA Under Fire

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The Relative Safety of Natural Products

By Neil E. Levin, CCN, DANLA via www.honestnutrition.com
Mortar Pestle

1. Some have stated that the dietary supplement industry is largely “unregulated”.

My response: This is not really a fair statement considering that recent regulatory efforts – supported by that same industry – have clamped down on the industry’s freedom to operate outside the regulatory system. Drug and dietary supplement regulation are becoming more and more similar, though the safety records of the two types of products are remarkably distinct. The dietary supplement industry is now largely regulated, with more and more regulations closing the gaps. Indeed, the industry strongly supported the law to ban steroid precursors from being sold as dietary supplements, making all such products illegal drugs. And the 2006 passage of a law to require all serious adverse events to be reported to MedWatch within 3 weeks – now in effect – is an appropriate method of monitoring safety and determining problem areas needing increased monitoring or official action; though we should not confuse raw AERs with actual evidence of causes-and-effects. The implementation of the long-delayed current good manufacturing practices (cGMP) regulations (that were actually authorized by the oft-maligned DSHEA law in 1994) now requires all supplement manufacturers to be cGMP compliant over the next two years, but with the largest manufacturers required to follow that standard no later than this coming June (2008). cGMP regulations are forcing manufacturers to have quality controls on raw materials and finished goods throughout the manufacturing process, including identity and safety testing. The FDA already prohibits all adulterated products, and has in fact used its authority to act against known offenders, as noted by the agency itself.

2. There are claims that “the Institute of Medicine and the Food and Drug Administration have found that supplement health claims are largely unsupported”.

My response: The FDA clearly regulates supplement label claims and requires manufacturers to submit all label claims and maintain proper documentation. The agency apparently does not review this information unless there is a problem; meanwhile making manufacturers submit such information to it while requiring a contradictory label disclaimer that the FDA has not reviewed the claims. I guess that’s what’s called “plausible deniability”. However, the vast majority of responsible manufacturers are careful to present adequate documentation to the FDA, and the cGMP regulations require well-documented justification of all processes, including the writing of label claims. DSHEA requires preapproval of all new dietary supplement ingredients with an eye to proving safety, though manufacturers are allowed to use existing ingredients if they first submit their new label claims to the agency. All new drugs need pre-approval, as do all new supplement ingredients, but drugs are approved for specific uses (though often used for other unapproved “off label” conditions) while supplements are not allowed to make any disease claims, with very few exceptions for FDA-approved health claims. www.cfsan.fda.gov/~dms/supplmnt.html

Bias Against Natural Products

By Neil E. Levin, CCN, DANLA via www.honestnutrition.com

Supps

Once again, a widely distributed article has savagely attacked the safety and efficacy of natural products; including vitamins, minerals, and herbs. That this article may be more commentary than journalism is immediately revealed by the author inexplicably linking energy medicine (with admitted health benefits for patients) with a concocted image of “shooing evil spirits”, even when performed by technicians in a top trauma hospital. The ignorance of journalists and medical experts is exposed when they claim that natural products are intended as cures and treatments. These products are actually prohibited by law from claiming this; allowed only documented claims to support healthy body structures and functions. Ironically, this is the same law – the Dietary Supplement Health and Education Act, DSHEA – that is falsely mischaracterized as “deregulation” of the industry. In fact, this law prohibits new ingredients without FDA pre-approval; empowers the agency to regulate manufacturing, advertising, and label claims; prohibits unsafe, adulterated, and mislabeled products; and even allows banning a product based on only theoretical risks. A recent companion law requires all serious adverse events be reported to the FDA; generating far fewer reports than expected.

The erroneous assumption that dietary supplements should be considered as potential treatments or cures has resulted in many negative reports. One problem is that some medical researchers, perhaps too used to drug studies using novel substances, sometimes base reports mainly on supplementation levels but fail to properly understand or explain other relevant variables such as dietary intake and relationships to other nutrients that affect body levels and functions of the targeted nutrient. The synergies of natural substances in the diet are complex and interactive, but many researchers design simplistic studies that generate incomplete or misleading data; often leading to dramatic conclusions that the pharmaceutical advertising-dependent press eats up. A press that fails to investigate and present all of the relevant facts and perspectives in a sensational negative report may be accused of laziness, if not bias. Rigorous studies refuting negative reports about the safety of vitamin E, beta-carotene, herbs, the use of supplements with cancer treatments, and drug-nutrient interactions have been noticeably absent from the same media that eagerly broadcasts reports attacking nature’s own nourishing substances. Sadly, there is no matching eagerness to set the record straight.

Let’s keep this in perspective. We have all seen drugs pulled from the market because of unforeseen safety issues, medical schools and authors of articles published in peer-reviewed journals accused of being on the take from pharmaceutical companies, contaminated drugs as well as hundreds of thousands of deaths and millions of hospitalizations caused by pharmaceutical side effects each year. Foods cause hundreds of deaths and millions of illnesses annually. Compare this to dietary supplement safety, where proven deaths are extremely rare. Supplement users believe in the healing power of nature, at odds with the often unproven treatments of conventional medicine. The goal of Integrative Medicine is putting aside traditional institutional medical bias to allow science to dictate the comprehensive treatment of an individual patient, including quality of life issues. Many millions of Americans choose to use natural products in order to protect and improve their own health and vitality. Reasonable people will reject these sensational assaults on natural health (including dietary supplements), recognizing that conventional medicine sometimes fails without a little help from Mother Nature.

Industry Self-Regulation and FDA Ensure Dietary Supplement Safety & Quality

Safety

By James Gormley via www.thegormleyfiles.blogspot.com

If retailers ask their customers about dietary supplement safety, they’re bound to get a variety of responses, especially considering that quality and safety often go hand-in-hand.

In terms of quality, Vitamin Retailer magazine’s 2007 Annual Retailer Survey showed that the percentage of retailers who identify “high quality” as the most important element of their store’s success nearly doubled from the previous year—from 13.9 percent to 27 percent.

While a 2008 survey sponsored by the Council for Responsible Nutrition (CRN) tells us that over 80 percent of American consumers are confident that they are buying high-quality and safe dietary supplements, bad press is likely to discourage potential, fence-sitting shoppers from hopping off that fence and going into their favorite health food store, especially if yet another scientific study has just been misrepresented by researchers or misreported by media.

What does Mel Gibson have to do with DSHEA?

By James Gormley via www.thegormleyfiles.blogspot.com

A public-service ad that first aired in December 1993 showed camouflaged Federal agents equipped in full Special Forces gear, including night vision and weapons converging on Mel Gibson, who says, in defense, as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

Before DSHEA

This call-to-action video warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?”

Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?”

How DSHEA was really won

By James Gormley via www.thegormleyfiles.blogspot.com

DSHEA, the Dietary Supplement Health and Education Act of 1994, is the law which protects our access to dietary supplements and to truthful information about them; it also provides for the quality and safety of supplements.

What led to the passage of this law was a historic grassroots and political battle, a struggle that actually had its roots in the early days of the modern health-food industry.

In 1990, President George H.W. Bush signed into law the Nutrition Labeling and Education Act (NLEA). This legislation was intended to improve nutritional information regarding health claims made for products. The FDA was given the job of implementing the law, but because of its broad wording, the agency began to capitalize on the opportunity to over-regulate safe and beneficial nutritional products.

GAO Report on Supplements

We predicted late last year before, during and after the election that 2009 would begin a time of change and challenge for dietary supplements. It looks like the first shoe has dropped: The U.S. Government Accountability Office (GAO) presented a report to Congress last week, titled Dietary Supplements: FDA Should Take Further Action to Improve Oversight and Consumer Understanding.

A link to the full 70+ page report appears at the end of this article. Here are a few highlights:

Congressional Dietary Supplement Caucus Update

WASHINGTON—The Congressional Dietary Supplement Caucus, in cooperation with the two the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), hosted the third of a series of lunch briefings since the Congressional Dietary Supplement Caucus was founded. The briefings were aimed at educating Congressional staffers on important issues related to the dietary supplement industry.

William Cooper, M.D., medical director of cardiovascular surgery, Wellstar-Kennestone Hospital in Marietta, Ga., and assistant professor of Cardiothoracic Surgery, Emory University School of Medicine, spoke to more than 90 attendees about the importance of using dietary supplements as part of an overall healthy lifestyle. Dr. Cooper also offered advice for how supplements can play an important role in prevention and healthcare reform.

“When you get to me, you really don’t want to buy what I’m selling,” said Dr. Cooper, referring to his heart surgery specialty. He encouraged the individuals in the audience to focus on preventative health, rather than the current sick-care health system that is in place. “As a nation, we are consistently inconsistent. But there are simple things that all of us can do every day to better our health—and that includes taking dietary supplements.”