The Santa Cruz Sentinel
Tuesday 17 April 2007
The federal Food and Drug Administration is proposing to regulate a wide variety of alternative medicine products, from vitamin, mineral and herbal supplements to lotions and stones used by massage therapists.
The April 30 deadline for public comment has stirred up a storm of protest on the Web since Mike Adams, the self-proclaimed "Health Ranger" from Tucson, posted an alert April 11 at www.newstarget.com. The Organic Consumers Association, based in Minnesota, picked it up, followed by the Daily Kos and the Free New York Blog.
"This could be potentially devastating, not just to my business but to any business relating to supplements," said Sophy Winnick, a Felton mother of four who has been selling Youngevity products for 10 years. "People better get on the horn about this"
Dr. Marcus Kwan, executive director of the Santa Cruz County Medical Society, saw the FDA's move differently.
"It probably is a good thing for them to start getting involved," he said. "Almost all patients are taking something [that is non-prescription] with active components. I'd rather see [the FDA] do something than nothing at all"
The proposal appeared in a Dec. 6 document described by the FDA as "draft guidance"
Asked what prompted the action, regional FDA spokeswoman Jeanette McDonald pointed to the Federal Register, which published a notice of the proposed FDA regulation Feb. 27. As more people turn to alternative medicine, there is "increased confusion" as to whether products used by practitioners are subject to regulation, the FDA notice said.
According to the FDA, more than a third of American adults report using some form of "complementary and alternative medicine," which includes biological products, massage therapy and energy medicine. Visits to those providers on an annual basis exceed those to primary care physicians, according to the FDA.
Nutritional supplement sales are believed to be a $5 billion industry in America.
Health alternatives are very popular in Santa Cruz County, home to supplement manufacturers Nordic Naturals, Aloha Medicinals and Threshold Enterprises. The county also is home to schools like Twin Lakes College of the Healing Arts and Cypress Health Institute, which offer training in massage, and natural food stores like Staff of Life and New Leaf Community Markets, which sell an array of botanical products as dietary supplements.
Dario Dickinson, co-owner of the Herb Room/Food Bin in Santa Cruz, said the proposed regulation took him by surprise.
"What in the world is this?" he asked himself. "There's huge political movement against it"
Opponents have more confidence that free markets will do a better job of protecting consumers than government bureaucracy.
Santa Cruz physician Maria Greaves said she has concerns about some products, citing the example of "red yeast rice," a herb with the same active ingredient to lower cholesterol as the drug lovastatin.
"Because they act by the same mechanism, they have the same potential toxicities," she said. "Unfortunately, patients aren't advised that they need to do routine blood tests to monitor their liver when they start an herbal remedy like this on their own"
Greaves said purity and concentration of the desired component in herbal supplements vary, sometimes significantly, even within the brand.
"That is a huge issue when it comes to prescription and herbal drug interactions," she said. "It is difficult to know exactly what people are taking when they take vitamins and herbs. For the safety of the consumer, there needs to be some standardization and review process"
Suzy Hunt, a Scotts Valley massage practitioner, suspects "a Western medical/insurance lobby in the background somewhere"
After being hospitalized for more than five weeks, she said she asked doctors about supplements and therapies to aid her recovery and came up empty. The treatments she felt helped, including massage, herbal skin cream and acupuncture, she found on her own.
"I suspect that if we look at the data, more and more people are preferring 'alternative" healing therapies, which include vitamins and supplements, even if their insurance doesn't cover these," she said. "Why? Because they are about preventing illness"
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