Hold onto your goji berries and massage oils, people. The U.S. Food
andDrug Administration (FDA) may be coming for them, if alarmist emails
making the rounds throughout the local alternative health community is
correct.
“When it comes to health freedom, this is the FDA’s end game,”
read an Apr. 19 email from Richard Diehl to the local alternative
health community. “This is not a thing to ignore.”
Diehl’s message is hardly alone in cyberspace. All over the nation
massage therapists, health food store owners and just about everyone
else who considers him or herself part of the alternative health
industry is concerned over the FDA’s recent “Draft Guidance,” which
deals with “Complementary and Alternative Medicine Products and Their
Regulation.” Public comment on the document, which began on Feb. 27,
ends on Apr. 30.
It’s not surprising that alternative health counselors and
practitioners see trouble if the FDA moves to increase its oversight of
their industry.
“It’s just their way to hamper competition,” said Sheea Shafer, who
founded the Holistic Association of Hawai`i, which promotes what she
calls “a health and wellness lifestyle.” (Shafer also forwarded Diehl’s
original email to Maui Time.)
“On Maui, this is a way of life for many of us,” Shafer said. She
added that new regulations “would be a huge act of control that would
end up being a farce.”
Ironically, the FDA insists the Draft Guidance has nothing to do with regulating the industry.
“The Draft Guidance is not a regulation,” FDA spokesman S. Mitchell Weitzman said. “And it’s not a prelude to regulation.”
What it is, Weitzman said, is an attempt by the FDA to clear up some
“confusion” over which alternative health therapies, products and
practices fall under current FDA regulatory laws. According to
statistics cited in the Draft Guidance, “more than one-third” of
American adults today are using some sort of alternative health
practice or product. In fact, visits to alternative health
practitioners “each year exceed those to primary care physicians.”
“There are hundreds of products out there,” Weitzman said. “If
[people] have a question about a specific product, we invite them to
call us. That’s what we’re encouraging people to do.”
Indeed, the Draft Guidance says its purpose is to “represent the
agency’s current thinking” on what it calls “complementary and
alternative medicine [CAM].” The document defines CAM as “a group of
diverse medical and health care systems, practices, and products that
are not presently considered to be part of conventional medicine.”
As the Draft Guidance shows, there aren’t many specifics concerning
the FDA’s relationship to alternative health. For instance, “botanical
products” like vitamins, amino acids, proteins and animal-derived
extracts “may be regulated as drugs, cosmetics, dietary supplements, or foods” (emphasis added).
By contrast, the FDA already regulates biofeedback machines (as well
as acupuncture needles), but the Draft Guidance says “mind-body
medicine” like hypnosis, yoga, meditation, tai chi, qi gong and group
support “would not be subject to our jurisdiction” (emphasis in the
original). Similarly, the FDA does not believe chiropractic
manipulation, massage therapy and reflexology fall under its regulatory
guidelines, though massage lotions and oils “may be subject to
regulation.”
What all this means for the industry is hard to say, though Weitzman denies that it will change much.
“Don’t expect anything surprising,” he said when the comment period
ends and the final guidance emerges. “I don’t think there’s any
intention that this will lead to new regulation. We just want to
clarify questions people have raised.”
As far as Shafer is concerned, the FDA would be foolish if they start issuing new regulations.
“People are really waking up and using alternatives,” she said. “I
just think this is kind of a joke. If they accomplished it we would be
in a bad state.”
For more information on the FDA’s Draft Guidance, visit
www.fda.gov/cber/gdlns/altmed.htm. MTW