Sunday, February 8, 2015

FDA and Herbal Medicine - Caveat Emptor!

Many of my patients are taking herbal supplements, or so they think.  This herbal and health supplements industry likely is envied by traditional pharmaceutical companies.  The latter has to spend zillions of dollars proving safety and efficacy to the Food and Drug Administration (FDA).  Many of these drugs are cast aside during the approval process or afterwards when serious side effects become known or a new medicine is proved safer and superior.  While it’s not quite a crapshoot, there is a strong element of chance at play here.

Roll the Dice with the FDA?

Herbs and the supplements that are saturating our airwaves escape FDA scrutiny.  They will only draw governmental fire if they are deemed to be dangerous.  They are required to use certain language in their promotional materials that differs from traditional FDA approved prescription medicines.  Take a look at this example:

Fosamax:  The FDA has approved this for the treatment and prevention of osteoporosis
Glucosamine chondroitin:  Promotes bone health

Somehow the vague but promising phrase, ‘promotes bone health’ is supposed to insulate the company from a claim that it is approved to treat an actual disease.  However, for most of us, promoting bone health sounds like it’s designed to prevent osteoporosis, which is exactly the intent of the company’s marketing folks.  The language may be legally distinct from the Fosomax verbiage, but it sure sounds the same to me.

The FDA has a very light regulatory hand over dietary supplements making sure that there are no overtly misleading claims and that the product contains what the label states it is.  There is no FDA approval of efficacy as is required for prescription pharmaceuticals.

With a market worth billions of dollars, would you prefer to invest in a pharmaceutical company that might need 7 years to bring a drug to market or in a supplement manufacturer that only needs to cross over a few speed bumps before marketing potions that combat fatigue, joint pain, depression and memory lapses?

It amazes me that the public swallows millions of these pills in the absence of medical evidence of efficacy.   Who says that Americans are not a people of faith?

Recently, a New York State investigation discovered that 4 out of 5 herbal products tested contained none of the herbs listed.  The investigation examined herbal products at some little known ‘mom & pop’ pill shops including Walmart, GNC, Target and Walgreens.

If a company is peddling a placebo, can't it at least accurately label the herb?  If I'm buying a jar of snake oil to ease my rheumatism, or should I say to promote good joint health, then I expect that the useless elixir won't be lizard oil, olive oil or motor oil.  


4 comments:

Royal Bee Natural Products Pvt Ltd. said...
This comment has been removed by a blog administrator.
Barbara said...

What prevents the FDA from having approval over supplements? I have long counseled friends and family to stop self medicating. I wish the FDA would take over regulation!

Anonymous said...

The NY AG's testing was done using an inappropriate method. Plant extracts often do not contain amplifiable DNA, whereas an extremely sensitive method - such as those that might be used by a dinosaur expert with an axe to grind - can amplify DNA from inert ingredients like rice powder, minute amounts of contaminants such as exist in all products, or even a few stray cells from the houseplant in the lab window. The use of absence of DNA to claim fraud - chemical fingerprints be damned - has already been tried by a Canadian group and thoroughly stomped on. This AG has taken it a step further by (a) refusing to release details of his methods - were there even any negative controls? - and (b) using a method not fit for purpose to issue government diktats that deprive businesses of perhaps millions of dollars of income and consumers of access to products they wish.

It is a very bad idea for doctors to jump on such disastrously flawed bandwagons. When they publicly run off the rails, the pronouncement that SJW supplements are "made from House Plants!" will be filed in memory along with such gems as "No, your statin can't possibly be causing your memory impairment." Then when you want to try to convince someone, say, that they really should get their kid vaccinated for measles, they begin with the presumption that you are not a source of unbiased information.

Michael Kirsch, M.D. said...

I thank the anonymoous commenter above for his or her thoughtful response. I do not have the technical knowledge to engage you in your alleged failure of the technical process used by the AG and I am not aware of a a lack of transparency. I am not stating that you are wrong on your points, only that I am not equipped to debate them on the merits.
Do you claim that the various products that have been pulled were, in fact, pure and not contaminated or adulterated? Do you feel confident that herbal products are being manufactured at a high quality level? We are leaving aside, of course, the important issue of efficacy. As for your statement that the gov is 'depriving...consumers of what they wish, I do not think this should be our guiding standard.

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