Should Supplements be Regulated?

Dear Future Centenarian,

A few weeks ago, I got this email from a close friend:

“Herbal meds pulled from Walmart, Target, GNC, and Walgreens after government testing shows that 79% of samples tested have NONE, that is, ZERO, of the herb you are paying for - - Stuff like St. John's Wort and Ginko Biloba, etc.

“More "evidence" that government regulation is totally unnecessary since the "free market" will regulate itself - like when Lake Erie used to catch fire and burn...  Yeah, right!  Corporations ARE people, and they're your friends (ala Mitt Romney).”

Besides not knowing what he means  by “your friends” (an erroneous assumption), I was shocked to see that he took the article he read at face value.

There are two sides to each coin, but in spite of this intelligent, PhD with a biotech and strong business background spanning approx. 40 years, he made another assumption. He assumed the article was an accurate representation of the facts.

Maybe it was… and maybe it wasn’t.

So I checked articles from Forbes and the New York Times covering the same report. I also pulled up an article from Mercola.com.

Here are some excerpts from the articles I found:

“The test used to deem the herbal products adulterated is considered inadequate and unproven by experts, such that the results cannot be considered valid.”

“The products were tested up to five times each using a DNA barcoding technique, which is at the heart of the controversy over the results.”

“The AG's office has not released full study protocols or reports of analytical data. As Forbes reported:

"[American Botanical Council chief science officer, Stefan Gafner, PhD],who also serves as technical director for the ABC-AHPA-NCNPR Botanical Adulterants Program, expressed surprise that the AG would issue such aggressive actions against major U.S. companies with just one round of research results from one investigator's laboratory.

“More detailed and published investigations by other researchers particularly with ginkgo products, seem to diverge from the results with the chain store product brands in New York.

“…the high percentage of supplements that did not contain the material indicated on the label definitely should make the investigators wonder just how accurate this approach is.'"

“The AG's investigation used DNA testing, which, according to The American Herbal Products Association (AHPA), is an "inadequate and unproven analytical method to test herbal supplement products."

“… many herbal supplements contain herbal extracts, which have a loss or denaturation of DNA material during processing. The DNA barcoding test cannot, therefore, identify the ingredients accurately. AHPA President Michael McGuffin said:

"It appears that many, if not all, of the products the New York State Attorney General tested contained herbal extracts and this processing would likely disrupt or destroy the DNA…

“If an herbal product manufacturer used this analysis, without any additional confirmation, to prove that an herbal extract is accurately identified, the U.S. Food and Drug Administration (FDA) would almost certainly dismiss this as inadequate to verify identity."

“In fact, in 2013, the New York Times reported on a similar study using DNA barcoding, which also found a sizable number of products tested did not include the product on the label. At that time, the FDA publically called the testing method invalid.
“…it appears the New York Attorney General launched an investigation patterned after the one in 2013, even though the FDA already called the data invalid.”

“… the United Natural Products Alliance is collecting "large quantities" of the supplements cited in the Attorney General's investigation and submitting them to certified botanical testing labs for analysis.”

According to ABC News:

"'They will perform universally accepted methods and procedures to test the products and will independently report their findings, which will be made public,' said Loren Israelsen, the group's president. 'We feel the most appropriate response to bad science is good science.'"

“…In performing its tests, GNC used only validated, widely used and generally accepted testing methodologies approved by standard setting bodies, including the United States Pharmacopeia, Association of Agricultural Chemists, British Pharmacopeia and European Pharmacopeia.”
“The re-test results were even reviewed by Robert Fish, who is described as an expert on FDA good manufacturing. He, too, confirmed their authenticity, stating:

“…the products at issue were each manufactured in compliance with federal FDA requirements… the products contain the ingredients stated on the labels at the levels indicated on the labels… the products are not contaminated, and… the products are therefore not adulterated.”

So do you think supplements should be regulated or not?

Well guess what? They already are.

“…very first sentence on the Food and Drug Administration's (FDA) website to settle that dispute. There, it plainly states:

"FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering 'conventional' foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

And…

“An estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and administered, and two million more suffer serious side effects. How does the safety of supplements compare?

  • In 2001, 84.6 percent of all substances implicated in fatal poisonings were pharmaceutical drugs, according to that year's American Association of Poison Control Centers (AAPCC) report. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). ONE drug alone, the anti-asthma drug theophylline, which was responsible for 15 deaths that year, amounted to 66 percent more than all the available dietary supplements combined.

 

  • In 2011, it was reported that there are more than 487 times more adverse event reports for FDA-approved prescription drugs than there are for supplements, and 409 times more serious events for drugs than supplements.”

So which of the articles are most accurate?

I have my own opinion, but it’s only that. The take home lesson here is…

… Question everything

Do I ever jump to conclusions when I read or hear sensational news? Sure. I’m not immune. Especially when the news reinforces my preconceived notions.

But learn to be a skeptic… whether or not what you read, see or hear conforms with, or violates your most cherished beliefs.

More Life,
David Kekich
____________________________

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