On August 23rd, Newsday, a New York City newspaper ranked by Dr. Tim Groseclose as
one of the top 61 most “liberal” local newspapers in the U.S. ran an article amazingly
entitled, “FDA Official: 70% of Supplement Companies Violate Agency Rules.”
By “liberal” Groseclose did not mean the classical liberalism of a Thomas
Jefferson or an Abraham Lincoln but the “big government,” nanny-state modern liberalism ushered in by Woodrow
Wilson and expanded upon after 1921.
So perhaps we should not be completely surprised that any
liberal paper would slant its coverage to support the unaccountable
bureaucratic leviathan than the FDA is today ─ but, sadly, this does not serve the
paper’s roughly 378,000 daily readers, readers who are, in large part, also consumers
of dietary supplements ─ or at least they were
before the above-cited “the sky is falling” article.
Dietary Supplements: The Real Story
Good Manufacturing Practices (GMPs) for dietary supplements
are not new. The federal Current Good Manufacturing Practices for dietary
supplements (21 CFR Part 111) were issued six years ago, and the Natural
Products Association (NPA) rolled out its own voluntary GMP-certification
program in 1999.
Contrary to the horror show of allegedly widespread incompetence,
contamination and criminal negligence portrayed by the article, dietary
supplements (a class of food products) are even more regulated than is food. According
to whom, you ask?
How about the country’s most respected expert on food and
drug law, attorney Peter Barton Hutt, who served as Chief Counsel for the FDA
from 1971 to 1975, has taught food and drug law at Harvard for over 20 years, is
the co-author of Food and Drug Law: Cases
and Materials (Foundation Press, 3rd edition 2007), and has
published more than 175 book chapters and articles on food and drug law and also
on health policy?
“The [Food Drug and Cosmetic Act], as amended by DSHEA and
the Dietary Supplement and Nonprescription Drug Consumer Protection Act,
provides somewhat greater FDA regulatory authority over dietary supplements
than over conventional food,” noted Hutt in a white paper commissioned by the
Council for Responsible Nutrition (CRN) entitled FDA Statutory Authority to Regulate the Safety of Dietary Supplements
(2nd edition, 2011).
Safety: The Facts
According to the Newsday
article, approximately 6,300 adverse event reports were submitted for
dietary supplements from 2008 to 2012, a 4-year period.
Not even considering
the fact that most of these reports were likely inaccurately linked to supplements
when other factors were the more probable causes, in the same period Pharmaceutical Commerce reports that
were approximately 3,260,000 adverse events reported for pharmaceutical drugs!
I don’t recall seeing this stark comparison in the newspaper
article.
The FDA official quoted in the story, Daniel Fabricant,
Ph.D., was formerly the science head for the NPA, and was a staunch defender of
natural products until he became its chief critic at the FDA.
On August 26th, John Spilateri Shaw, the CEO of Dr.
Fabricant’s alma mater, the NPA, noted in an open letter to Newsday that “industry members strongly
support providing additional resources for the FDA to keep illegal products
disguised as legitimate supplements off the market.”
The vast majority of “supplements are beneficial, and
millions of Americans depend on them each day,” Shaw added in his letter. “Your
readers should continue to use these products that safely and positively
influence their lives on a daily basis.”
Prescription and OTC Drugs: Safety? Not So Much
And what about the FDA takeover of three drug plants in 2011
following “shocking conditions” at the plants where one of the most popular
line of over-the-counter (OTC) pain relievers (rhymes with “i-lenol”) were manufactured.
"This inspection report is pretty close to being the worst I've seen,” according
to David Lebo, a professor of pharmaceutical manufacturing at Temple University
in Philadelphia, in an interview for CNNMoney.
The inspections reportedly uncovered safety and quality
violations in every system, control and process, from bacterial contamination,
to filthy manufacturing and storage conditions, to super-potent levels of pain
relievers in batches of the infant pain-relief formula.
Didn’t see much media coverage of this, did you? I only
noticed an obvious absence of the products from store shelves, and that was my
first tip-off.
Hutt added: “DSHEA provides greater FDA scrutiny of new
dietary ingredients than exists for new conventional food ingredients and adds
new safety enforcement authority for all dietary supplements that extends
beyond the FDA authority applicable to conventional food.”
Adulterated Supplements Are Illegal Drugs, Not Supplements
As to cases of deliberate
adulteration of dietary supplements, if the ingredients were anabolic steroids,
the product in question would then be an illegal drug ─ not a supplement ─ and
it is subject to action by the U.S. Drug Enforcement Administration (DEA). I have been calling for the DEA to step up to the plate since 2010.
The same with deliberate contamination with weight-loss,
sleep aid, or sexual health drugs, the rare number of cases of this type of
adulteration also renders this type of hybrid product an illegal drug; it is no longer a
dietary supplement product or issue.
As to even more rare cases of legitimate manufacturers who
unwittingly receive and use shoddy, contaminated or adulterated raw materials
due to falsified documentation and certifications, it is the manufacturer’s
responsibility to ensure the purity and safety of the ingredients it uses, and
there are multiple mechanisms in place to quarantine, test and verify
ingredients before they are included in finished dietary supplement products.
Peter Barton Hutt's Takeaway on Supplement (Hyper) Regulation
“DSHEA adds three additional procedural safeguards for
dietary supplement court actions to assure that FDA will act fairly and
equitably in its enforcement of safety requirements, but does not substantially
change the requirements applicable to court actions involving conventional food,”
noted Hutt.
According to him, “The Dietary Supplement and
Nonprescription Drug Consumer Protection Act expands FDA’s regulatory authority
over dietary supplements by adding postmarket reporting and recordkeeping
requirements that are more stringent than those that apply to conventional
food.”
“Thus, in many ways, the current food safety provisions of the
[Food Drug and Cosmetic Act] provide FDA with greater substantive authority
over dietary supplements than they provide for conventional food, and the
modest procedural changes in the court enforcement requirements have had no
impact thus far and are unlikely to have a significant impact in the future,”
Hutt concluded.
To counter the article’s misleading timeline with one that
more accurately reflects the safety and consumer protections surrounding
dietary supplements, I offer, by way of conclusion, this one adapted from Peter Hutt's white paper:
- 1994: Congress enacted the Dietary Supplement Health and Education Act (DSHEA) to to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary ingredients.
- 2002: Congress enacted the Public Health Security and Bioterrorism Preparedness and Response to provide additional authority to assure the safety of the food supply. In 2006, Congress enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act to require mandatory adverse event reporting systems for dietary supplements.
- 2007: Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) to prohibit the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.
- 2011: Congress enacted the FDA Food Safety Modernization Act (FSMA) to improve FDA’s capacity to prevent, detect, and respond to food safety problems.
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