Integrator Columnist Michael Levin on the McCain's Dietary Supplement Act; McCain Backing Down
Written by John Weeks
Integrator Columnist Michael Levin on the McCain-Dorgan Dietary Supplement Safety Act of 2010; McCain Backing Down
Summary: The "McCain bill,"as it quickly became known, has stirred up a furor in the integrative practice and natural products communities. Practitioner, consumer and industry interests are peppering their lists with alerts about a proposed bill which they argue will increase regulatory burden, limit access to supplements and significantly increase costs. US Senator John McCain used the Senator floor to take on the arguments of his opponents. Major league sports are backing McCain. The proposal is called the Dietary Supplement Safety Act of 2010. Here are links to key viewpoints followed by a critical analysis from Integrator columnist Michael Levin whose professional career spans executive positions in big Pharma and the supplements industry. He offers a useful regulatory strategy by focusing on the narrows of the production river. (Note: At publication time word arrived that McCain was backing down.)
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US Senator John McCain (R-AZ) argues that he and Bryan Dorgan (D-ND) are merely doing the bidding of major league sports organizations with their proposed Dietary
Supplement Safety Act of 2010. A supportive statement from major league baseball commissioner Bud Selig is here.
The
bill was greeted with significant opposition by industry, practitioner
and consumer organizations. These argue that the bill will drive up
costs and limit access to consumers for products that are already safer
than most drugs. Examples and links are: Council for
Responsible Nutrition (here), American Herbal Products Association (here), American Association of Naturopathic Physicians (AANP-here) and the industry-consumer Alliance for Natural Health-USA (ANH-here). The latter's electronic alert generated over 80,000 responses. Gretchen DuBeau, ANH's executive director, asserts that if "passed as written, this bill
would likely result in the
disappearance from store shelves of many supplements currently on the
market,
and unbridled authority would be handed to the FDA, an agency that needs
a top
to bottom overhaul, not ever more power over our lives."
McCain, aware of the outpouring of antagonism, responded with a statement
on the Senate floor. The debate breaks over whether the bill fundamentally shifts regulation
of supplements and will limit consumer access. McCain says no. The
industry and related groups say yes.
In this critical review, Integrator columnist Michael Levin of Health Business Strategies offers thoughtful perspectives on the proposed legislation. He is an interested and knowledgeable observer of product regulation as a past executive with both Big Pharma and with dietary supplements firms. He presently consults with various healthcare entities, including supplement firms. Levin concludes his article with a useful proposal.
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Dietary
Supplement Safety Act of 2010: A Critical Review
Michael D. Levin,
Health Business Strategies
February, 2010
Michael Levin
The Dietary Supplement Safety Act
of 2010, a bill proposed by Senators McCain and Dorgan, has been referred to
the Committee on Health, Education, Labor and Pensions. The details of this
bill and the committee members can be found here.
While the stated intent is to
“more effectively regulate dietary supplements that may pose safety risks
unknown to consumers,” this bill is an excellent example of well-intentioned
legislation failing miserably to achieve its purported goals, leaving in its
wake an expensive regulatory burden for both FDA and industry. Worse, it puts
safe and valuable dietary ingredients at risk of being removed from the market.
Key provisions include:
1) An company which “manufactures, packages, holds,
distributes, labels or licenses a dietary supplement” must register with the
FDA and submit a copy of all “labeling” for all “dietary supplements” it
handles, along with a “full list of the ingredients contained in each dietary
supplement," which must be updated each and every year.
"This bill is an excellent example of
well-intentioned
legislation failing miserably to achieve its purported goals, leaving in
its
wake an expensive regulatory burden."
2) Moreover, a “dietary supplement facility or retailer”
shall “obtain adequate written evidence from the preceding responsible entity
in the chain of commerce that the product is registered as required with FDA under
this regulation.
3) All companies registering their products with FDA must
“create and maintain a substantiation file relating to the claim that the
dietary ingredient or dietary supplement will reasonably be expected to be
safe…..the substantiation file shall be prepared and maintained in such form
and manner as the Secretary may prescribe and shall be available for review and
inspection by the Secretary upon request”.
4) New Dietary Ingredients (NDIs) as defined in DSHEA is
gone. The NDI provision allowed for continued use of dietary ingredients
provided they were in commerce prior to 10/15/94. Instead, this bill requires
that the Secretary maintain a list of all “Accepted Dietary Ingredients”. If an ingredient is not on the “Accepted
Dietary Ingredients List”, it is “adulterated” and cannot be legally sold.
5) Serious Adverse Effect Reporting requirements are
modified. The word “serious” is removed, thus requiring all companies to report
all non-serious adverse effects to the FDA “accompanied by a copy of the label
on or within the retail packaging of such dietary supplement”
"Will consumers be better protected
if 800
companies build a
substantiation
file for 500mg vitamin C tablets to be
taken twice
daily? I
think not."
6) Recall Authority: The bill provides FDA with
unprecedented sweeping recall authority in the event the product is
“misbranded”, “adulterated”, or if the Secretary finds there is a reasonable
probability that a “dietary supplement would cause serious, adverse health
consequences or death”. If such a mandatory recall is ordered by the FDA, the
responsible party has the option to notify FDA of its intent to challenge the
recall and have a hearing, which must occur within 10 days of the initial
order.
Assessment: With an announcement apparently timed to coincide with
the Olympics, this bill was applauded by stakeholders in the US Anti-Doping
Agency (USADA) and members of the Supplement Safety Now coalition.
These stakeholders rightly object to “designer steroids” – illegal substances –
that render an athlete illegally “supercharged”, and the supplement illegally
“adulterated”.
Is this bill likely to eliminate
“designer steroids”? Not at all. Such adulteration is already illegal.
What might this bill cost? Let’s review:
1) Using conservative estimates, if the 1400 or so
supplement companies each have an average of 30 products on the market, FDA
will receive 1400 annual reports involving 42,000 products. Does FDA have the resources
to build, review and maintain this database and prosecute non-compliance?
2) If each company uses an average of 100 unique dietary
ingredients, the substantiation file requirements could be enormous. Looking at
it from another perspective, if the average product has 3 ingredients, we would
have 1400 companies building 126,000 substantiation records. Worse, in having
each company responsible for their own substantiation records, and with many
similar products being marketed by multiple companies, the redundancy would be
staggering. Will consumers be better protected if 800 companies build a
substantiation file for 500mg vitamin C tablets to be taken twice daily? I
think not.
"This unprecedented recall authority,
combined
with a 'positive list of
approved ingredients' is viewed as
extremely
worrisome for
obvious reasons,
especially by conspiracy theorists."
3) The real mystery questions are: What form of
substantiation will satisfy the Secretary? And, how will the Secretary decide
which dietary ingredients to add to the “Accepted Dietary Ingredients”
list? What happens to the ingredients
that are overlooked? Under the bill, the Secretary would have
the authority to issue a mandatory recall because the product is, technically,
adulterated (i.e., the supplement contains an ingredient not on the Accepted
Dietary Ingredients list). This unprecedented recall authority, combined with a
“positive list of approved ingredients” is viewed as extremely worrisome for
obvious reasons, especially by conspiracy theorists.
About Adverse Events, Serious and Otherwise: Of course, the
mandatory reporting of all adverse events (not only serious adverse events, as
now required under law), puts even more burden on FDA with no reasonably
foreseeable upside for the public health. How much burden? If 1400 companies
receive only 30 complaints of adverse effects/year, FDA would have to record
(and presumably review) an additional 42,000 complaints annually (still a
fraction of what they read from Pharma).
While immediate reporting of serious
adverse events, as required under law, is both appropriate and necessary
for protecting the public health, the reporting of clearly frivolous complaints
associated with non-labeled use of a dietary supplement (eg, “my dog ate a
bottle of your product and vomited”) is as much a waste of time as if food
companies were required to report all adverse events. Food companies are not
required to report all adverse events. If they were, the FDA would be pouring
over complaints about little Johnny eating a gallon of ice cream and getting a
tummy ache. I consider neither example a wise use of taxpayer dollars. Adverse Events: The Bottom Line: FDA review of all adverse
reactions associated with the use of drugs is appropriate and an essential
part of post-marketing surveillance for all products intended to treat disease.
FDA review of all adverse reactions associated with foods and dietary
supplements – products intended to provide nutritional support - is inappropriate. FDA review of all serious
adverse reactions (defined below) associated with dietary supplements is
currently required under current law and, from a public health and safety
perspective, totally appropriate.
Serious Adverse Event – Current Legal Definition Results in death, a life-threatening experience,
inpatient hospitalization, a persistent or significant disability or
incapacity, or a congenital anomaly or birth defect; or
Requires, based on a reasonable medical judgment, a
medical or surgical intervention to prevent an outcome described above.
"I support [the FDA]
vigorously prosecuting
those found guilty of conspiracy to violate
federal food
drug and cosmetic laws by endangering
the public health with illegal
products."
The View From Here: We unfortunately live in an age of anxiety and mistrust.
The sad fact is this: every industry has a Bernie Madoff. In the supplement industry, these a few
“bad actors” who, in their greed, selfishness and disregard for the public, have
not let their quest for cash be deterred by regulations. Instead of promulgating burdensome regulations that will do
nothing meaningful to prevent adulteration, I support arming the FDA with the
resources necessary to enforce existing regulations. I support their
vigorously prosecuting those found guilty of conspiracy to violate federal food
drug and cosmetic laws by endangering the public health with illegal products (be
they foods, supplements or drugs). Sending a few to jail after seizing their
assets and forever prohibiting them from ever returning to their industry just
might serve to deter others from following their “yellow brick road”. If
there’s a brick wall at the end of the brick road, others just might choose
another path. Given the current state of enforcement where egregious offenses
often only result in monetary fines, there is not a brick wall, only a toll
booth. The most recent “toll booth” example can be viewed here.
Levin's Recommendation
Levin proposes legislation which goes to the source - requiring the laboratories that would first discover adulterants to immediately report them.
Alternatives?
And if we cannot rely upon enforcement of current regulations to protect the
public health and feel compelled to commit taxpayer dollars to new regulation,
logic suggests that we take a cue from US Customs. How? Protecting our food
supply by detection of adulterants at the point of entry is, arguably, the
logical place to start. Where are dangerous adulterants first detected? They
are first detected at analytical laboratories who test raw materials and
finished products. The lab: customer relationships are protected under client
confidentiality agreements. Might it make sense to legislate a requirement for
laboratories to immediately report to FDA the confirmed presence of dangerous
economic adulterants in foods, dietary ingredients and dietary supplements?
Taking that step seems a more logical approach towards
protecting the food supply and the public health.
Conclusion:
Let’s let FDA enforce the current regulations, let them focus their limited
resources on pursuing Big Issues (e.g, the GSK/Avandia increased heart attack
risk issue)
and, with this legislative alternative, have a new early warning tool by which
to protect the food supply.
Meanwhile, S 3002 should be defeated quickly. To make your
voice heard, please click here.
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Comment: Years ago I came across the obvious and still metaphorically useful war strategy from ancient times that consisted of controlling the narrows of a river. The victor regulates trade going both ways. Levin's recommendation, to focus on the laboratories, is such a narrows. Will his idea gain traction? Has it been suggested before? Levin notes some industry interest in this direction.
Meantime, members of Congress will face another ancient wartime strategy called "overrun the enemy" if they press ahead with the McCain approach. Supplement consumers like our products. Users are quickly riled to action as the
ANH-USA alert showed. While my own bias is that there are perhaps more
"bad actors" than Levin believes, McCain is certainly trumping up risk
to push his case. Readers of history will recall the adage that just because I'm feeling paranoid doesn't mean they are not out to get me. This proposal would certainly make the products more expensive and thus alter their accessibility.
The good news for supplement consumers is that the McCain-Dorgan bill landed in the US Senate HELP committee, chaired by US Senator Tom Harkin, and on which US Senator Barbara Mikulski serves. Both have been significant supporters of integrative practices. Those opposing the bill will get an audience.