Action: Please input your zip code to send an email via NHF’s FDA Supplements Campaign:
Background: The 50% of Americans using dietary
supplements will not be pleased to learn that Congress and the U.S. Food
and Drug Administration (FDA) are colluding to threaten consumer access
to cherished health care – and during a pandemic when supplements rise
in importance to save lives. Will you please oppose the unconscionable
legislative or regulatory proposals for the FDA to place dietary
supplements on a list for market elimination?
THIS MATTER IS VERY URGENT, because the FDA
has stated it will finalize next year its draft Guidance on New Dietary
Ingredients (NDIs), first proposed in 2011, which would subject more
than 30,000 “new” supplements to harsh and unnecessary drug-like
regulations to prove their safety. We already know that supplements are
about the safest consumer product someone can ingest, safer even than
food. Why drive their cost up just to satisfy unnecessary and costly
regulations? Many supplements will even be driven out of the market
because they will not be worth the time and money to “prove” to the
FDA’s satisfaction that they are safe.
The approval requirements would apply to all supplements
brought to market after the passage date of the 1994 Dietary Supplement
Health and Education Act (DSHEA). And no thanks to U.S. Senator Dick
Durbin (D-IL), Congress may exploit the appropriations process to insert
into “must-pass” legislation language mandating a list enabling FDA to
target what they label as “New Dietary Ingredients” (NDI) - that is,
supplements created after the 1994 Act.[1]
The FDA proposed its 2011 guidance in a way so violative of
the 1994 Act that it garnered a landslide of comments that buried the
guidance for a half a decade. The Senate even allowed a related bill to
have a vote, but it was defeated soundly. Not content to respect
consumer preference for natural health, powerful pharmaceutical
interests goaded Congress in a recent Appropriations bill to support
FDA’s attack on supplements, based on a misleading 2015 U.S. Department
of Health and Human Services study showing 20,000 hospitalizations
blamed on supplements.[2]
What the news coverage ignores about that study are the 20%
of injuries stemming from unsupervised babies swallowing their parents’
supplements, and another 40% comprising elderly people getting
supplement pills stuck in their throats. Other harms stemmed from heart
palpitations with supplements for energy, sexual performance, or weight
loss. A certain percentage stemmed from illegal ingredients. The FDA
already has the authority to remove adulterated products from the
market; indeed, DSHEA allows for the restriction or removal of any
product it determines to be unsafe. Supplements are further regulated by
the Federal Trade Commission and must also follow stringent good
manufacturing practices.
Also ignored in the scare story was any context – including
comparisons with drugs. While natural supplements allegedly “injure”
20,000 in a year, drugs approved by the FDA injure almost 2 million. One
over-the-counter drug, aspirin, harms in one year 60,000 people – more
than all dietary ingredients COMBINED. And the purported
supplement-injury figure does not fit with a similar study by the U.S.
General Accountability Office, which found a little over one thousand
annual harms from 2008 to 2011 – or the CDC’s actual database for
supplement adverse events, garnering barely over 3,000 in one year,
2012.[3]
Given the high safety of supplements, one cannot help but
ask why the government so persistently attacks the preference of
consumers for natural medicine. In the 2016 FDA redraft of the NDI rule,
they threatened to implement bankrupting safety and effectiveness
studies to be required whenever an old supplement is recommended for a
new population, or when using new manufacturing innovations, or when
proposing new doses. The first requirement isn’t even required of drugs,
which cavalierly are allowed to claim that they are “assumed safe for
children,” for example. The second requirement on manufacturing upgrades
will stifle supplement effectiveness, and as mentioned above
supplements already must adhere to strict manufacturing practices and
rules. The third requirement is the worst, however, as capping
supplement dosage will deny life-saving treatments so important in a
time of pandemic or really even any time.[4]
Given also that the FDA’s guidance would bankrupt the
supplement industry and jeopardize consumer health, why are some in
Congress colluding with the FDA to mandate supplement targeting? Perhaps
it stems from the FDA’s 1992 report on supplements, in which they
concluded that supplements threaten pharmaceutical companies’ pursuit of
patent monopolies.[5] Or, it could be a continuation of the past year’s
practice by the FDA to target with cease and desist letters those
entrepreneurs who sell supplements as COVID-19 treatments.[6] It seems
violative of the 1999 Shalala case – and of statutorily established
significant scientific-agreement claims – for the FDA to ban
dietary-supplement claims supported by credible scientific evidence.[7]
It has already happened with NAC, a decades-old supplement
that just happens to represent an effective COVID-19 treatment. Out of
nowhere, the FDA began issuing warning letters stating it is not a legal
supplement, reserving this essential health compound for the drug
industry alone.[8]
This draft guidance removes competition for Big Pharma and
will allow them either to monopolize the supplement market or more
likely to turn supplements into hugely expensive prescription drugs. If
consumers see that politicians and bureaucrats are interfering with
their supplements simply to line the pockets of the pharmaceutical
companies, they will not be happy.
And this brings forth a larger issue, the value of the FDA
itself. The FDA arguably killed half a million Americans in 2020 by
denying authorization for life-saving COVID-19 treatments. It has
proposed a supplement rule that will deny natural ingredients to half
the population. The National Health Federation proposes repeal of the
1962 FDA law that added “effective”-proving requirements of the sort
that the Agency would like to impose on supplements. Before the 1962 law
FDA only tested safety, after which the market could buy and sell
health treatments as long as consumers knew the results of such safety
testing.[9] We suggest that safety testing could even be performed by
non-FDA, independent private certification organizations. With safety
certification provided privately, consumers no longer would experience
the moral hazard of trust in a compromised and corrupted FDA brimming
with conflicts of interest whose approved drugs annually kill hundreds
of thousands of trusting Americans.
The FDA has long proven itself a danger to the supplements
it regulates, and to peoples’ health overall. Please oppose the FDA’s
and congressional efforts to remove from the market any supplements
using the New Dietary Ingredients guidance as the weapon to do so.
Action: Please input your zip code to send an email via NHF’s FDA Supplements Campaign:
The National Health Federation (NHF) is the
world’s oldest 501(c)(4) health-freedom organization, having since 1955
defended food and healthcare from government distortion and
special-interest corruption. For questions seehttps://thenhf.com/2020/11/03/who-is-nhf/ or contact lobbyist Charles Frohman, at 202-258-8027 or [email protected]
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