Big Pharma Wants to Put an End to Vitamins and Supplements
Below is an article by Dr Joseph Mercola we post for your knowledge and evaluation…
July 25, 2022 Puzzle Piece
STORY AT-A-GLANCE
- One
of the latest attempts to thwart your ability to access nutritional
supplements comes in the form of draft legislation that would require
premarket approval for dietary supplements. In short, it would require
supplements — which are food — to undergo the same approval process as
drugs
- In
the past, the drug industry and the U.S. Food and Drug Administration
has tried to ban certain supplements, including vitamin B6 and
N-acetylcysteine (NAC), by reclassifying them as new drugs
- Another
strategy the drug industry has been using to gain a monopoly over the
supplement industry is to buy up supplement brands. Just 14 mega
corporations — many of them drug companies — now own more than 100 of
the most popular supplement brands on the market
- This
monopoly over the supplement industry gives drug companies enormous
regulatory influence, and that’s a way by which they could eliminate
independent supplement makers who can’t afford to put their products
through the drug approval process. Indeed, it seems that’s what the
Durbin-Braun premarket approval proposal is trying to accomplish
- Take
action to protect widespread access to dietary supplements. Contact
your Senators and urge them to oppose the Dietary Supplement Listing Act
of 2022, and its inclusion in the FDA Safety Landmark Advancements Act
The Durbin-Braun Premarket Approval Proposal
A discussion draft of the legislation was released by the United States
Senate Health, Education, Labor, and Pensions Committee (HELP) in
mid-May 2022.
As reported by Vitamin Retailer:
"On May 17 [2022], the United States Senate Health, Education,
Labor, and Pensions Committee (HELP) released a discussion draft of its
legislation to reauthorize FDA user fees for drugs, biologics and
medical devices package, which includes the controversial and divisive
Durbin-Braun premarket approval concept and more that would be damaging
to the industry, according to the Natural Products Association (NPA).
'The NPA is significantly concerned with Chair Murray and Republican
Leader Burr who failed to reject the radical and dangerous legislation
from Senators Durbin and Braun that would require premarket approval for
dietary supplements and weaken key privacy protections of the
Bioterrorism Act, which protects the dietary supplement supply chain,'
said Daniel Fabricant, Ph.D. president and CEO of the NPA.
"Last time I checked, dietary supplements are not drugs, biologics
or medical devices, so why Congress or anyone supporting nongermane
legislation that will only add costs to consumers who are doing all they
can to stay healthy is extremely troubling."
Groups who [sic] have supported this legislation, have stated there
are protections for technical disagreements with the FDA like those with
hemp, CBD, NAC, and several other products. However, if this
legislation were to pass, it is abundantly clear these products would be
eliminated from the market.
For years, the drug industry, with the U.S. Food and Drug
Administration's support, has tried to get nutritional supplements off
the market. One of the most often used tactics has been to try to
reclassify them as drugs.
Usually, they would target specific nutrients that stood in their way of
profits, but legislation such as the Durbin-Braun premarket proposal
would allow the drug industry to monopolize the market in one fell
swoop.
Big Pharma Tried to Ban Vitamin B6
The fight over vitamin B6 (pyridoxine) is one example of how Big Pharma
tried to eliminate a natural substance that stood in the way of a drug
patent. In 2007, Medicure Pharma submitted a citizen's petition to the
FDA in which it argued that any dietary supplement containing pyridoxal
5'-phosphate — vitamin B6 — were "adulterated" under the Federal Food,
Drug and Cosmetic Act, article 402(f).
In essence, Medicure wanted all vitamin B6 products banned, because they
undermined the company's incentive to continue development of it's drug
version of B6.
Medicure had gotten wise to vitamin B6's effectiveness against ischemia
(inadequate blood flow) and decided to make a drug out of it by simply
renaming the vitamin "MC-1." They entered it into the drug bank and then
argued that B6 supplements contained "their" MC-1. The drug bank even
admits the renamed vitamin B6, i.e., MC-1, is:
"... a biologically active natural product which can be regarded as a
chemical entity that has been evolutionarily selected and validated for
binding to particular protein domains."
The main reason why drug companies engage in this kind of sleight of
hand is because once a substance is classified as a drug, you can jack
up the price by 1,000% over the supplement's typical retail.
FDA Cracking Down on NAC
Perhaps the most recent example of the FDA trying to shut down easy
access to nutritional supplements was its 2020 attack on
N-acetylcysteine (NAC). NAC has been a widely-used dietary supplement
for six decades, yet the FDA suddenly decided to crack down on it in
late July 2020 — right after it was discovered how useful it was for the
prevention and treatment of COVID-19.
According to the FDA, NAC was excluded from the definition of a dietary
supplement because it had been approved as a new drug in 1963.7 But if that was the case, why did they wait until 2020 to take action?
As reported by NPI at the time, there were more than 1,170
NAC-containing products in the National Institutes of Health's Dietary
Supplement Label Database when the FDA started sending out warning
letters9 to companies that marketed NAC as a remedy for hangovers.
Members of the Council for Responsible Nutrition also worried the FDA
might start to target NAC more widely. So far, that hasn't happened, but
Amazon immediately stopped selling all NAC products after those warning
letters went out, whether the sellers marketed it as a hangover remedy
or not.
Also, the selection of "hangover" for those warning letters seemed
arbitrary at best. The fact is that several scientists had called
attention to NAC's benefits against COVID, and shortly afterward, the
FDA came up with this ridiculous excuse to limit the availability of it.
It just smacked of conflict of interest.
Another Way Big Pharma Is Seeking to Take Over
Another strategy the drug industry has been using to gain a monopoly
over the supplement industry is by simply buying up supplement brands.
Nestlé Health Science, for example, has acquired Garden of Life, Vital
Proteins, Nuun, Pure Encapsulations, Wobenzym, Douglas Laboratories,
Persona Nutrition, Genestra, Orthica, Minami, AOV, Klean Athlete and
Bountiful.
Bountiful, in turn, owns brands like Solgar, Osteo Bi-Flex, Puritan's
Pride, Ester-C and Sundown, all of which are now under Nestlé's control.
The Bountiful brands alone generated net sales of $1.87 billion in the
12 months ending March 31, 2021, so the $5.75 billion agreement to
acquire a majority stake, signed in August 2021, didn't necessarily burn
a big hole in Nestlé's pocket. According to J.P. Morgan analyst Celine
Pannuti, quoted by Natural Products Insider:
"Through the acquisition of The Bountiful Co., Nestlé can build a
'leading position' in the 'fragmented category' for vitamins, minerals
and supplements, which 'has delivered the highest and most consistent
growth in consumer health care over the past 10 years."
The 'Free Market Competition' Lie
In all, a mere 14 mega corporations — many of them drug companies — now
own more than 100 of the most popular supplement brands on the market.
The graphic below is from Neal Smoller, PharmD, the holistic
pharmacist's website.
It doesn't show the ownership of all available brands, but it gives you
an idea of just how small the ownership circle has become. As noted by
Smoller, many competing brands are even owned by the same corporation,
rendering the notion of free market competition null and void.
Importantly, owning the lion's share of supplement companies puts the
drug industry in a unique position to get rid of them whenever they so
desire. They could intentionally make the company tank simply by cutting
advertising, for example. Cutting quality could have a similar effect,
while simultaneously cheating customers who rely on dietary supplements
for optimal nutrition and health.
Most important of all, however, this monopoly over the supplement
industry gives drug companies enormous regulatory influence, and that's a
way by which they could eliminate independent supplement makers who
can't compete financially. Indeed, that seems to be what the
Durbin-Braun proposal is all about.
Supplements Have Phenomenal Safety Profiles
This new proposed legislation would technically ban most supplements, as
few supplement makers have the financial resources required to meet
drug approval requirements. The only ones with pockets deep enough to do
that would be the mega-corporations.
Putting vitamins and nutrients through the drug evaluation and approval
process would automatically eliminate many supplements from the market
and result in higher retail prices for whatever remains. It would also
allow drug companies to rename basic nutrients, label them drugs, and
jack up the price even further.
We cannot let this happen. Dietary supplements are FOOD, plain and
simple. They should not be treated as drugs, which must undergo rigorous
testing to evaluate effects and safety. Supplements have a long history
of near-spotless safety and don't need drug-style testing.
Supplements Are the Safest Foodstuffs Available
Deaths associated with use of dietary supplements are extremely rare
compared to the death toll from prescription drugs, yet supplements are
routinely singled out as being potentially dangerous, either due to lack
of testing, lack of regulation or both. The thing is, supplements don't
need safety testing, as they are food, and they are, in fact, fully
regulated.
In 2015, CBC News published a Marketplace report in which they claimed a
number of supplement makers had ripped off customers by failing to live
up to the claims on their labels. Two months later, they had to retract
the report,16 when it was proven their tests were
inaccurate. That's just one example of how the pharma-owned media tries
to give supplements a bad rap.
Nutritional supplements are the safest foodstuffs available; adverse
reactions to pharmaceutical drugs are 62,000 times more likely to kill
you than nutritional supplements.
Meanwhile, in the real world, not a single death has ever been reported
as a direct result of taking a supplement. On the contrary, data
provided in a 2012 report by the UK-based Alliance for Natural Health
International (ANHI), showed nutritional supplements are the safest
foodstuffs available.
Your risk of dying from an herbal product or dietary supplement is less
than 1 in 10 million, comparable to your risk of being killed by
lighting.
ANHI also calculated that adverse reactions to pharmaceutical drugs are
62,000 times more likely to kill you than nutritional supplements.
So, the one thing that can be conclusively said about supplements is
that they may be the safest category of any consumable product. On the
whole, junk food and drugs are FAR more likely to harm or kill you.
What's more, lack of human trials does not mean supplements are
unregulated. They're regulated by both the FDA and the Federal Trade
Commission (FTC). The FDA regulates the finished product and individual
ingredients, while the FTC regulates the advertising of supplements. So,
while not regulated as drugs, but rather as a food, they are fully
regulated.
Take Action NOW to Protect Your Supplements From Disappearing
As noted by NPA president and CEO, Daniel Fabricant:
"The war is far from over. We need America's health and wellness
advocates to continue writing their members of Congress through the NPA
Action Center. Grassroots involvement over the coming weeks is
absolutely critical to defeating this radical and dangerous proposal."
I join Fabricant in urging you to contact your senators and urge them to
oppose the Dietary Supplement Listing Act of 2022, and its inclusion in
the FDA Safety Landmark Advancements Act.
If you take supplements and you want to continue the freedom to take
them in the future, it is VITAL that if you live in the U.S. that you
let you representatives know. Not only would I email them in the link
below (be sure to customize it and change it) but I would also call your
representatives! It worked previously and will work now, but you need
to be involved.
Alternatively, you can take action by sending an email. The Alliance for
Natural Health makes it easy on SaveSupplements.com. Phone calls are
more effective, but if for some reason you don't want to call, Alliance
for Natural Health has created a prewritten email that will be
automatically sent to the U.S. president, senators and representatives.
Yours in Health and Wellness,
John W Brimhall, DC, FIAMA, DIBAK, Formulator
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