FDA Attacking Supplements Again

The FDA is now working to entangle the dietary supplement industry in a web of expensive and burdensome new regulations and requirements that are far in excess of those imposed on the drug industry.

It’s estimated that up to 50% of supplement companies will simply not be able to comply due to the huge added cost burdens, which means you’ll pay far more for every bottle of supplements you buy, and you’ll have 50% fewer companies to choose from.

In other words, the FDA is attempting to concentrate the dietary supplement community into the hands of a few large corporate manufacturers who can afford to comply with the added regulatory burden.

And simultaneously the FDA is attempting to reduce the number of new dietary supplements that can come to market, by making them harder to get approved than prescription drugs.

If these regulations are allowed to become law, be prepared to pay double, triple or maybe even quadruple what you’re now paying for nutritional supplements. Here’s what’s going on, and how you’ll be affected…

Hi, Steve Barwick here, for Targeted Nutrients…

Last month Consumer Reports published a massive attack on the use of nutritional supplements. They called nutrients “dangerous” and “untested,” and attacked the supplement industry as “unregulated” and “risky.”

Then, several weeks later, the FDA rolled out their proposed new regulations for supplement makers, claiming the new regulations will make supplements less risky and dangerous and will provide more regulation of supplement manufacturers.

Collusion, much? Yes, of course.

It’s no coincidence that first, one of the most popular consumer magazines in America features a cover article attacking nutritional supplements, using the FDA’s own talking points in calling them “risky,” “dangerous,” “untested,” “unproven” and “unregulated.”

Then, the FDA, waiting in the wings, steps in and proposes a host of burdensome new regulations to “protect” everyone from these supposedly risky, dangerous, unregulated and untested supplements.

The problem is, according to the Alliance for Natural Health and other industry observers, instead of making supplements “safer,” these new regulations will:

• Take thousands of existing supplements off the market, even though tens of millions of people have used them for decades with no adverse events

• Hinder brand new supplements from coming to market (the proposed new regulations make it harder to get new supplements approved than prescription drugs)

• Drive up to 50% of all supplement companies out of business (because the new regulatory burdens are so costly, only a small handful of large, corporate supplement companies will be able to afford to comply)

• Concentrate the supplement industry into the hands of just the few large corporate giants that can afford to comply with the costly new regulations

• Drive up your costs for supplements by double, triple or even quadruple (to cover the costs of the new regulatory burdens)

The problem, as you’ll see below, is that the charges being made against nutritional supplements in order to get these new regulatory burdens passed are completely bogus. Thankfully, the American public is finally figuring that simple fact out.

American Public No Longer Fooled

Indeed, the American public is no longer so easily fooled by such tactics. People are catching on. And they’re growing sick and tired of being manipulated by the powers-that-be and their news media lackeys.

For example, most adult Americans know that nutritional supplements are extraordinarily safe, on the whole.

And quite contrary to the FDA’s spurious charges that supplements are “risky,” “dangerous,” “untested” and “unregulated,” the reality is there have been ZERO deaths from nutritional supplements for nearly two decades, according to annual data from the American Association of Poison Control Centers.

Yet it’s quite the opposite when it comes to FDA-approved prescription drugs. According to the Journal of the American Medical Association, an average of 106,000 men, women and children die each and every year from supposedly “safe,” fully-regulated and “FDA-approved” prescription drugs that were properly prescribed, and properly taken.

That’s well over one million people every 10 years who end up dead from the proper use of lawful prescription drugs that were deemed by the FDA to be “safe” enough to sell to the general public.

Contrast that with the zero deaths from supplements in the same time period and I think you’ll see that the FDA’s charges against supplements fly in the face of reality.

Drugs v/s Supplements

As Dr. Joseph Mercola, D.O. has pointed out: If you take a nutritional supplement that disagrees with you, generally the worst that happens is a mild stomach ache, headache or temporary feeling of nausea that soon passes. But if you take a prescription drug that disagrees with you, quite often the very first (and last) symptom is sudden death.

That might explain why there are some 2.3 million drug-related emergency room visits nationwide each year, attributed to adverse reactions to pharmaceutical drugs that were taken as prescribed.

It might also explain why, when researchers for the New England Journal of Medicine decided to look into the number of emergency room visits attributed to nutritional supplements, they could only find a meager 3,667 cases in the 10 year period between 2004 and 2014.

During that same 10 year time-period there would have been some 23 million emergency room visits attributed to adverse reactions to FDA-approved prescription drugs.

Interestingly, the New England Journal of Medicine admitted openly that the vast majority of the emergency room visits for supplements they documented were either for “unsupervised children” who had ingested their parent’s dietary supplements, or for adults abusing weight loss supplements (which were said to be the cause of “71.8% of supplement-related adverse effects”), or from pills getting stuck in the throats of older adults who have trouble swallowing.

In other words, if you’re not a child…if you’re not abusing weight loss pills…and if you’re not an elderly person plagued with trouble swallowing pills…then you’re pretty darned safe taking nutritional supplements.

In fact, billions upon billions of nutritional supplement pills are swallowed each and every year by Americans, without harm.

So with that as background, let’s take a quick look at the three main charges the FDA and their news media lackeys such as Consumer Reports magazine routinely make against nutritional supplements:

Charge #1: Supplements are “risky” and “dangerous”

This is generally the very first charge you’ll see being made against supplements. But as you’ll discover below, the truth is quite the opposite.

According to annual data from the American Association of Poison Control Centers, there were ZERO deaths from nutritional supplements in the latest reporting period, including:

• Zero deaths for all forms of vitamins and multi-vitamins.

• Zero deaths from electrolytes, minerals and multi-mineral supplements (except for two deaths attributed to “sodium and sodium salts”).

• Zero deaths from amino acids.

• Zero deaths from botanical products (herbs).

• Zero deaths from all-natural “cultural medicines” (Chinese medicines, Ayurvedic medicines, etc.)

• Zero deaths from natural hormonal supplements.

• Zero deaths from homeopathic supplements.

• Zero deaths from “other dietary supplements”.

What’s more, you can go back some 20 years of annual data from the American Association of Poison Control Centers and find pretty much the same thing.

Occasionally, you’ll see data documenting that an individual died from abusing a weight loss supplement containing high levels of stimulants and diuretics (which are not really “nutrients”). Or you might see claims that the abusive use of a body-building supplement containing high levels of stimulants or
hormones (or both) caused a death. There have even been a few deaths over the years caused by the abusive use of energy drinks.

However, when the data is analyzed, and deaths from weight loss supplements, body-building supplements and energy drinks (which should never be called “nutritional supplements” in the first place) are eliminated, the death toll falls back to zero.

There are no deaths from multi-vitamins, minerals, amino acids, herbs, Chinese Traditional Medicine, Ayurvedic medicines, hormonal supplements, homeopathic supplements and “other dietary supplements.”

The reality is this:

Everything in life is potentially “risky” and “dangerous” to one degree, or another. But nutritional supplements have an absolutely remarkable history of safety and benefit.

The data shows there’s very little risk associated with supplement usage. Statistically speaking, driving to work in the morning is riskier than taking a nutritional supplement. In fact, your chances of being struck by lightning during the course of your lifetime are far greater than your chances of being harmed by a nutritional supplement.

Charge #2: Supplements are “untested and unproven”

The FDA and their media cronies continue to claim that supplements are “untested and unproven.” But as Andrew W. Saul, editor of Orthomolecular News has repeatedly pointed out, the FDA’s own website contradicts this charge. The FDA website states:

“Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.

That means that these firms are responsible for evaluating the safety and labeling of their products before marketing.

…FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.”

So the FDA prohibits the sale of supplements that are adulterated or misbranded, and puts the onus on the supplement manufacturer to make sure the supplements are safe and correctly branded before they can be sold.

If the supplement manufacturer fails to do so, the FDA can take legal action against them (and so can anyone harmed by the supplement). Indeed, with the stroke of a pen the FDA can cause any potentially unsafe supplement to be removed from the market.

In other words, just as the drug companies are held responsible for testing the drugs they bring to market, so nutritional supplement manufacturers are responsible for evaluating the safety and labeling of their products before bringing them to market.

And if a supplement turns out to be potentially unsafe, the FDA can quickly remove it from the market, as you’ll see directly below.

Charge #3: Supplements are “unregulated”

In reality, the nutritional supplement industry is heavily regulated. Supplements have to be manufactured in a FDA certified lab that complies with government-required GMP (Good Manufacturing Processes) regulations.

Indeed, once again, according to the FDA’s own website:

“FDA regulates both finished dietary supplement products and dietary ingredients.”

And by the way, supplements are considered to be food items. They’re designed to augment the nutrients we’re no longer getting in our foods, or that our aging bodies are no longer able to extract from foods and utilize fully.

That’s why they’re not regulated like drugs in the sense that you have to “prove they’re safe” before they can be sold. They’re basically food components.

But nutritional supplements being sold to the public do have to meet all label claims, or the supplement manufacturer can be prosecuted by the FDA for misbranding or mislabeling the product.

And supplement manufacturers do have to show the FDA, upon request, all laboratory analysis demonstrating that label claims are met, and that there’s no microbial contamination or contamination with other substances such as heavy metals. Otherwise, the manufacturer can be prosecuted for selling adulterated or contaminated dietary food items to the public.

And by the way, because supplement manufacturers are required by law to be federally GMP compliant, and because their manufacturing plants are routinely FDA inspected, they have to follow rigorous manufacturing practices designed for public safety.

Indeed, they have to document that they’re following these government-mandated practices on a consistent basis. And for each supplement batch manufactured they must produce lab analysis for the FDA to inspect upon request, or the FDA can shut down the manufacturer.

So the shop-worn charge that nutritional supplements are “unregulated” is as bogus as they charge that they’re “risky and dangerous.”

What’s more, the FDA can quite literally ban any nutritional supplement it so desires. For example, in November 2015 the FDA banned a popular nutritional supplement called Picamilon, even though after several decades’ worth of sales in the U.S. there’s no public record of even a single adverse event
reported from usage of the supplement.

The FDA simply arbitrarily claimed that Picamilon doesn’t fit the category of a “dietary ingredient.”

Of course, Picamilon is simply the vitamin niacin bonded to the amino acid GABA, both of which are DSHEA (Dietary Supplement Health and Education Act) compliant, and both of which have been sold as nutritional supplements for decades.

So this latest FDA ban on Picamilon leads to the growing probability that the FDA intends to go after numerous other nutritional supplements with dietary ingredients that are bonded, or chelated one to the other.

That means virtually all vitamins and minerals are at risk. As Jared Wheat, CEO of Hi-Tech Pharmaceuticals has ominously warned, “A lmost all vitamins and minerals are bound to some salt or compound for stability of the molecule and usually for better bioavailability.”

So what the FDA has done is begin looking for excuses to ban nutritional supplements even if the supplement has been sold for decades and even if there’s been zero reports of harm for that supplement from its users.

And one of the excuses they’re using is that when one supplement ingredient is bonded to another, that turns the supplement into a “drug” and qualifies it for removal from the supplement marketplace.

Balderdash

So, the idea that nutritional supplements are “risky,” “dangerous,” “untested” and “unregulated” and that the FDA’s hands are tied when it comes to overseeing the industry is complete and utter balderdash.

The simple fact of the matter is that the FDA can remove any supplement it wants from the market, basically with the stroke of a pen.

For example, only a few short years ago the FDA did the same thing to the active, pyridoxamine form of vitamin B-6, as well as to the P5P form of the same
vitamin. They simply arbitrarily declared it to be a “drug” and banned supplements manufacturers from selling it. Now, only the most poorly active form of vitamin B-6 is available to the public.

Of course, the removal of a nutritional supplement from the market can later be challenged in court by the supplement manufacturer. But how many supplement manufacturers have the money to go up against the comparatively unlimited funds of the federal government in court? Not many.

The Broader Level

On the broader level, Big Pharma and the ruling elite know very well that the less good nutrition a consumer can get into his or her body, the more prone that consumer will be to ending up at a doctor’s office with symptoms of a disease that requires prescription drugs.

Indeed, it was early in the twentieth century that the owners of today’s multinational drug companies began to realize that the less nutrition a person is able to obtain from foods or other sources, the greater the likelihood they’ll develop some form of disease that would require medication.

Hence, for the past two decades you’ve witnessed the ongoing battle by medical regulatory authorities (backed by Big Pharma) to restrict consumers from access to the best and most helpful nutrients.

The proposed new FDA regulations are the latest broadside in this battle to remove many existing supplements from the marketplace, restrict the development of new nutritional supplements, dramatically raise the costs of existing supplements, and concentrate the supplement industry into the hands of just a few big players who can afford the costs of the new regulatory burdens.

You can learn more about this developing situation, and send a message to the FDA and to your Congressional representatives at the same time, by visiting the website of the Alliance for Natural Health, here.

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