At first glance the push for more formal vitamin and supplement regulation in the US appears like a pursuit pleasing to consumers of these health products. A closer look below the surface, however, reveals such a move is not favorable to the interests of the public at large.
(NOTE: An abbreviated version of this article has been published in the peer-reviewed publication Orthomolecular Medicine News Service (OMNS), a non-profit, non-commercial informational resource, as "Regulation of Vitamins: Politics As Usual" by Rolf Hefti, Vol. 10, No. 2, 7-January-2014 [direct link: http://orthomolecular.org/resources/omns/v10n02.shtml])
"Patient safety and public health should be bipartisan and above politics. But that is not what is happening [...]." (David J. Graham, MD, FDA Whistleblower)
Supporters of more stringent supplement regulation, spearheaded by government health agencies, such as the U.S. Food and Drug Administration (FDA), and representatives of conventional medicine, promulgate their perspective with allegations that the available supplements are a significant public health threat because they are poorly regulated for safety (and effectiveness), thus need to be FDA approved .
More rigorous policies of food supplement regulation, exemplified by formal testing of vitamins guaranteeing product safety, are perfectly reasonable and called for:
So, are dietary supplements safe, are the harms inflicted by vitamin side effects a profound problem in the United States?
The facts about vitamins illustrate that broad (serious) vitamin toxicity is certainly not an issue despite lax regulatory affairs and laws on dietary supplement safety (discussed in other articles of mine, such as Health Risks Of Dietary Supplements | The Proper Perspective and Dietary Supplements And Risks | The Attacks On Supplement Safety).
Therefore, the justification for FDA regulation of nutritional supplements, to have them officially reviewed as prescription drugs because of vitamin toxicity, is wrong, bamboozling and enticing the public into endorsing a mistaken proposition.
Now, let's scrutinize the US government drug-approval process, the medical product testing system vitamins would be reviewed under per the proposed new rules of supplement regulation...
"Every civilization believes in its own propaganda. So it tends to emphasize the light side, and forgets about the shadows." (Morris Berman, PhD, Social Critic & Author)
Alluding to Berman's statement above, the public health authorities (like the FDA) and the conventional medical industry continue to remind the public how stringent and solid the decrees are regulating traditional medical products and services such as pharmaceutical medications. For example the FDA announced that:
“Prescription drugs must undergo clinical testing and receive the FDA's full review for safety and effectiveness before they are sold.” 
Henceforth, advocates of the medical orthodoxy, and “evidence-based” medicine (EBM) in particular, press for supplement regulation mandating that natural health supplements get rigorously tested and approved for safety and efficacy, akin to prescription drugs and other medical interventions .
Yet, the fact remains that:
“[...] many treatments used in conventional medicine have not been rigorously tested, either, […].”  [emphasis added]
But much larger, pitch-dark "shadows" lurk the mainstream medical culture "forgets" to mention to the public...
The proper administration of all prescription drugs, products supposedly backed by randomized controlled studies and clinical drug trials, and...
... approved by the FDA for “for safety and effectiveness before they are sold”(!)...
... kills over a hundred thousand people every year in the US [4-9].
And, the government agency has full knowledge about this enormous human damage...
The Institute for Safe Medication Practices (ISMP), a "nonprofit organization devoted entirely to medication error prevention and safe medication use" (quoting from their official website), scoured through the FDA databases of serious adverse events associated with prescription drug therapy during the year of 2011 [79,80]. The analysis of the ISMP concluded that 2-4 million persons suffered serious injuries, including 128,000 deaths, pointing out that "drug therapy stands as one of the most significant perils to health resulting from human activity" . Facts even admitted to and verified by the FDA at their official website  but without this federal institution of "public health protection" taking any responsibility for the appalling reality authorized ("FDA-approved") and enabled by them.
In a 2013 interview the cofounder of The Cochrane Collaboration and medical scientist Peter Gøtzsche, MD, described the grim situation in unmistakable terms:
"First of all, the public needs to know the extent to which they are being deceived in the current system, e.g. few people know that prescription drugs are the third major killer. If drug testing and drug regulation were effective, this wouldn’t happen."  [emphasis added]
Do you know of any sound incontrovertible facts that make you think additional vitamin supplement regulation and federal oversight is a public priority over effective drug regulation?
No surprise, the traditional medical profession and the FDA never show the public a (genuine) risk comparison between pharmaceutical drugs and nutritional supplements.
The mainstream medical establishment, and its apostles, like to promote the propagandistic notion that the supplement world is a great risk to the public (e.g., with accusations that vitamins increase mortality) when in actuality modern medicine (allopathy) is one of the top leading causes of death -in both the US and Europe . It's analogous to how the ruling US elite promotes the deceptive perception that foreign terrorists create huge (potential) harm to the American people when the US bureaucrats have routinely approved (and keep doing it) the killings of massive numbers of civilians in foreign nations .
Politics trumps the facts of the real world.
The claims of the medical officialdom about the urgent need for better supplement regulation, that is, to have FDA approval for “safety and efficacy”, is nothing but empty rhetoric, camouflaging what the real enemy is to the public within the health care industry. One could rightly say that the call for increased federal supplement regulation is the ultimate "straw man argument" commonly brought up by vitamin opponents. It's the type of disingenuous information the medical authorities habitually feed to the public while the "uncomfortable" facts of the real world ("the shadows") are overlooked and remain undisclosed ("forgotten", to utilize Berman's term).
The Council for Responsible Nutrition (CRN), a trade association representing the vitamin industry, concurred in one of their reports:
“Pre-market approval is not a guarantee of safety as witnessed by those drug products that have been approved by FDA, only to be later recalled due to safety concerns.”  [emphasis added]
In a report by a seemingly reliable investigator (and purportedly Mensa member) -in which he implied to possess common sense- he hails the stringent FDA drug-certification system but admits the process “still fails occasionally” . As if the “occasional failing” of something is a dependable marker or guideline about the magnitude of harm something causes.
What matters most is the extent of damage something causes, not whether it fails a lot, occasionally, or almost never.
If the occasional or very rare failure (or destruction) of just one nuclear reactor plant, officially declared (i.e., propagandized) as very safe, leads to the death of at least a million people as in the catastrophe of Chernobyl , should it be embraced and utilized?
Shockingly, this Mensa member, presumed to ooze superior intelligence, uses the names of drugs, such as Vioxx, Bextra, and Fen-Phen, in the same sentence where he applauds the rigorous FDA-drug approval system (as he essentially described it)! Vioxx (rofecoxib) alone had caused 60,000 deaths and other serious injuries  -and there are estimates of well over 100,000 deaths [15,16]. The death toll is about equivalent to the numbers of US soldiers who died during the entire Vietnam war . This Mensa laureate does not recognize his foolishness or the irony in what he writes, or shall I say his lack of common sense?
I wonder at what point he deems a testing program for drug safety faulty, gravely inadequate, and destructive if he thinks the current FDA approval system needs respectful recognition and acclaim.
A loyal spokesman of the traditional medical industry, Dr. Paul Offit, dispensed a comparable preposterous statement in regard to Vioxx -or vitamins, respectively. In a CNN interview Offit proclaimed about the scope of natural supplement toxicity:
"If you look at the data on megavitamins, large doses of vitamins, I think it's worse than Vioxx [...]." 
(The research data show the total opposite of what Offit "thinks" and claims.)
Aside the absence of medication safety, damning evidence on the serious lack of effectiveness of the medical industry's pharmaceutical medicines is also abundant:
Moreover, "effectiveness" and "benefit" aren't necessarily the same. A medical drug might get rid of a particular symptom by inhibiting a certain enzyme system, an outcome the medical orthodoxy declares a sign, a marker, or proof of effectiveness or "a cure", while the overall therapeutic result of the drug-induced physiological interference is higher mortality, representative of "inconvenient" side effects that frequently are not (properly) acknowledged and tabulated in risk-benefit analyses of "scientific" studies (e.g., see my digital book "The Mammogram Myth").
It's "effectiveness" by toxicity. It's a lack of real benefit because of toxicity.
As a senior FDA scientist admitted:
"Of critical importance, the efficacy of a drug usually has little or nothing to do with its benefit." 
"[...] [benefit] is something FDA doesn't measure [...]. [...]. So, when FDA approves a drug, it usually has no evidence that the drug will provide a meaningful benefit to patients."  [explanation & emphasis added]
The pharma industry is fully aware of this too. A former veteran pharmaceutical industry representative ("drug rep"), Gwen Olsen, admitted in an interview about the drug companies that:
“The industry knows that many of their drugs aren’t safe and that they don’t heal people. In fact, some drugs are designed to make symptoms worse later on.”  [emphasis added]
Allen D. Roses, MD, a former research vice president at a large pharmaceutical company, GlaxoSmithKline, stated at a scientific conference that the vast majority of prescription medicines provide no benefit to most patients .
Allegedly, the FDA's job is to make sure "snake oil" medicines aren't getting sold to the public. But clearly, the "forgotten" facts of the real world demonstrate it is a very common practice for the FDA to approve medical drugs that are harmful or non-beneficial (i.e., "snake oil" concoctions) [1,14,20,23,24].
The practical conception of the FDA goes back to 1906:
“Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, […].” (Official U.S. Government FDA website, accessed Oct. 2011)
Ironically, it was supposedly the potential public exposure to unsafe drugs, and "snake oil" products like patent medicines ("home remedies" or “cure-all” elixirs), that prompted the federal government to create the FDA [28,58]. But even at that time (just like today) the biggest threat to public health were the toxic drugs and products from the medical orthodoxy rather than alternative health remedies, even after accounting for the significant disproportionate ratio of orthodox-to-unorthodox medical practitioners .
It seems to indicate that the FDA, throughout its entire history, has never protected the public from the worst threats to their health, casting doubt on the declared justification for its formation.
"In order not to arouse suspicion, the [orthodox medical] industry has erected a screen. That screen is the GOVERNMENT. This impostor with all the airs of a saint coming to our aid, has betrayed us for the sake of profit for the industry." (Ghislaine Lanctôt, MD, in 2002 ) [explanation added]
In terms of supplement regulation, many or most people are surprised to learn that the FDA does not test natural vitamins and supplements.
But even more people are surprised to learn that the FDA also does not routinely test pharma drugs as the agency merely relies on the "scientific" data provided by the drug companies, and FDA-commissioned review panels are commonly outfitted with members who have financial ties to the pharma industry [1,31,32,83].
However, shouldn't the public feel primarily betrayed and deceived by the federal public health organization because of their claim that these medical products are fully approved by them for safety and efficacy yet they're killing and seriously injuring an enormous number of people, and because the FDA has been creating the public impression and understanding that they're dedicated to looking out for the public's health and that they're operating as an independent "objective" entity separated from the medical business?
In short, the FDA -or most precisely, the medical-federal-industrial complex- has given itself a license to systematically lie to the public about (1) themselves and (2) about medical products that are actually and factually among the most destructive items on the market and that a large percentage of people consume regularly. This means that the FDA drug approval process is basically an industry/government-sanctioned scam.
According to investigator and author G. Edward Griffin, any orthodox medical treatment or drug advocated as “proven” to work and to be "safe" in scientific study trials has merely received the FDA's "stamp of approval":
“It is important to know, […], that the successful completion of those tests does not mean, as the terminology implies, that the therapy is safe and effective. It merely means that tests have been conducted, the results have been evaluated, and the FDA has given its approval for marketing, often in spite of the dismal results. If […] patients undergoing these FDA-proven therapies were to read the actual laboratory reports, they would recoil in horror.” 
Jonathan W. Emord, Esq, a constitutional lawyer, explained in an article that:
“Most Americans are shocked to learn that the FDA is not mandated to test any proposed new drug to determine if it is safe. Instead, the FDA relies on the drug companies to inform it if they find evidence of safety.”  [emphasis added]
A FDA whistleblower chronicled that:
"The fact that FDA has never performed a formal benefit analysis does not stop it from proclaiming to the world that for a particular drug with a well-defined and serious side effect, that the benefits exceed the risks. This [...] is propaganda and deception."  [emphasis added]
Emord pointed out that:
“In a 2009 Department of Health and Human Services Inspector General survey of 400 FDA scientists, 66% maintained they lack confidence that the FDA adequately monitors the safety of prescription drugs. Eighteen percent of those surveyed stated they were pressured by FDA management to approve or recommend a drug despite their reservations about its safety, effectiveness, or quality.” 
Marcia Angell, MD, former editor of The New England Journal of Medicine (NEJM), mentioned this in a paper:
“[...] most important, many members of the standing committees of experts that advise the FDA on drug approvals also have financial ties to the pharmaceutical industry.” 
Similarly, and apparently still true after the passing of the first decade of the 21st century, David G. Williams, DC, stated in an article:
“It should be obvious to everyone by now that drug safety testing is nothing more than a well-orchestrated scam designed specifically to gain FDA approval. […]. We see time and time again that drug studies are far too short (by design, I might add) for any serious, long-term side effects to show up.” 
The pharmaceutical industry is actively funding a very sizable slice of the FDA's budget since the introduction of the Prescription Drug Users' Fee Act (PDUFA) in 1992 [14,34]. In 2007, industry funding was reported to account for more than 50% of the entire "drug review budget" of the FDA . Basically, the PDUFA “put the FDA on the payroll of the industry it regulates” . Or, the PDUFA sealed the FDA's designation as a political captive of corporate medicine . Of course this means the FDA is not going to (frequently) bite the hand that feeds it -quite the contrary [1,23,35].
In essence, the PDUFA allows pharmaceutical manufacturers, in exchange of paying the FDA a steep fee for every drug application, to get new drugs approved by the federal agency in a much faster time period [36,37].
The result is drugs end up in the marketplace sooner, which is good for the profits of drug companies.
Unfortunately, because FDA drug reviewers have to scrutinize a myriad of medical data for each drug application within a shorter time span, this led to a situation whereby ineffective and unsafe drugs get approved more often, causing tremendous harm to people [24,36]. A senior FDA official announced this cozy juridical arrangement of drug regulations equates to "guaranteed homicide" .
By the way, the PDUFA had not been initiated and requested by the public or the FDA. The pharmaceutical industry instigated the petition under the specious pretext the FDA is stalling the prompt release of life-saving medicines to Americans when in fact most new drugs provide no meaningful medical advances over existing (cheaper) drugs [14,24].
Decades later this is still true.
For example, data analyses of the prices of dozens of cancer drugs approved in the United States between 1995 and 2013 revealed that the prices had increased by an astounding 12% per year yet the newer medications didn't improve survival numbers compared to the older, less "advanced" drugs . Some people had called this public gouging scheme "The Drug Pricing Racket" .
The money (“fees”) paid to the FDA by the pharmaceutical-medical industry in 2010, as an example, amounted to over half a billion US dollars .
To the question as to why the FDA which approves all medical drugs “for safety and effectiveness before they are sold” but in the real world severely harm and kill absolutely staggering numbers of people every year from serious adverse drug reactions can be so incorrect about these very same drugs, Barbara Starfield, MD, (1932-2011), replied:
“[...] it cannot divest itself from vested interests. [There is] a large literature about this, mostly unrecognized by the people because the industry-supported media give it no attention. […], the fact is that more and more unsafe drugs are being approved for use. Many people attribute that to the fact that the pharmaceutical industry is (for the past ten years or so) required to pay the FDA for reviews---which puts the FDA into an untenable position of working for the industry it is regulating. […]. The problem is that we do not have a government that is free of influence of vested interests.”  [emphasis added]
Emord, too, pointed out in 2010 that:
“Drug industry money fills the coffers of Republicans and Democrats on the Hill.”
The FDA (and other branches of the US government) is buried up to the neck in conflict-of-interests [1,23]. Some people prefer calling the mutually self-serving relationship between the bureaucratic agency and the medical-pharmaceutical industry corruption, fraud, or "organised crime" . (The same sort of sham exists in Europe due to the transnational global reach of the large corporate industries .)
Longtime consumer advocate and former presidential candidate Ralph Nader pronounced in an interview:
“If you take departments of commerce, interior, agriculture, treasury, food and drug administration, auto safety agency, the FAA, the defense department, the state department...corporate power is the overwhelming force, both with their own executives in high positions in these departments and with their lobbyists and their campaign contribution.”  [emphasis added]
Another ostensible hallmark of the pervasive existence of vested interests among these influential entities of official authority is the common "revolving door" mode of operation between government and corporate organizations:
“The Food and Drug Administration (FDA) is a government agency whose supposed job is to "protect" the public from dangerous drugs, foods, medicines, toxins, and medical procedures. In fact, the FDA is a gestapo-type organization only serving the interests of the major drug companies and medical establishment. The various senior members of the FDA rotate lucrative positions on the boards of major drug companies and other key organizations.” 
Similarly, Richard A. Passwater, PhD, an award-winning research biochemist who has been intimately involved with the wellness industry for decades, noted:
“On many occasions, former FDA staffers have gone on to lucrative positions with pharmaceutical companies. This well-known “revolving door” arrangement suggests a conflict of interest between the regulator and the wealthy and powerful drug companies it is supposed to regulate rather than protect.” 
Or the other way around, executives in high positions at pharmaceutical companies routinely end up as heads of federal agencies:
“Just witness its recent hiring of Johnson & Johnson’s [=drug company] executive Spielberg who was tapped by FDA Commissioner Margaret Hamburg, as the latest deputy commissioner within the Office of the Commissioner to oversee the Agency’s drug and device centers. This is not an exception, this is the rule.”  [explanation added]
Pertinent research data found with conflict-of-interests comes significant bias:
“The greater the financial and other interests and prejudices in a scientific field, the less likely the research findings are to be true.” 
Or in perfect analogy...
"The greater the financial and other interests" in a government setting [see Emord's opening quote of this section], "the less likely" authoritative labels, like FDA approved for safety and effectiveness, "are to be true."
Or most succinctly...
Follow the money, and you will find where (most likely) the truth is not.
With the endless initiatives for FDA dietary supplement regulation we have uncanny evidence of bias (i.e., favoritism) towards the medical-pharmaceutical establishment.
Attorney Jonathan W. Emord, Esq, who specializes in constitutional and administrative law, especially FDA law, remarked in an interview as to why he wrote the book “The Rise Of Tyranny” (2008) in which he depicts the abuse of power by the FDA:
“I have been a close witness to corruption and abuse of power at the FDA. […]. I wanted to show that FDA is a classic example of industry capture wherein the pharmaceutical industry has such influence over FDA’s political appointees (from the Commissioner on down) that it causes drugs that are too unsafe to enter the market to be approved by FDA nonetheless, resulting in serious injuries and deaths."  [emphasis mine]
"I wanted to reveal that FDA has so much power and no real check on its exercise that it operates outside the Constitution, unanswerable to the courts, the Congress and the American people." 
"I wanted to give specific examples, demonstrating that FDA political management had overruled its medical reviewers safety objections and had authorized the introduction into the market of over a dozen drugs that have caused serious injury including, among others, Redux, Rezulin, Avandia, Vioxx, Ketek, Paxil, Zoloft, Effexor, Omniflox, Trovan, Baycol, Bextra, Seldane, Propulsid, Accutane, Arava, Crestor, Meridia and Serevent.”  [emphasis mine]
The FDA, however, flat-out lies to the public by falsely proclaiming it's free of financial conflict-of-interests, objective in its product review process, and only approves safe and effective products:
“Requiring prior FDA review and authorization of disease claims ensures that such claims will be evaluated by a public health agency that has scientific and medical expertise so that only products that are safe and effective will be permitted to be sold for therapeutic purposes. As a government agency with no financial stake in either permitting or denying claims, FDA is in a position to evaluate the strength of the safety and efficacy evidence objectively.” (Federal Register, Final Rules, Rules and Regulations, Docket No. 98N-0044 (FR Doc. 00-00053 ), Vol. 65, No. 4, Pg. 1039, January 6, 2000, Official U.S. Government FDA website [accessed 3-Dec-2013])
Are you still unsure, vague, or confused about who the public health authorities are (predominantly) trying to protect?
"[...] the biomedical and pharmaceutical companies essentially own the FDA. It is a classic case of capturing the regulator, transforming a public watchdog into an industrial attack dog. Consequently, the FDA’s general philosophy is protecting and promoting drugs and other lucrative products sold by its rich patrons, and wiping out natural remedies and other inexpensive health solutions." (Wade Frazier, Investigator & Writer)
The declared intent, or aim, of the FDA is to protect public health as it reportedly calls itself "the world's leading consumer protection agency" . That's what the agency wants the public to believe about it. The FDA's actions, its mode of operation, belie this in the most profound and fundamental way possible .
A notorious example of FDA's failure to protect the health of the public is its "seal of approval" of cigarettes and other tobacco products, going on for roughly a century.
In the 2010 Surgeon General's report on tobacco and health it explicitly explained:
“In the nearly 50 years since , extensive data from thousands of studies have consistently substantiated the devastating effects of smoking on the lives of millions of Americans.”  [explanation added]
“[...] this 2010 report […] explains beyond a shadow of a doubt (irrefutable data) how tobacco smoke causes disease […].” 
“There is no risk-free level of exposure to tobacco smoke, and there is no safe tobacco product. […]. When individuals inhale cigarette smoke, either directly or secondhand, they are inhaling more than 7,000 chemicals: hundreds of these are hazardous, and at least 69 are known to cause cancer.” 
“[...] in the United States, tobacco use remains the single largest preventable cause of death and disease for both men and women.” 
In spite of the mountain of unshakable evidence against the use of tobacco products, starting to appear in the mid-late 1920s, in spite of the “irrefutable data” that smoking causes incredible harm and countless deaths, the FDA still has not banned the deadly tobacco goods.
(Incidentally, regarding smoking tobacco and the causes of lung cancer, it was Nazi Germany's Third Reich scientists who first established definite proof, during the 1920s and 30s, that tobacco smoking is the major culprit of this type of cancer . Although the bulk of their meaningful research studies were generally ignored or brushed aside by medical historians and the rest of the industrialized world because of their association with the Nazi regime, despite that German cancer research was the most advanced anywhere at that time . As a result, the Nazi medical-military leaders implemented "the world's strongest antismoking campaign" because they were most concerned about protecting the health of the Aryan race, the purportedly superior human kin .)
Moreover, since 2009 the FDA has statutory power of the regulation of tobacco products “to protect and promote the health of the American public” .
The Surgeon General's report also pointed out the tremendous addictive quality of tobacco products:
“[...] nicotine compares with heroin and cocaine in its hold on users and its effects on the brain.” 
Notwithstanding, heroin and cocaine are banned (illegal substances in the US), while nicotine, a highly addictive drug, is freely available -similar to pharmaceutical interventions that kill and severely injure astronomical numbers of people, year after year.
A health journalist and author wrote this in one of his works:
"The people who control the liquor and tobacco industries and who push their products in lavish advertising sprees would have to be as morally corrupt as any jungle drug baron, but instead of being hounded by the law they are looked upon, often in admiration, as dynamic and successful businessmen. [...]. [...] there is a more insidious and widespread drug danger to humanity than all the others put together, and that is the ever-increasing consumption of pharmaceutical products which, in terms of money, corruption and danger, makes the operation of jungle drug barons look like chickenfeed. The pharmaceutical companies don't just target impressionable teenagers for their next crop of addicts; they target everybody, young and old." 
Best-selling author Eric Schlosser had poignantly revealed this hypocrisy, twisted reality, and fraud when he stated that:
"Some of the nation's worst drug dealers aren't peddling on street corners, they're occupying corporate suites."
Thus, in consideration of the facts of the real world (e.g., FDA corruption), James Howenstine, MD, heeded:
"It is foolish to think that the FDA is concerned about the health care of the citizen when their primary allegiance is to the pharmaceutical industry and allied monopolistic businesses." 
"The thing that bugs me is that people think the FDA is protecting them. It isn't. What the FDA is doing and what the public thinks it's doing are as different as night and day.” (Herbert L. Ley, Jr., MD, 1923-2001, Former FDA Commissioner, in 1970) [emphasis added]
Some investigators nicknamed the FDA ”The Federal Death Administration”. Do you think this sounds outlandish? Think again...
Because... as Emord had pointed out:
“Unlike many other regulatory agencies, decisions made by the FDA Commissioner can determine whether people live or die.”
Like with the FDA's arbitrary, capricious drug authorization system.
Arguably most incriminating, however, are the numerous personal accounts of FDA scientists about "the inner workings" of the famous federal agency.
In 2009 a number of scientists employed at the FDA sent a six-page letter of concern and discontent to the President and his team , accusing the FDA agency of:
History is ominously void of meaningful "change and reform at the FDA" (just read this section's opening quote by Dr. Ley from 1970). A strong call to stop genetic engineering (to produce genetically modified organisms or GMOs) because of serious public safety concerns had also been issued by some of the agency's own scientists at around 1990 which the leadership of the FDA totally ignored because the private interests of the GM industry were in danger to be linked to the fatal tryptophan disaster of 1989 (see my article L-Tryptophan: The Truth About The FDA Tryptophan Recall Of 1989).
David J. Graham, MD, who worked as a FDA official overseeing drug safety for 20 years, revealed how his FDA superiors tried to muzzle him over his sound evidence that showed Vioxx, a painkiller marketed as exceedingly safe and effective, was very dangerous because it increased the risk of heart attacks . Graham further disclosed that the FDA higher-ups had discredited, intimidated and harassed him, and that the FDA managers wanted him to falsify his troubling findings on Vioxx by having him change his conclusion and interpretation of what he had found [14,37].
"In a scientific organization, especially one dealing with patients' health and lives, there should be no (zero) examples of suppression and intimidation of its scientists. [...]. Yet [...] FDA has a well-established history of suppressing its scientists [...]." 
"What has emerged is a lethal triangle involving FDA, the pharmaceutical industry and Congress."  [emphasis added]
Therefore, the dismal situation described in the letter of 2009  has been the prominent reality throughout the (recent) FDA history.
The letter was unsigned presumably because of the scientists' fear of losing their jobs, and being subjected to other repercussions. After all, in the letter the scientists disclosed that:
“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal.”
Similarly, a survey of FDA scientists in 2006  found that:
Instead of fixing the profound problems gnawing at the FDA's core, the government agency reacted with more elaborate repressive measures (to conceal deep FDA corruption) not long after the release of the revealing 2009 letter of the dissenting scientists.
In 2012 a New York Times piece reported of a massive FDA surveillance operation targeting some of its own scientists, intended to stop the potential public exposure of criticism about the agency's medical product review procedure .
All of this robust evidence is irrefutable proof of "institutional corruption"  regarding the societal mission of the FDA, evidence that something is terribly wrong with this public health department. Namely...
As David J. Graham, MD, explained:
"FDA is inherently biased in favor of the pharmaceutical industry. It views [the medical-pharmaceutical] industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed"  [explanation added]
The plain hard fact is this:
... bear any accuracy and significance.
A big red flag flaunts when the widely disseminated allegations made for tougher supplement regulation are baseless and untrue. The query then becomes what the true motive is behind the enduring crusade by the dominant medical culture for better vitamin regulation...
"The whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, all of them imaginary." (H. L. Mencken, 1880-1956, Journalist & Social Critic)
The US government (FDA) grants you free access to, and the right to, obtain cigarettes and other tobacco products (and prescription medications/over-the-counter drugs), which harm and kill hundreds of thousands of people every single year, but in their long "war on supplements" they actively pursue bogus avenues ("imaginary hobgoblins" per Mencken's abovementioned quote) to restrict the free availability of dietary supplements which are extraordinarily safe in comparison.
An observation made by the physiologist Ray Peat, PhD, about the reason why certain people in science get attacked, suppressed, and silenced (similar to attacks against nutritional supplement proponents in the healthcare sphere) even though they may speak the truth and did nothing wrong, appears to neatly fit and describe the illogical behavior of the FDA against vitamins and minerals:
“In the community of science it is the same way as who gets invaded [by the military]. It isn't a matter of who is doing something objectively, it's who is hurting whose interests.”  [explanation & emphasis added]
In the coercive world of the FDA (and other government health branches) making decisions based on reality ("the real world") doesn't have precedence over guarding corporate interests which the agency is part of via its incestuous alliance with the medical-pharmaceutical industry [23,34,52].
As described earlier, it is commonplace for having “advisers” with ties to the drug cartel consulting the FDA on drug approvals, which guarantees for drug-friendly polices, or, respectively, assures the oppression and censoring of anything that could threaten the profits of the pharmaceutical companies, such as "alternative" modalities of healing (like vitamin therapy).
Oppression and suppression, that's what's really behind the unreasonable deceptive pleas for firmer drug-like supplement regulation.
For instance, some proponents of nutritional supplements have been accusing another widely respected US government agency, the National Institutes of Health (NIH), of selectively omitting (which suggests intent) substantial and scientifically solid pro-supplement research data in an evaluation of the effectiveness and safety of these products .
The NIH review actually found little hard evidence that supplements are unsafe (even from a supposedly biased selection of scientific papers) but nevertheless concluded safe supplements should be more regulated by the FDA .
Yet the supplement advocators raised a useful question:
"Why would NIH push so hard for FDA control of vitamin supplements, which are safe, when FDA clearly is not effectively controlling pharmaceutical drugs, which are dangerous?" 
Nonetheless, the NIH has been pushing for this scheme in more than one way, regardless of what the real-world reality is. Under the guise of one of its splinter outlets, the NCCAM (National Center for Complementary and Alternative Medicine), that purports to support non-orthodox, alternative medical approaches, it has focused on getting the producers of health supplements to improve their manufacturing and product quality standards:
“[...] NCCAM has approached dietary supplements with the aim of steering as many as possible toward the FDA’s drug approval process and its benefits of premarket approval and more accountable manufacturing.” 
Considering the ineptitude and irrationality of the NIH (and its "office of dietary supplements" [ODS]), and that it had been declared that the submission of the NCCAM under the rubric of the NIH was "a situation set up to fail" , it is no surprise the NCCAM has been accused of being a wolf in sheep’s clothing (akin to the FDA), ultimately obeying the mandates of the medical-pharmaceutical syndicate .
Another "forgotten" or hidden "shadow" of the established medical culture is that the FDA and Western medicine (and their supporters) have a rather long history of hounding and/or eradicating a relatively minor health risk, as in the case of dietary supplements, or other genuinely beneficial modalities of natural medicine (such as alternative cancer therapies)[1,29,30,42,57,58,68,71,72,76].
It is indicative the real intent for stricter supplement regulation is shrouded in politics (or complete ignorance, or denial), rather than a sincere concern for the health interests of the public.
(Other US government committees, such as the National Cancer Institute (NCI), and heralded alleged non-profit charity organizations, such as the American Cancer Society (ACS) -"the world's largest nonreligious "charity"" - have also engaged in the witch-hunt of alternative healing therapies [74,75]. For more on the highly mainstream medicine-favorable, corrupted ACS read the afterword in my article A Mammogram Letter The British Medical Journal Censored on The Unholy "War On Cancer").
Alternative or natural medicine, also known as the wellness industry (which includes the dietary supplement industry), is hurting the interests of the medical-pharmaceutical industry by means of (increasingly) infringing on, and digging into, its profits and by implicitly revealing that the conventional medical methods are inadequate [58,59].
The FDA, as the gatekeeper, police force, and profiteer of this syndicate of organized money [34,52,57,58,60,69], is therefore perpetually throwing phony obstacles and accusations ("imaginary hobgoblins") in the path of the health industry, going on for decades, trying to curtail their prominence and status as with unjust supplement regulation [1,58,61].
Best-selling author Hunter Lewis announced in blunt language that:
"[...] the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the Agency’s bills." 
In a report of 1993, the FDA itself practically admitted to striving to curb nutritional supplements because of their competition with pharmaceutical drugs .
The backbone of orthodox medicine, the American Medical Association (AMA), has also been found to admit to its efforts to get rid of competitors . And in 1987, a federal judge ruled that the "AMA and its members" were in violation of monopoly laws, having "participated in a conspiracy against chiropractors" , because the business cartel had engaged in "systematic, long-term wrong-doing" against the medical modality of chiropractic "with the long-term intent to destroy a licensed profession" .
The tactic of choice for the totalitarian medical establishment to accomplish its nefarious objective of wiping out valid competitors such as nutritional supplement manufacturers and vendors is "to keep the populace alarmed" (Mencken) about alleged dietary supplement risks.
Often, the resort to this fear-mongering technique is driven and manifested by another closely related motive.
Namely, in order to avoid culpability and to reduce widespread public awareness about the truthful horrific realities of "well-meaning" consensus medicine (made possible by "objective" "tight" federal regulation of their products and devices), the official medical cabal and their allied corporate mass media engage in sophisticated (or "science-based"?) acts of truth-denial, as in the misleading distraction of the public's attention away from the actual horrendous reality about the traditional medical industrial complex (e.g., the fact that it's a major cause of death and injury) by getting the public very concerned and frightened about the "big" dangers of supplements (due to "light" supplement regulation).
The overall tactic is the ancient disingenuous play on human fear, arguably one of the most beloved and applied propaganda tools of authoritarian institutions and regimes all across the globe, because it effectively allows for the control of people's behavior and cognitive orientation. Ultimately, it's manipulation. It's the manipulation of people's perception. It's the manipulation of the truth.
A specific example of this type of mental manipulation of the public mind -that is, the use of the fear-technique characterized as "to keep the populace alarmed"- is the promotion of sensationalistic, misleading medical headlines and pseudo-facts, like "too much vitamins or too much supplements are bad for your health", apparently hoping, or betting on, the unsuspecting public doesn't realize that "too many" or "too much" of any edible substance, even water, is harmful to your health.
Some people have slashed through this trivial propaganda:
"[...] instead of drug companies saying they don't want supplements to compete with their toxic drugs, supplements are being labeled dangerous and should be banned! But, I guarantee you will see these supplements return soon enough when drug companies figure out how to patent them, make them prescription items and charge exorbitant fees for them." (Carolyn Dean, MD, ND, in 2013)
Others admonished that:
“If the public can be frightened into thinking dietary supplements are dangerous, a bought-off Congress, along with popular news anchors and authors like Dan Hurley, could orchestrate a groundswell of public opinion to designate dietary supplements as ”drugs”." 
Here's another example of the spurious workings of the public health officialdom in regard to existing supplement regulation...
The public health department and the drug industry-sponsored American mass media keep reminding the public about the poor compliance of many makers of food supplements in regard to FDA guidelines on manufacturing policies (=the cGMP regulations of 2007), and about a prevalence of misleading and illegal product advertisements amongst promoters of vitamin and mineral supplements.
According to a study released in 2011 :
Since medical drugs cause many times more serious damage than vitamin supplements, shouldn't the dissemination about, and “clean up” of, false and misleading marketing by pharmaceutical medicine be a priority over the same or similar issue of the supplement industry?
Heeding reality-based facts, a medical scientist drew the politically impolite but firm conclusion that "Drug regulation needs a revolution" .
"Failing to consider that the game is rigged in favor of the house is why the “solutions” always make things worse." (Ray Peat, PhD, Biologist, in 2013) [emphasis added]
The DSHEA of 1994 (and, to a lesser degree, the cGMP regulations of 2007) gave the public free access to food supplements.
The consequences of having FDA approved vitamin supplements would be that:
reducing the public' unrestricted access (=freedom) to these all around extremely safe products, flanked with a large body of strong evidence of impressive vitamin benefits and supplement efficacy (see 2 Big Lies: No Vitamin Benefits & Supplements Are Very Dangerous).
Some of these negative or sub-optimal effects for public health have already been in existence for quite some time. Many popular nutritional supplement brands are owned, manufactured, and marketed by pharmaceutical companies. Yet the ingredient formulations of these products are commonly poorly designed accounting for largely ineffective or minimally effective (=RDA-based) food supplements.
Presumably, this is because the drug industry doesn't want their own (cheap) supplements to interfere with their much more lucrative, main business: treating disease long-term with expensive medications.
Currently much less frequent goods in the marketplace are highly overpriced pharma supplements such as Lovaza, a FDA-approved fish oil supplement made by a large drug company. Outrageously costly health supplements were to conceivably gain a more prominent status upon the implementation of some sort of so-called science-based medicine supplement regulation that calls for the products' manufacturers to get FDA approval akin to pharmaceutical companies with their prescription drugs.
If stronger supplement regulation were to come to pass, whereby the FDA would test and approve the products, you can likely count on that, eventually, most (or all) vitamins will be either cheap and barely useful, or exceedingly overpriced (although the health insurance would probably pay for it, driving up health care costs).
At the end, the effect is this: public health on the whole will not benefit as people will either buy predominantly non-beneficial/minimally effective products or won't take any as most regular doctors are poorly educated about these products and thus won't prescribe them to patients as a matter of routine, instead the physicians focus on preferentially prescribing medications.
As far as stricter supplement regulation and FDA product approval goes...
The evidence of the real world is such that the allegedly firm product testing system of the FDA, resulting in over a hundred thousand deaths every year from the correct use of prescription drugs, should be changed, improved, or preferably replaced, immediately (and run by a truly independent organization and regulatory consultants, i.e., free of conflicts of interest [24,35]), rather than make modifications to a weak framework of supplement regulation (such as the meme for FDA approved supplements), allowing for exceptionally few deaths every year.
Alexander Schauss, PhD, poignantly revealed the hypocrisy and the involvement of politics behind the motivations of the purported medical elite when he said:
“Where are the bodies that should compel the supplement industry to spend hundreds of millions of dollars on human studies to prove the safety of its products to the satisfaction of the FDA or its critics?” 
I wonder what kind of “evidence” the people are looking at who strongly demand FDA safety and efficacy verification for vitamins, people who frequently love to cloak and associate themselves with the title of evidence-based thinkers, skeptics, and reasonable people with common sense, to come up with such an unbalanced and distorted assessment of the genuine facts?
It's utterly ironic. But actually... it is a sad and terrifying situation. Because in the end, safety and effectiveness, whether it is related to drugs or supplements, is about people. The health and lives of people.
What the gigantic number of human fatalities (and other serious injuries), caused by the proper use of FDA-sanctioned pharmaceutical drugs, documents is this:
Any way you look at it, actual reality is not in support of the official claims made by the mainstream medical cabal about the safety and effectiveness of pharmaceutical drugs and the scientific reliability of government regulation and approval of drugs via its review process.
Also, since the FDA routinely approves extremely harmful or non-beneficial (=worthless or useless) pharmaceutical medications is it far-fetched or implausible to assume or expect this government body also signs off on and certifies other very damaging or "snake oil" merchandise and procedures of mainstream medicine by way of its medical device approval process?
No, not if you acknowledge and follow, instead of overlook and deny, the objective evidence.
In 1992, James P. Carter, MD, commentated in a book that the medical orthodoxy is swift to disparage natural healing therapies as "unproven" (while glorifying their own traditional methods) yet:
"[...] about 80% of all medical procedures now used in the daily practice of medicine have never been "proven" through [double-blind controlled] research studies. Organized Medicine never complains about that."  [explanation added]
In 2007, longtime deputy editor of both the JAMA and the NEJM, Drummond Rennie, MD, mentioned in a paper investigative data that showed the FDA had approved a medical device known to be neither safe nor effective . Award-winning writer John Carey reported in 2006 about various FDA-approved traditional medical treatments and procedures that don't work well, contrary to the medical establishment's soaring health claims about them .
The majority of marketing claims and statements made by the mainstream medical business about their products and interventions in terms of risks or benefits cannot be substantiated with any relevant scientific data in the medical literature [23,32,45,83,84,85].
(By the way, that long list of therapeutic blunders includes top-selling prescription medications in the world, such as statin drugs -more on the real scientific value of statins is in my article "Do Garcinia Cambogia Side Effects Boost Diabetes?" [direct link to it at the end of this article under Recommended next pages].)
Medical researcher, Peter Gøtzsche, MD, documented in his 2013 book release the generally poor (and biased) scientific evidence in favor of psychotropic drugs (antipsychotics and antidepressants) . In fact, Gøtzsche concluded that the availability and typical use of these psychiatric drugs create "more harm than good" .
I had written extensively about one popular medical procedure, screening with mammography, demonstrating that the famous breast exam causes more harm than good for the overwhelming majority of women (see my ebook "The Mammogram Myth"). After all, the basic -biased and faulty- configuration the official endorsement of mammography rests on, is exactly the same as with (many) FDA-cleared prescription drugs, as illuminated by the senior FDA official David J. Graham, MD:
"FDA consistently overrated the benefits of the drugs it approved and rejected, downplayed, or ignored the safety problems that ultimately led to their withdrawal."  [emphasis added]
Yet, much of the American public believes ardently and uncritically, akin to young children, in the authority and authoritative claims of the boogeyman, meaning the public health authorities and organized medicine (the allopathic medical profession), confirmed by the large percentage of people who routinely take prescription medications and regularly subject themselves to other modalities of standard medicine. As Berman denoted, "Every civilization believes in its own propaganda."
Not so long ago the hapless public had to be taught organized religion (the church) had hijacked and dominated the governmental officialdom to advance the private interests of the pious conglomerate, before a move to separate religion from state was taken into consideration. Now, much of the public needs to recognize that we're (still) back in the old days (the Middle Ages?) as today organized money -that is, big multinational corporate industries- control and command the federal leadership for mostly their private interests.
The crucial aspect of the "rigorous" government product authentication process for safety and efficacy is obviously the formal appearance of operating under such stringent policies even if these ordinances are largely meaningless in a civilization ruled by deep cronyism (=favoritism) between government and the medical industry [1,23,52,58,71] and a widespread lack of integrity in medical research [23,35,45,58,66].
In a nation ruled by corporatism (i.e., crony capitalism), seemingly persuasive authoritative claims (e.g., "fully tested for safety and efficacy by the stringent approval system of the FDA" or "only products that are safe and effective [per the FDA's full review process] will be permitted to be sold"), divulged by reigning pillars of high influence, attain greater significance than the real world (=the actual facts).
Therefore, no logical well-founded reason exists anywhere in favor of stricter supplement regulation, to have vitamin supplements “evaluated” and “approved” (as drugs) by a completely rigged FDA testing program and agency [1,23], a drug industry-sponsored conglomerate which is "unanswerable to the American people" (Emord).
There is no real, logical NEED for stricter supplement regulation but there is a real, illogical WANT for it.
The backing and support of a motion advocating a formal tightening of dietary supplement regulations, under the official pretense "to protect the public", is self-defeating to the public...
... AS LONG AS THE FEDERAL REGULATORS OF THESE PRODUCTS ARE THOROUGHLY CORRUPTED BY CORPORATE AGENDAS...
... representing primarily big private, instead of public, interests.
Apparently, Benjamin Franklin (1706-1790), printer, scientist, inventor, statesman, author, and one of the "Founding Fathers of the United States", may have been quite aware of the tremendous danger of misguiding political pretexts (not unlike the one surrounding the motion for firmer supplement regulation in more current times) when he remarked:
"Those who would give up essential Liberty, to purchase a little temporary Safety, deserve neither Liberty nor Safety." 
In other words...
For the sake of your own best health interests, don't fall for this campaign (=act of deception) -that is, nutritional supplement regulation by the FDA- as long as the foxes (i.e., the medical-pharmaceutical-federal industry complex) guard the henhouse (i.e., the vitamin industry).
And expect that this core setting surrounding the arena of supplement regulation will not change anytime soon, continuing to leave the vitamin world vulnerable to ample demonization (with "imaginary hobgoblins") and a decisive turn to the worse.
Don't believe it? Just look at the real history of the FDA and organized medicine.
(Originally published: Dec-2013 | This is an updated version)
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