The laws of dietary supplement regulation allow you to have free access to nutritional supplements. This is a blessing. A triumph the public fought hard for. And continues to fight for.
But you are paying a heavy price for the unrestricted access to vitamins and supplements.
The realm of food supplement regulation is hallmarked by legislative loopholes, pitfalls, and has significant restrictions in regard to product health claims. To say it differently, it is a weak set of dietary supplement regulations.
This leads to a market saturated with products of poor supplement quality.
For example, there is virtually a total lack of comprehensive, stringent rules ensuring that nutritional supplement manufacturers make products of only high quality. Meaning that the vitamins and health supplements are safe, effective, and science-based.
In other words, one of the core facts about vitamins is that the legal environment of dietary supplement regulation is such that there is an absence of guarantee that the supplements deliver benefits, that they actually and substantially improve your health.
The official authorities, such as the FDA (the US Food And Drug Administration), do not analyze, test, or approve nutritional supplements for safety and effectiveness. There's no official process or procedure that tests nutritional supplements for authenticity. You will not find FDA approved supplements, or government assayed nutritional supplements, anywhere.
Take it from the horse's mouth:
“Dietary supplements are not approved by the government for safety and effectiveness before they are marketed.” (Official US Government FDA website, accessed Oct. 2011)
The nutritional supplement manufacturers (or suppliers) are responsible, virtually exclusively, for the quality of nutritional supplements. That is, whether a product is safe, contains exactly what is on the label, and whether it actually works.
And to make matters worse...
There is a lack of dietary supplement enforcement. The FDA does not have the resources to adequately and efficiently impose nutritional supplement guidelines.
This, in turn...
... enables, and even encourages, the manufacturing of nutritional supplements compromised in quality. For instance, frequently food supplements are not true to label claims. That is, the products don't contain what is stated on the label:
“In recent years, analyses of dietary supplements by a private sector laboratory suggest that a substantial number of dietary supplement products analyzed may not contain the amounts of dietary ingredients that would be expected to be found based on their product labels. (“FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements”, March 11, 2003; from Official US Government FDA website, accessed Nov. 2010)
Bruce Silverglade, from the Center for Science in the Public Interest (CSPI), most eloquently, and accurately, described the outcome of a “marriage” between weak regulatory laws and a lack of dietary supplement enforcement...
"When it comes to dietary supplements, it's like the Wild West, and the bad guys know they don't have to take the sheriff seriously." (CSPI, 2009)
The end result of all this?
Quite possibly an uncomfortable realization regarding your much valued health and nutritional supplements...
Are you ready for this?
You do have unrestricted, free access... to mostly low-quality, ineffective discount vitamins and nutritional supplements.
Indeed, an evaluation and comparison of over 1,600 health supplements revealed that the vast majority of products are of low or mediocre quality (MacWilliam, 2007 & 2011).
Pieter Cohen, MD, a researcher from Harvard Medical School, who is very familiar with quality issues in the nutritional supplement industry stated that the weak legislative framework of FDA dietary supplement regulation leads to the...
“[...] domination of the market by low-quality products […].” (Carvajal, 2010)
Therefore, and most importantly for you to comprehend and be fully aware of...
It is very likely that you, at this
very moment, take (or end up taking) nutritional supplements that are ineffective.
A different way of looking at the world of FDA dietary supplement regulation, another conclusion to draw from the regulatory framework on food supplements is...
You cannot rely on the official authorities (the government) and the existing legislative arena of dietary supplement regulation to give you a guarantee on supplement quality (safety and effectiveness) about any product available on the market.
Rather than counting on the public health officials the focus to assure the quality of nutritional supplements needs to be elsewhere.
As pointed out, for confidence in the quality of supplements you have to rely entirely on the nutritional supplement manufacturers (or suppliers), as the ruling authorities on dietary supplement regulation had indicated.
Because the marketplace is flooded with low-quality, ineffective discount vitamins and nutritional supplements this suggests it is in your best interest to choose products from dependable dietary supplement manufacturers, or nutritional supplement companies.
From supplement makers who are fully committed to creating only high-quality, safe and effective nutritional supplements.
Dedicated to first value your health, before their own profits.
This, in a nutshell, is the quintessential reality of the currently existing world of dietary supplement regulation.
As far as dietary supplements and regulations concern, the first legislative set of policies was the Federal Food, Drug, and Cosmetic Act (FFDCA or FD&C) of 1938. It replaced the first regulatory framework which addressed the safety of food, drugs, and folk remedies (or patent medicines), the Pure Food and Drug Act of 1906.
The FD&C primarily covers issues of safety, purity (and to a lesser extend, effectiveness), and labeling of foods, drugs, and cosmetics (California And Western Medicine, 1938).
Importantly, the FD&C act, quite significantly, expanded and increased the regulatory power of the FDA, the first official consumer protection agency of the US government. For instance, the FD&C gave the FDA much more authority to render penalties to violators of these regulatory policies (California And Western Medicine, 1938).
There are regulatory guidelines drafted exclusively for prescription medications and over-the-counter drugs. Dietary supplements are regarded and classified as foods. Those substances encompass a separate category, with different policies.
Note that the rules that regulate pharmaceutical drugs and over-the-counter medications are much more stringent than the policies for dietary supplement regulation and the guidelines for foods (Gibson & Taylor, 2005).
Ever since nutritional supplements began popping up and became more and more popular in the 1940s and 1950s, the FDA tried at several occasions to regulate dietary supplements as unapproved drugs (Gibson & Taylor, 2005; Brownie, 2005), rather than food items.
A victory in this endeavor would have put the FDA in a position of tremendous power.
It would have enabled them to severely restrict public access to these natural health products, since drugs require a doctor's prescription.
Fortunately, the agency never succeeded in that mission, largely because of public outcry and campaigns against these oppressive efforts by the FDA (Brownie, 2005).
Author and long-time health writer, Frank Murray, stated in an interview:
“At the core of FDA’s approach was that, if a vitamin or mineral exceeded the RDA [=recommended daily allowance], it would be declared a drug, and you would need a prescription to buy the supplements at a pharmacy. The FDA also suggested that supplements exceeding 50% of the RDA would be declared a drug. The FDA also attempted to curtail the sale of vitamins A and D over the counter, claiming that megadoses were dangerous.” (Passwater, July 2005)
A landmark battle was won against the
FDA's intentions to restrict the consumers' free access to supplements
with the vitamin Act of 1976. Sometimes fondly referred to as “the
Proxmire Bill”, after senator William Proxmire (Passwater, July 2005).
This legislative policy on dietary supplement regulation assured that
supplements continued to be treated as foods and not drugs, thereby they
did not require a prescription from a doctor (Passwater, July 2005). And the “Vitamin-Mineral Amendment” of 1976 stopped the FDA from limiting the potency of vitamin and mineral supplements (Van Breemen, 2018).
The unrestricted access to supplements was extended a few years later, in 1994, with the Dietary Supplement Health and Education Act (Public Law 103-417), also known as DSHEA. The DSHEA is overseen by the FDA.
Up until the introduction of the currently valid core policies of dietary supplement regulation, the DSHEA of 1994, nutritional supplements were classified as food items. With the introduction of the DSHEA dietary supplements received a slight but significant “upgrade” in status. They became a separate subdivision within the food category:
“[...] DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs […].” (Official US Government FDA website, accessed Oct. 2010)
“That regime [DSHEA], while closely related to the regime for food, was not identical to the food regime.” (Official US Government FDA website, accessed April 2011) [explanation added]
The new subsection made food supplements appear more guarded, or shielded, against a re-classification to drug status by the regulatory establishment, the FDA.
The DSHEA is supposed to guarantee people the free access to a wide selection of dietary supplements, and to provide consumers with more truthful information about supplements, such as what they are intended for (Dickinson, 2010). (This is addressed with the DSHEA regulations of dietary supplements and health claims, covering three types of approved supplement claims.)
In addition, the DSHEA gave the FDA the authority to “remove from the market products the agency deems unsafe” (CRN, 2011).
The attempts by the FDA to re-classify nutritional supplements as drugs, to restrict access to health supplements, and to block and suppress pertinent, scientifically sound information about vitamin benefits continue to this day.
One of the more recent of such schemes was the dietary supplement safety act of 2003. It was geared towards undermining the DSHEA.
The dietary supplement safety act would have given the FDA the authority and power to ban any vitamins and supplements it wants in a less controversial, swifter way than DSHEA policies currently are allowing them to do.
After significant public opposition the FDA withdrew the infamous 2003 dietary supplement safety act.
In 2011 the FDA released the new dietary ingredient (NDI) draft guidance, the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (Official US Government FDA website, accessed Oct. 2011). Once again, it relates to safety parameters of nutritional supplements. If it were to become a binding, enforceable law it would expand the scope on the definition of what a “new dietary ingredient” is.
The NDI drew criticism from consumer protection groups, such as the The Alliance for Natural Health USA:
“FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI notification. In other words, only supplements on the market before October 1986 could be considered “safe.” This is patently ridiculous, since the cutoff date for grandfathered ingredients assumed to be safe, according to DSHEA, is October 1994.” (ANH-USA, 2011) [emphasis added]
If this guidance draft were to become legally binding it, potentially, would put a number of currently available “non-new” supplement ingredients into the regulatory arena of the revised “new dietary ingredient” law, making many current products containing these substances immediately unlawful. Because the FDA could deem these supplements “adulterated”. The result? A removal of tens of thousands of food supplements currently on the market (ANH-USA, 2011).
Since the introduction of the most current set of dietary supplement regulation, the DSHEA of 1994, many new manufacturing practices have developed. Different extraction methods, the use of new solvents, and other novel ways of processing supplement nutrients.
The FDA's NDI guidance draft addresses the concern whether these new manufacturing methods alter the chemical structure, or composition, of a supplement ingredient in a way whereby it poses a safety issue for consumers.
Undoubtedly, changing the chemical make-up of a substance can alter its effects, from beneficial to toxic, or the reverse.
However, what is the evidence that the new manufacturing processes created harmful supplement ingredients? What does the reality of user experience look like?
Apparently, the new manufacturing methods haven't created (many) toxic ingredients, if any at all, since the introduction of the DSHEA in 1994.
The extent of harm or deaths due to supplement consumption has remained virtually unchanged (American Association of Poison Control Centers, 1983-2008; Bronstein, et al., 2010).
In other words, the FDA safety concern seems largely a... non-issue.
Why would the FDA, with its lack of resources (staff and funds) for adequate dietary supplement enforcement, at a time period of severe economic recession, focus on safety aspects of vitamins and health supplements when these products, overall, have a stellar history of documented safety during the numerous years since the DSHEA became the official set of policies of dietary supplement regulation?
The Alliance for Natural Health USA, a non-profit organization dedicated to promote “freedom of choice in health care”, pointed out:
“The very reason pre-DSHEA supplements were grandfathered is because they had proven themselves safe through years of use by hundreds of thousands of consumers! If safety is of utmost concern to FDA, why does the guidance document burden the supplement industry with regulatory requirements that have nothing to do with proving the safety of the supplements? It appears FDA is acting out of spite—and not in the public’s best interest.” (ANH-USA, 2011) [emphasis added]
Jonathan W. Emord, Esq., a lawyer who's very familiar with FDA laws, put forward an answer as to why the FDA pounces on dietary supplement safety, an issue largely devoid of substance...
“The determination to issue the guidance is a political one. […]. The problem with this initiative is that politics have prevailed over science and common sense.” (Watson, 2011) [emphasis added]
In late April of 2012 while still a draft, thus not legally binding, The Alliance for Natural Health USA pointed out that the FDA began to enforce a provision of the NDI (FDA, April 27, 2012) before the release of its final guidance and contrary to what they apparently had promised to advocacy groups from the nutritional supplement industry (ANH-USA, May 2012). Enforcing a draft, which is not part of the DSHEA, is in violation of US law (ANH-USA, May 2012).
After much public and industry opposition, and somewhat unexpectedly, the FDA announced that it considers revising the NDI draft which the government agency had adamantly defended (ANH-USA, 20-June-2012).
The FDA has a rather long history of playing politics. Predominantly because of self-serving interests (conflicts of interests).
The pharmaceutical industry's tentacles of influence and power stretch far into every direction. Profoundly affecting medical research, the media, and even the government and its legislative agencies.
For instance, the FDA is practically an employee -the police force, to be exact- of the pharmaceutical industry because drug companies fund a large chunk of the payroll of the FDA (Angell, 2007; HHS/FDA, 2009).
In an article the constitutional attorney Jonathan W. Emord, Esq. revealed:
“Based on the testimony and correspondence of more than a dozen FDA medical reviewers turned whistleblowers, the agency is a captive of its principal regulatee, the pharmaceutical industry, [...].” (Emord, Nov. 2010) [emphasis added]
The pharmaceutical industry employs and recruits several hundred lobbyists to defend their bottom line, and enforce their agenda of financial growth, at the highest legislative level -the US government (Aaron & Lincoln, 2003; Angell, 2004).
Dependable consumer advocate and former presidential candidate, Ralph Nader, stated in an interview:
“If you take departments of commerce, interior, agriculture, treasury, food and drug administration [=FDA], 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.” (Mantel & Skrovan, 2006) [emphasis & explanation added]
For consumers, unfortunately, the tight symbiotic bond between government and pharmaceutical corporations represents an unfavorable, unhealthy alliance. This nefarious collaborative union strongly affects the legal framework of dietary supplement regulation, via the administrative power and influence of the FDA.
The FDA has a longstanding history of trying to suppress and restrict natural nutritional supplements (Gibson & Taylor, 2005; Brownie, 2005).
Nutritional supplements are competitors of pharmaceutical drugs. Therefore, the supplement industry infringes on, and threatens, the profits of the drug companies. They call upon the FDA to “step in” and rectify the situation...
Devastating conflicts-of-interests are at the bottom of the supplement politics played by the FDA (Emord, 2008 & 2010). [For more on FDA politics and the agency's seriously compromised position in its duty and responsibility to public health see my piece Tougher Supplement Regulation: A Necessity Or Politics?]
The FDA (in direct collaboration with the drug companies) keeps claiming, falsely, that nutritional supplements are a significant safety thread for consumers.
More than once the FDA released inaccurate data about the safety of vitamins and supplements. And even after several vigilant researchers had made the federal agency aware of the blatant errors the FDA continued to keep the incorrect information public for many years, without correcting their mistakes or publishing a disclaimer (Passwater, 1991; Schauss, 2007).
These are nothing but deceptive, malicious actions.
The FDA continues to misrepresent the facts about dietary supplements and risks -especially safety aspects thereof.
Consequently, the FDA argues that supplements ought to be deemed drugs, which would put them under the control of the FDA (the drug companies in reality).
Of course, this would result in heavily restricted access to vitamins and health supplements. Because then supplements would be classified as drugs. Only with a doctor's prescription could you get a drug. Not any longer could you just walk into a health food store and buy dietary supplements.
In addition, the re-classification of nutritional supplements to drugs would almost certainly lead to the removal of many such products from the marketplace. After all, these products are directly competing with pharmaceutical medications.
This is the angle the FDA and its corporate allies among the medical establishment have attempted to manipulate and submerge the DSHEA, and other legislative references of dietary supplement regulation prior to it.
“[...] a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.” (John F. Kennedy, 1917–1963, Former US President)
Above and beyond, however...
The intention of the authoritarian establishment, by way of implementing bogus fraudulent restrictions on nutritional supplements, is an attack on your freedom.
Your freedom to choose. Freely.
(Originally published: ca. July-2012 | This is an updated version)
(This article is PART 1 of a comprehensive guide to “Exploring The Shady World Of Dietary Supplement Regulation”)
Recommended next page(s):
The Shady World Of Dietary
Supplement Regulation" (3-Part Article)
You are here: Nutritional Supplements HOME › Dietary Supplement Regulation (PART 1)