The Core Rules Of Dietary Supplement Regulation

Riddled With Drawbacks

The policies of dietary supplement regulation, the DSHEA of 1994, are infiltrated with loopholes, pitfalls, and restrictions. Thereby, they fail to provide you with a solid reassurance about the quality of nutritional supplements -particularly in regards to supplement efficacy.

The DSHEA is a relatively lax set of regulatory mandates. For instance, the FDA does not analyze or test health supplements. There are no FDA approvals for supplements. There are no government certified nutritional supplements.

Bottom line?

Whether a food supplement is safe or effective is entirely up to the nutritional supplement manufacturers.

On top of that, certain confusing restrictions about dietary supplements and health claims prevent anyone from expressing the full extent of health benefits attainable with food supplements.

In brief...

Certain rules prohibit the publication of the whole truth on nutritional supplements.

What are the consequences of these legislative drawbacks?

A marketplace saturated with cheap, inadequate vitamins and health supplements.

And...

Many consumers of nutritional supplements either don't know or will not recognize what a high-quality, science-based, truly effective dietary supplement is. Or, they are not even aware of the existence of pure vitamins, of effective high potency multi vitamins, because they are accustomed to the widely advertised, scientifically-compromised (seriously ineffective) "one a day vitamins" and other (mostly) cheap supplements.



Main Guidelines Of The DSHEA:

-Weak Rules Make For A Market Flooded With Low-quality, Ineffective Discount Vitamins And Nutritional Supplements

Among the many guidelines of dietary supplement regulation (DSHEA) are:

  • In order to use and advertise any new substance, nutrient, or ingredient not marketed before the 1994 DSHEA came into existence, the manufacturers or distributors of such ingredients are responsible to notify the FDA and provide safety data on the new nutrient prior to marketing it.
  • The term “dietary supplement” must be mentioned somewhere on a product label.
  • The Federal Trade Commission (FTC), not the FDA, is in charge to oversee the advertising of nutritional supplements.

However, some of DSHEA's most significant food supplement regulations are entangled in pitfalls, loopholes, and restrictions. Following is an outline of some of the central rules of dietary supplement regulation (per Official US Government FDA website, accessed between 2010-2012), and the weaknesses of these edicts.



Dietary Supplement Regulation Pitfall & Loophole...

-The Quality Of Supplements Is “Solely” Up To Nutritional Supplement Manufacturers

The US government itself pointed this out very clearly:

“The responsibility for ensuring the validity of the product claims rests solely with the manufacturer.” (US National Library of Medicine, March 2011) [emphasis added]

This means that...

  • The manufacturers of dietary supplements are responsible for the safety and efficacy of their products before they put them out on the market.
  • Per the specifics of FDA dietary supplement regulation, no clinical trials or scientific studies are required of supplement manufacturers to verify the safety and efficacy of a supplement (just like with most food items).
  • The nutritional supplement manufacturers (or suppliers) are required to make sure product label are truthful and not misleading.

In other words, according to some of the central decrees of dietary supplement regulation, pre-market quality approval of nutritional supplements is rendered by the very people who make, sell, or distribute them.



Dietary Supplement Regulation Pitfall & Loophole...

-No FDA Approvals For Supplements And Nutritional Supplement Manufacturers

“A 2002 FDA-sponsored health and diet survey [...] estimated that a majority of respondents who used vitamin or mineral supplements believed that the government approves dietary supplement products before they are marketed to consumers.” (GAO, 2009)

Some core facts about vitamins are that...

  • The FDA does not test supplements:
  • “The agency does not analyze dietary supplements before they are sold to consumers.” (Official US Government FDA website, accessed Sept. 2010)

    Tested FDA approved vitamin supplements do not exist.

    Nevertheless, in accordance with rules of dietary supplement regulation, manufacturers of supplements need to have data available confirming that their products are safe and effective. A study found, however, that usually this information is absent (Hass & Lewis, 2006).

    Moreover, by law, the dietary supplement manufactures don't even have to make such pertinent information available to you, the consumer. No wonder then that few nutritional supplement companies ever make such data accessible to the public.

  • There are no FDA approvals (of safety
    and effectiveness) for supplements:
  • “[...] dietary supplements do not need approval from FDA before they are marketed.” (Official US Government FDA website, accessed Sept. 2010).

    In other words, there are no FDA approved supplements, no officially assayed nutritional supplements on the market. And no official regulatory procedure that analyzes and tests nutritional supplements for authenticity exists.

    Interestingly, before 1994 herbal products, for example, were considered “food additives” and their nutritional supplement manufacturers were required to provide proof of safety before they could be marketed (Larsen & Berry, 2003; Cohen, 2009). The DSHEA of 1994, in actually, weakened the quality standards for supplements, making the arena of dietary supplement regulation a supplement-industry-friendly set of policies:

    “The marketing of dietary supplements in the USA has been essentially deregulated by the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).” (Nesheim, 1999)

    It prompted The New York Times to refer to the DSHEA as “The 1993 Snake Oil Protection Act” (Marcus, 2007).

    An explosive increase in the number of food supplements available on the market was the direct consequence of the passing of the DSHEA.

  • Nutritional Supplement Manufacturers Are
    Not “Approved” Or “Certified” By The FDA:
  • The legal declarations of dietary supplement regulation doe not mandate the registration of a product with the FDA. Supplement manufacturers only need to register their facility with the FDA prior to producing and marketing their products. However, no supplement facility or manufacturer is “approved” or “certified” by the FDA. In other words, there is no such thing as a FDA approved vitamin company:

    “FDA does not "approve" health care facilities, laboratories, or manufacturers. FDA does inspect product manufacturers to verify that they comply with good manufacturing practices. […]. FDA's logo should not be used to misrepresent the agency nor to suggest that FDA endorses any private organization, product, or service.” (Official US Government FDA website, accessed Oct. 2010)

    If a supplement maker qualified to produce over-the-counter medications the facility could get FDA approval. But it would be a FDA approved facility for making over-the-counter medications only, and not for making dietary supplements.



Dietary Supplement Regulation Loophole...

-Supplement Facilities Need To Be About As Clean As The Average Fast-food Restaurant

Unlike the more stringent cGMPs for pharmaceutical drugs, the regulations for food cGMPs (which closely resemble the ones for nutritional supplements) merely require that manufacturers make the supplement products in an environment that is about as clean as your average fast-food restaurant. And that they use ingredients for the products which are generally recognized as safe. To cite a government authority:

“The general food CGMPs [...] largely address practices designed to ensure that food is manufactured, processed, packed, and held under sanitary conditions and that the food is safe, clean, and wholesome.” (Official US Government FDA website, accessed Sept. 2010)



Dietary Supplement Regulation Loophole...

-No Need To Disclose The Health Risks From Dietary Supplements

Per the legal proclamations of dietary supplement regulation, there is no requirement to disclose potential safety risks of nutritional supplement ingredients mentioned on the product labels (or package inserts), as it is the case with prescription drugs. Because, as mentioned above, official FDA approvals for safety and efficacy parameters are not mandated of nutritional supplements. Information on side effects of dietary supplements, as a result, is (commonly) absent on product labels.



Dietary Supplement Regulation Pitfall...

-The Policies On Dietary Supplement Enforcement Are Reactive Rather Than Preventive

The legal setting of dietary supplement regulation authorizes the FDA to take action against these natural health products (such as removing a food supplement from the marketplace) after the product shows up on the market.

Essentially, the FDA enters the picture after problems with supplements become apparent (Jiang, 2009). Or, quoting directly from the agency's website:

“In general, FDA's role with a dietary supplement product begins after the product enters the marketplace.” (Official US Government FDA website, accessed Oct. 2010)

And...

“FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.” (Official US Government FDA website, accessed Oct. 2011)



Dietary Supplement Regulation Pitfall...

-FDA Restrictions Foster The Creation Of Ineffective Supplements

“The FDA prohibits with an absolute prior restraint every claim that a food or dietary supplement treats a disease, even if that claim is supported by scientific evidence.” (Jonathan W. Emord, Attorney, Esq., in 2011)

The laws of FDA dietary supplement regulation forbid for manufacturers, suppliers, and distributors of food supplements -and really anyone, even doctors- to make claims (explicitly or implicitly) that a supplement will “treat, cure, or prevent” a specific disease or health issue.

If permissible supplement claims are on the label they must be accompanied by a disclaimer that the product is “not intended to diagnose, treat, cure, or prevent any disease”.

So, certain specific rules of FDA dietary supplement regulation forbid anyone from potentially stating a significant portion of scientifically sound and solid evidence about a supplement product. Even if nutritional supplement manufacturers were to accurately and factually document what the products do for you, even if they were to name all the health benefits you could expect to get from the nutritional supplements based on the evidence in the scientific literature.

Ironically, the FDA itself admitted that nutritional supplements frequently deliver vital health benefits, backed up by sound scientific evidence. In a statement before a congressional hearing, Robert E. Brackett, PhD, from the FDA, testified that...

“Many Americans take some type of dietary supplement, and in many cases, there is either strong or suggestive evidence that many of these vitamins and minerals and other naturally occurring products have important health benefits.” (Brackett, 2004) [emphasis added]

Truth be told, much “strong or suggestive scientific evidence” about the benefits of health supplements is being obstructed, blocked, and made illegal to express publicly because of the policies of FDA dietary supplement regulation, whereby in few rather than in "many" cases health claims about supplement ingredients officially get approved.

One physician, Alan R. Gaby, MD, described the issue this way:

“[...] the government’s instructions to disregard the many documented benefits of nutritional supplements introduced a serious bias into the evaluation process.” (Gaby, 2003)

Essentially...

This particular repressive frawework of dietary supplement regulations neutralizes, blocks, or stops anyone from telling the whole truth about the therapeutic effects and benefits of supplements.

It suppresses vital, factual information about dietary supplements. Information that, therefore, during the “evaluation process”, will likely not get incorporated into the supplement ingredient formula. Naturally, this will more likely make for an ineffective, low-quality product.

Which means...

No benefits for your health. Or only small, minimal, or -at best- moderate benefits.



Another Critical Pitfall & Loophole...

-A Weak Legislative Framework Of Dietary Supplement Regulation Breeds Misconduct And Fraudulent Activities

Fundamentally, what do these core rules of the DSHEA make obvious?

They reveal that there is a rather lax or weak official oversight of the nutritional supplement industry in existence.

The US government itself made admission of that:

Weaknesses in the regulatory system may increase the likelihood of unsafe products reaching the market, and a lack of consumer knowledge increases the potential health risks associated with uninformed consumption.” (GAO, 2009) [emphasis added]

Gosh, that's not very assuring, isn't it?

The situation is such that the dietary supplement industry (nutritional supplement manufacturers, or suppliers) should regulate itself on the issues of supplement quality. In other words, you, the consumer, have to rely on the dietary supplement manufacturers' words (or their goodwill) that their products are safe and effective.

That predicament, made possible by lax policies of dietary supplement regulation, presents opportunities for abuse, such as the tendency of food supplement manufacturers to produce low-quality, ineffective discount vitamins and nutritional supplements, in order to maximize their profits.

Much of human history made clear that when certain individuals, or certain groups, have (near) unrestricted authority and power, whereas accountability plummets, the incidence of misconduct, abuse, and fraud increases. Adequate regulation of dietary supplements elevates the accountability and responsibility of supplement makers and promoters which is beneficial for the general public.

When the regulations (and the enforcement thereof) about matters that are important to public health and welfare are weak and inadequate, such as the rules of dietary supplement regulation, abuse and fraud become more common and proliferate among the individuals and groups profiting from the lack of oversight. Most unfortunately, usually this is to the detriment of the many supplement consumers.

Currently, the internet is loosely regulated. As expected, spam, phishing, and other scams are rampant. (Probably the worst, most devastating fraud perpetuated on people, based on this same basic process -lack of regulatory oversight- was when dominant, unscrupulous individuals and groups from the financial sector and the US government itself progressively subverted and disabled existing, effective legislation of the financial sector, which lead to the massive economic meltdown of 2008 in the US -affecting markets and devastated the lives of millions of people world wide -Ferguson, 2010).

In a review study of the supplement industry the researchers concluded with:

“[...] it is obvious that certain members of the dietary supplement industry take great advantage of the opportunity to market products not shown to be efficacious or safe.” (Gibson & Taylor, 2005)

The authors of another study summed up the chaotic reality of the nutritional supplement industry this way:

“The diversity of manufacturers, manufacturing processes, and quality control issues are enormous.” (Gershwin, et al., 2010)

Another paper found that:

“Most patients do not realize the great variability among dietary supplements.” (Gardiner, et al., 2008)

Although the FDA had sent out hundreds of warning letters to a plethora of nutritional supplement manufacturers, the federal officials noted that “non-compliance” with cGMP regulations for supplements remains common, such as “failures of adequate quality control” (Watson, 2012).

No surprise then that investigative research on well over 1,500 health supplements uncovered that most products tend to be of low-to-mediocre quality (MacWilliam, 2007 & 2011).

Bottom line?

The current framework of dietary supplement regulation (the DSHEA) does not give you peace of mind about the quality (safety and effectiveness) of vitamins and health supplements.

And as the regulatory authorities themselves insinuated...

The only assurance of the quality of vitamins and supplements is by selecting products from reliable, quality-obsessed, ethical nutritional supplement manufacturers who put care for your health before their financial profits.

Fortunately, there are always individuals and groups of people who do “the right thing”, no matter the external circumstances. Therefore, this "phenomenon" is also valid for the nutritional supplement market, regardless of its particular juridical setting (the weak enforcement and rules of dietary supplement regulation) that entices to misconduct.

Let's take a closer look at what can or cannot be stated, or claimed, about nutritional supplement products per DSHEA regulations.



Nutritional Supplements And Health Claims:

Restrictions & Confusion Rule!

As already mentioned, since the decrees of dietary supplement regulation do not require of supplements to get approved by the FDA for their safety and effectiveness prior to their marketing, unlike with prescription medications, a FDA disclaimer statement must be on product labels if a permissible nutritional supplement claim is made.

Here is an example of such a disclaimer:

“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” (Official US Government FDA website, accessed Sept. 2010)


Health Claims Versus Disease Claims

The most basic concept is that (certain) health claims are allowed for nutritional supplements, while disease claims are not.

Legally, only FDA-approved prescription drugs can be tied to disease claims. That is, asserting a certain drug can “treat, cure, or prevent” a specific disease or a class (category) of diseases:

“[...] a statement would be considered a disease claim if it explicitly or implicitly claimed an effect on a specific disease or class of diseases.” (Federal Register Final Rule - 65 R 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

And...

“[...] the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim under the FD&C Act [of 1938].” (Sharfstein, 2010) [emphasis & explanation added]

And...

“[...] it has always been illegal to market dietary supplements or other foods with disease claims, except that since 1990 authorized health claims have been permitted.” (Federal Register Final Rule - 65 R 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

And...

“[...] a drug is defined as 'an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,' or 'an article (other than food) intended to affect the structure or any function of the body'.” (Federal Register Final Rule - 65 R 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

Conversely and in contradiction to that, among the regulatory policies for health supplements (the DSHEA) it states:

“[...] appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures.” (Federal Register Final Rule - 65 R 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

Isn't “limit the incidence of chronic diseases” nothing other than a disease claim (of prevention), at least to some extent?

If I “limit the incidence of chronic diseases” it means that I reduce the risk of getting a disease, or a group of diseases. If I reduce the risk of getting a disease it follows that I prevent getting the disease, at least to some degree.

Also...

Aren't “chronic diseases” a class of diseases?

Aren't “chronic diseases” nothing but a set, a group, a category, or a “class” of widely agreed upon specific diseases, such as cancer, cardiovascular disease, arthritis, Alzheimer's Disease?

Confusing?



Three Permissible Supplement Health Claims

-Restricting The Expression Of Truthful Information

“Most consumers are unaware that the Federal government imposes a complete blanket of censorship over health claims in the food and dietary supplement markets.” (Jonathan W. Emord, Esq., Attorney, in 2011)

Per the edicts of FDA dietary supplement regulation, nutritional supplement manufacturers, suppliers, or distributors of vitamins and supplements can make only three basic types of claims about their products:

1) Health Claims:

This is a statement referring to an association between a food, food component, or a supplement ingredient and “reducing risk of a disease or health-related condition” (Official US Government FDA website, accessed Oct. 2011).

A health-related condition is defined as “a state of health leading to disease” (Official U.S Government FDA website, accessed Sept. 2010).

As an example, the statement "diets high in calcium may reduce the risk of osteoporosis" is allowed according to the FDA (Claims That Can Be Made for Conventional Foods and Dietary Supplements, September 2003, Official US Government FDA website, accessed April 2011). But...didn't the FDA clearly explain that claims were impermissible implicating a specific substance, or ingredient of a dietary supplement with the prevention, treatment, or cure of a particular disease (osteoporosis in this case) because that would make it a disease claim?

“[...] the agency has repeatedly taken the position that implied disease claims in labeling subject a product to regulation as a drug.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

And... “[...] dietary supplements 'intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease' remain within the definition of a 'drug'.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

And furthermore, because osteoporosis is apparently not simply “a state of health leading to disease” but a specific disease...

“The following are examples of conditions that would remain disease claims: (1) Toxemia of pregnancy; (2) hyperemesis gravidarum; (3) acute psychosis of pregnancy; (4) osteoporosis; (5) Alzheimer's disease, and other senile dementias; (6) glaucoma; (7) arteriosclerotic diseases of coronary, cerebral or peripheral blood vessels; (8) cystic acne; and (9) severe depression associated with the menstrual cycle.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

Confusing?

Permitted “Special Exception” Disease Claims For Supplements

While federal policies on dietary supplement regulation prohibit the implication that supplements can prevent specific diseases (or a class of diseases), there is an exception to this ruling:

“[...] statements may claim a benefit related to a classical nutrient deficiency disease provided that they also disclose the prevalence of the disease in the United States.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

And... “[...] FDA permits some health claims that are not authorized by regulation but are supported by credible evidence and accompanied by a non-misleading disclaimer.” (Sharfstein, 2010) [emphasis added]

Presumably the FDA regards osteoporosis as a classical nutrient deficiency disease (calcium deficiency). Or the claim "diets high in calcium may reduce the risk of osteoporosis" constitutes a “qualified health claim”, validated by “credible evidence”.

Nevertheless, isn't this permissible health claim an example of a straight-forward disease prevention claim, at least to some degree? If I reduce the risk of getting a disease ("diets high in calcium may reduce the risk of osteoporosis") I consequently prevent getting the disease to a certain extend.

But...

...according to FDA ruling, supplements (or foods) are not meant “to diagnose, treat, cure, or prevent any disease” (disease claims). Here is a direct citation from their official website:

“DSHEA precludes statements under section 403(r)(6) of the act from claiming to treat or prevent disease.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

And...

“FDA agrees that general statements about health promotion and disease prevention may be acceptable, as long as the statements do not imply that a specific product can diagnose, mitigate, cure, treat or prevent disease.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

And...

“FDA points out that the claim that cranberry juice cocktail prevents the recurrence of urinary tract infections [...] is a claim that brings the product within the “drug” definition whether it appears on a conventional food or on a dietary supplement because it is a claim that the product will prevent disease.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

In other words, the claim that “cranberry juice cocktail prevents the recurrence of urinary tract infections” is a disease claim (legally reserved for drug implication only), while the claim "diets high in calcium may reduce the risk of osteoporosis" is a legal health claim (either a “qualified health claim” or an exempted disease claim about a classical nutrient deficiency disease).

Having these statements on a supplement label would mean or imply that both claims implicate a specific food component or a specific product with the prevention of a specific disease or set of diseases.

Confusing?



Contradictions Among The Policies Of Dietary Supplement Regulation

Most fundamentally, and most troubling though...

The definition of a health claim, according to the official policies of dietary supplement regulation, describes the relationship between a food substance or supplement nutrient and “reducing risk of a disease or health-related condition.” The official definition of a disease claim refers to the capacity of a drug “to treat, cure, or prevent a disease”.

What does “reducing the risk of a disease” (health claim) actually mean? How does this terminology compare to “preventing a disease” (disease claim)?

Reduce means to lead (or bring) back per the Latin root of the word (Webster's Third New International Dictionary, 1961, Unabridged). It means to diminish, to make smaller, to decrease. Risk equals the possibility of loss (Webster's Third New International Dictionary, 1961, Unabridged).

Therefore, “reducing the risk of a disease” stands for decreasing the possibility of loss (such as getting a disease), diminishing the chances of a disadvantage (such as getting a disease).

In other words...

It means hindering, obstructing, decreasing the progression or possibility of something unpleasant from happening.

Prevent, on the other hand, means to anticipate, to forestall (Webster's Third New International Dictionary, 1961, Unabridged). It implies an act or move which blocks or delays something from (potentially) happening.

Therefore, “to prevent a disease” stands for blocking, forestalling, obstructing something (such as getting a disease) from occurring.

Bottom line?

“Reducing the risk of a disease” is a partial, or incomplete, prevention (blocking) of a disease. While “preventing a disease” implies the total blocking of a disease.

“Reducing the risk” still encompasses prevention, albeit incompletely.

FDA laws on dietary supplement regulation somewhat contradict themselves. They're very ambiguous.

Moreover, the FDA claims, by implication, that medical drugs can totally block or prevent a disease when they state on their official website:

“They [=dietary supplements] cannot completely prevent diseases, as some vaccines can.” (Official US Government FDA website, accessed Oct. 2011) [explanation added]

If "some vaccines" can prevent diseases...some vaccines cannot “completely prevent” diseases either. What about those? This would put those vaccines into the “inferior” claim's category of nutritional supplements since “incomplete prevention”, according to the FDA, is the same as “reducing the risk”. In their therapeutic effects those particular drugs would be equal to food supplements.

But... they're not treated equally by US law.

Those "therapeutically-compromised" medications are in the “superior” drug status category. So we have some drugs that, also, cannot “completely prevent” diseases... just like supplements (according to the FDA). Why then don't these particular drugs get demoted since they're equal in their partial effects to nutritional supplements? Why not upgrade some supplements into the drug-status claim's category?

Why do drugs get approved if they only incompletely prevent a disease? Why can drugs legally claim to prevent a disease when they cannot do it any more effectively than some supplements? Shouldn't then certain nutritional supplements also get approved as drugs, or officially be equated with drugs?

If “incomplete prevention” drugs got approved because originally they were able to completely prevent a disease but over time they lost in their therapeutic efficacy (as it is the case with a lot of antibiotics, for instance), why let them keep the drug status ranking? How come when they're (largely) ineffective? Why don't they get downgraded?

It's obvious, from that alone, that just because a drug is FDA-approved does not mean that it is actually effective (or safe) in real life.

FDA laws on dietary supplement regulation are contradictory. Apparently, to the public health authorities the upholding of absurd laws is more important than the truthful categorization, advocation, and dissemination of health effects.

So, it is logical, it makes sense, for the public to get and be confused with such a set of dietary supplement regulation, as surveys have corroborated that much of the public is mystified about dietary supplements and health claims.



What Evidence On Vitamin Benefits Is Credible To The FDA?

As pointed out, certain disease claims about nutritional supplements can be made, according to the FDA, if the statements are “supported by credible evidence” (Sharfstein, 2010). These particular statements about specific nutritional supplement ingredients are commonly referred to as “qualified health claims”.

What the FDA considers “credible evidence”, however, appears to be extremely arbitrary and biased.

In an article by an attorney who's very knowledgeable about the edicts of FDA dietary supplement regulation it stated:

“[...] it [=the FDA] has created a rigid construct that categorically rejects review of science that the scientific community considers persuasive, including animal studies, in vitro studies, and clinical trials […].” (Emord, 2009) [explanation & emphasis added]

And...

“FDA thus does not in fact review the totality of scientific evidence but only a small fraction of it, thus erecting a straw man to either deny or saddle claims with misleadingly negative disclaimers.” (Emord, 2009) [emphasis added]

Very few “qualified health claims” get approved by the FDA, from 1999 through 2010, for instance, there were only twelve of them the agency sanctioned but the FDA “usually created disclaimers that completely reversed the meaning of the claim” (ANH-USA, March 2012).

The FDA's use of “misleading negative disclaimers” on legally granted qualified supplement health claims, appears to be a customary way for the government agency to neutralize and impede the freedom of the health supplement industry.

The FDA and their blatant and ongoing (ab)use of their power to render qualified health claims void by way of issuing nullifying disclaimers did finally get reprimanded. In 2012, a judge noted that the terminology of FDA disclaimers of legitimate qualified health claims “effectively negates the substance–disease relationship claim altogether” and must be revised (ANH-USA, March 2012).

FDA's unscientific handling of solid science about certain health claims on vitamins and supplements, and their use of deceptive disclaimers, accomplishes that factual information is hidden, censored, and held back from the public. Truthful facts about the therapeutic effects of food supplements, critical information that can improve people's lives, such as yours.

Arguably most revealing, a survey of FDA scientists documented that 70% of them don't think the federal agency is helping the public get factual science-based information on the use of medicines and foods to better their health (Fromer, 2006).



2) Nutrient Content Claims:

Among nutrient content claims are things like how much of an ingredient is contained in a supplement. This is fairly straight-forward.



3) Structure/Function Claims:

This type of health claim describes how (“the intended benefits”) a nutrient or supplement ingredient affects the structure or function of an already healthy human body.

Examples of such a claim would be, “antioxidants maintain cell integrity”, or “vitamin C helps maintain cardiovascular function”. The mentioning that the consumption of a dietary substance or ingredient improves the general well-being (or memory, or digestion) is also allowed.

But...

“Statements indicating the role of a nutrient or dietary ingredient in affecting the structure or function of humans may be made when the statements do not suggest disease prevention or treatment.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

Thus, the claim “promotes general well-being during the cold and flu season” implies that the supplement can prevent and treat a specific class of disease, colds and flu, and therefore construes an illegal disease claim (Official US Government FDA website, accessed April 2011).

Again, the ruling, akin to health claims, operates in a bit of gray area.



More Contradictions In The Decrees Of Dietary Supplement Regulation...

The statement “prevents bone fragility in post-menopausal women” is not permitted according to the policies of dietary supplement regulation because it implies a disease claim on prevention.

On the other hand, the statement “calcium builds strong bones” is an acceptable supplement structure/function claim, rather than a medication-reserved disease claim on treatment. Even though the "building of bones" is the most basic modality of treatment (just consider the therapeutic approaches to osteoporosis by the medical profession) since virtually any substance capable of "building strong bones" reestablishes and preserves bone tissue.



Nonsensical Rules To Cover Up The Truth?

Beyond all the clear ambiguities and (subtle) contradictions among the edicts of dietary supplement regulation, if a particular nutrient helps to maintain a certain function (or structure) of the “normal”, healthy body, doesn't it quite plausibly and naturally imply -it's a logical likelihood- that the particular ingredient conceivably can help “treat, cure, or prevent” the loss of such a function in an unhealthy, diseased body? Of course it does exactly that, in many instances. Excellent scientific evidence supports these associations.

If calcium aids in building strong bones it consequently helps, or assists, in the prevention of osteoporosis. It has little to do with implying a nutrient of a supplement can help prevent a disease, rather it is a logical, reasonable, and plausible conclusion of its effects on function and structure of the biological organism, whether healthy or sick.

As a consequence, the rules of dietary supplement regulation, especially on health claims and structure-function claims, obstruct and suppress important and scientifically sound information about the full benefits of these natural health products.

The FDA itself admitted that there is a fine line among the definitions and interpretations of these supposedly different types of claims:

“FDA agrees that it may be very difficult to draw clear lines between structure/function claims and disease claims.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

And the FDA acknowledges that the ruling...

“[...] leaves open questions concerning the distinction between structure/function claims and disease claims. Diseases cause, and can be characterized as, abnormalities in the structure or function of the body.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011)

An example of the ambiguous definitions of terms is one of the FDA's definitions of a drug. Because it is exactly what defines a supplement structure/function claim:

A drug is defined as [...] an article (other than food) intended to affect the structure or any function of the body.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

At the same time supplement structure-function claims describe “the intended benefits” of how a nutritional supplement ingredient affects the structure or function of a person's body:

“Statements indicating the role of a nutrient or dietary ingredient in affecting the structure or function of humans may be made when the statements do not suggest disease prevention or treatment.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

Confusing?



Ambiguous Rules Of Dietary Supplement Regulation Lead To Marketing Violations

-How The Uncontrolled Power Of Regulatory Authorities Spawns Abuse

The predicament of not being able to readily distinguish between what can or cannot be stated spurs the incidence of supplement health claim violations within the industry. Even among the orthodox medical profession (in conjunction with the pharmaceutical industry) we apparently find violations in the areas of dietary supplements and health claims and/or structure-function claims.

As an example, inconsistencies and violations of the disease claim provision can be encountered in the Physicians' Desk Reference (PDR), “the most trusted and commonly used drug information reference” (pdr.net; accessed April 2011), both online and in book format. It is a collection of drug information designed primarily for medical doctors.

The PDR is published by the orthodox medical profession, with substantial funding by the pharmaceutical industry (“[...] published […] in cooperation with participating [almost exclusively pharmaceutical] manufacturers” -PDR, 52nd Edition, 1998 [explanation added]).

In the 1998 edition of the PDR it cited the following wording under the categories of 'Actions' and 'Indications' of a specific multi-vitamin mineral supplement product ('Nutrisure'):

[…] designed to […] and can be used to […] prevent chronic diseases […].”

But...what do the policies of dietary supplement regulation say?

“FDA agrees that general statements about health promotion and disease prevention may be acceptable, as long as the statements do not imply that a specific product can diagnose, mitigate, cure, treat or prevent disease.” (Federal Register Final Rule - 65 FR 999 - January 6, 2000, Official US Government FDA website, accessed April 2011) [emphasis added]

This delicate situation is largely a symptomology of an arbitrary regulatory scheme of dietary supplement regulation. Namely, both the FDA and the FTC administrations can always invoke the verdict that disease claims are implied with practically any structure-function or health statement relating to vitamins and supplements that a maker/promoter of nutritional supplements (or a drug company) announces.

As Emord had explained:

"You can prove that the supplement helps people, it doesn't matter, all they [=FDA, FTC] have to do is say, "Okay, you drew an association between your nutrient and a disease"." (Natural News Editors, 2015) [explanation added]

While amorphous muddy dietary supplement regulation nurtures supplement health claim violations, a governing body with unchecked regulatory influence and conflict-of-interests enable and enact the dilemma in the first place.

Emord observed that the plight of obscure unreasonable US dietary supplement regulation means that:

"[...] anyone who is targeted can be prosecuted, in other words, virtually anyone can either be deemed to be engaged in deceptive advertising or making unapproved claims, expressed or implied, and, as a result, once the political determination has been made about who to go after, it's essentially a foregone conclusion that they're guilty." (Natural News Editors, 2015) 

And...

"[...] you don't have the right to a jury trial, that the founding fathers wanted, and put in the Constitution as your essential right when confronted by the government, and you don't have a co-location of power, where the regulator is both the prosecutor and the judge. You've got [the FDA or the FTC who say] "Go after Mr. X," and they issue the orders to go after them. And then, when action is taken, they're the ones who judge the determination of whether or not you're guilty of the violation. And they're the ones that brought the charges, so of course you're guilty. So, there's no justice in that. There's no independent third-party review until after they have determined you to be guilty." (Natural News Editors, 2015) [explanation added]



Consumers Are Confused About Supplement Health Claims...

-Is It A Coincidence?

In case you find these various dietary supplement regulations (or restrictions) confusing...

Well, that's because they are. Just the way the majority of people perceive the domain of dietary supplement regulation (especially the subcategories of health claims and structure-function claims) according to a couple of investigative research publications (Hasler, 2008; IFIC, 2011).

In a government report on dietary supplements it states:

“[...], surveys and experts indicate that consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting labels on these products.” (GAO, 2009)

A closer look suggests confusion is created intentionally to mislead consumers about the true merits of nutritional supplements. The reasons for the profound and widespread confusion is a direct consequence of supplement politics played by the regulatory establishment.

In the aforementioned survey of FDA scientists, 26% of them said that they felt that FDA officials implicitly expect them to provide incomplete, false, or deceptive information, and almost half of the respondents didn't respect the integrity of the FDA decision-makers (Fromer, 2006).

The world of FDA dietary supplement regulation is definitely shady, at best.


(Originally published: ca. July-2012)

(This article is PART 2 of a comprehensive guide to “Exploring The Shady World Of Dietary Supplement Regulation”)

(To go back to PART 1 of “Exploring the Shady World Of Dietary Supplement Regulation”: Dietary Supplement Regulation -Is Supplement Quality Assured?)





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