cGMP Regulations

Aimed At Safety, Not Effectiveness, Of Supplements



Dietary supplement cGMP regulations cover primarily safety aspects related to the manufacturing of supplements. Unfortunately, these particular policies of dietary supplement regulation do not address the central quality problem...

...the effectiveness (or rather ineffectiveness) of supplements.

This means that you most likely continue to buy dietary supplements of low quality (even if they are health food store supplements). That is, supplements that practically don't work. Products which don't give you the health benefits you can get from an outstanding, high-quality, science-based nutritional supplement (such as one of the reliable high potency multi vitamins).

In other words, cGMP regulations allow and enable the saturation of the market with predominantly ineffective discount vitamins and nutritional supplements.

Virtually everything related to the quality of nutritional supplements is totally up to the discretion of nutritional supplement manufacturers or suppliers.

In 2007, the FDA released new, additional regulations -complementing the DSHEA of 1994- addressing specifically the standards of quality in the manufacturing of dietary supplements (FDA, 2007).

Per this amendment, nutritional supplement manufacturers are required to report any serious adverse reaction to their products back to the FDA (Talati & Gurnani, 2009).

The revised supplement quality guidelines of 2007, called the current Good Manufacturing Practices (cGMPs), address such aspects as purity, strength, identity, and quality of a health supplement (Official US Government FDA website, accessed Sept. 2010).



Lack Of Dietary Supplement Enforcement Leaves cGMP Regulations Incapacitated

Unfortunately for consumers, the FDA appears to lack the resources to enforce these more stringent cGMP regulations, as the agency admits:

"In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness." (Official US Government FDA website, accessed Sept. 2010)

In a government report on food supplements it says:

“FDA dedicates relatively few resources to dietary supplement oversight activities, including conducting inspections and developing guidance for industry on key safety-related aspects of DSHEA.” (GAO, 2009)

Corroborating this sentiment, Henry A. Waxman, chairman of the Energy and Commerce Committee, agrees:

"Because of limitations on FDA’s authority and its lack of resources, consumers don’t have the assurance they should that all supplements are safe." (CSPI, 2009)

Pieter Cohen, MD who has published several papers on the regulatory situation of dietary supplements, too concurs:

"Unfortunately, lenient regulatory oversight of dietary supplements, combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity.[...] millions of Americans will continue to be exposed to unacceptable risks […]. ” (Cohen, 2009)

In an article by Consumer Reports on the state of the nutritional supplement industry, it said:

“At the same time, the FDA’s supplement division is understaffed and underfunded, with about 60 people and a budget of only $10 million to police a $19.4 billion-a-year industry.” (Consumer Reports, 2004)

After the first decade of the new century the dismal situation fairly much remains the same.



Pro-Supplement Industry Groups Misrepresent The Facts About The Regulation Of Supplements

The factual predicament on the lack of FDA dietary supplement enforcement doesn't stop the Council for Responsible Nutrition (CRN), a prominent trade association of the supplement industry, to imply in error that health supplements are tightly regulated and that the FDA effectively enforces the regulatory policies of nutritional supplements:

“FDA is charged with inspecting manufacturing facilities, reviewing labeling and monitoring products for safety.[...]. Claims that dietary supplements are not regulated or are “loosely” regulated are inaccurate.” (CRN, 2010)

And...

“Virtually all facets of dietary supplement manufacturing, labeling and marketing are covered by extensive regulations issued and enforced by FDA and FTC.” (CRN, 2011)

Another similar type of group, The Alliance For Natural Health USA
, that supports the non-orthodox wellness industry and its use of natural health treatments and prophylactics (including the use of nutritional supplements) emphatically proclaimed that:

"Supplements and supplement manufacturing are highly regulated." (ANH-USA, 5-June-2012)

It's a misnomer to call an industry "highly regulated" when it regulates itself on the safety and efficacy of their products before they get put out on the marketplace. It's a misnomer to call an industry "highly regulated" when it is poorly monitored in regards to its legal compliance with product safety and quality. It's a misnomer to call an industry "highly regulated" when there are zero guidelines in the DSHEA on what constitutes an effective nutritional supplement based on sound scientific data.



Revealing The Limits (“Loopholes”) Of cGMP Regulations

What is of great importance is that cGMP regulations for supplements do not cover issues concerning the safety and effectiveness of the actual dietary supplement ingredients. cGMP benefits encompass only quality issues pertaining to the manufacturing of the final supplement product in and of itself:

“[cGMPs] focuses on the manufacturing practices of dietary supplements and not on whether certain dietary ingredients are or are not safe.” (Official US Government FDA website, accessed Sept. 2010) [explanation added]

In other words, the 2007 policies do address the problems of contamination of finished products, and inaccurate label claims (too much/too little of a compound as compared to label claims).

But...

cGMP regulations do not focus on either the safety of the actual nutrients used in dietary supplements, nor the effectiveness of a final product.

In a news release named “New FDA Dietary Supplement Guidelines Still Don’t Ensure Safety, Effectiveness before Going on Store Shelves” by the Consumers Union, a non-profit publisher of Consumer Reports, Janell Mayo Duncan alluded to that state of affairs:

“[...], consumers still have no idea if a given product works, or whether it is dangerous.” (ConsumersUnion.org, Friday, June 22, 2007)

The fact is that the cGMP regulations still do not mandate of nutritional supplement manufacturers to present evidence of effectiveness and safety of the finished products prior to distributing and marketing of such products.

In a study Richard Sadovsky and his co-authors demonstrably stated in their conclusion:

“Although there are new regulatory requirements for dietary supplements [the cGMP regulations of 2007], these products will not require FDA approval or submission of efficacy and safety data prior to marketing under the new regulation.” (Sadovsky, et al., 2008) [explanation & emphasis added]



Dietary Supplement Enforcement

-It Is About Avoidance Of (Further) Harm, Not About Maximizing Health Benefits For You

Unmistakeably, DSHEA regulations delegated the FDA to step in, or to take action, against a food supplement -or more exactly its manufacturer or promoter- after it had entered the market.

When you look at the history of FDA interventions of supplements it is apparent that the regulatory authorities usually “come on stage” when there is a problem, when injury is inflicted on people (Jiang, 2009).

Usually this is the case when dietary supplements and risks are involved, such as with supplement contamination.

Another strong area of dietary supplement enforcement encompasses violations of permissible supplement claims (Brackett, 2004). Most often the illegal claims the FDA is cracking down on are statements made by promoters that qualify for drug-reserved disease claims.

A FDA official acknowledged that (currently) the priorities of dietary supplement enforcement are in the areas of product contamination and illegal claims (Sharfstein, 2010; from Official US Government FDA website, accessed Oct. 2011).

Generally, however, the FDA doesn't intervene because a dietary supplement is ineffective.

There were instances where the FDA fined nutritional supplement manufacturers because their supplements did not contain what was stated on the product bottles (Brackett, 2004). Of course, that type of violation could result in either ineffective products, if they didn't contain enough ingredients. Or, the health supplements could be potentially unsafe, if they contained too much nutrients.

Further evidence substantiating the “avoidance-of-(further)-harm” focus of FDA dietary supplement enforcement are the cGMP regulations. As explained, cGMP regulations only cover issues of dietary supplement safety, not effectiveness.

After all, the rules of FDA dietary supplement regulation (the DSHEA) make it very clear that it is entirely up to the nutritional supplement manufacturers, not the FDA, to produce safe and effective products.



The Big Picture On cGMP Regulations

-The Government Isn't Looking Out For "What's Best" For Your Health

Most importantly...

Both the DSHEA and the cGMP regulations do not describe, specify, or mandate what a nutritional supplement ought to contain, according to sound scientific evidence, to give you the maximum health benefits possible.

There are no rules on how much of a particular supplement ingredient should be contained in a product for it to be effective. No rules on the most beneficial ratio among supplement nutrients. No rules on specifying what type of raw ingredients (frequently, there are numerous types of substances to choose from) to include in a product formula to assure its efficient absorption by the body.

In brief...

No rules, no guidelines, no information on what has to be in a nutritional supplement formula so that your health actually benefits.

None of that. Not a word. Not even in the newer cGMP regulations.

This peculiar circumstance surrounding the decrees of dietary supplement regulation is the key reason the market is permeated with ineffective, low-dose nutritional supplements.

Bottom line?

It is quite evident that the core policies of nutritional supplement regulation do not have “your best interests” in mind.

To phrase it differently, with the current legislative framework for vitamins and supplements the FDA (“the government”), is not looking out for what is best for your health.

The FDA, however, does claim officially to look after our health benefits:

It is part of FDA's job to see that the food we eat is safe and wholesome and that the medicines and medical devices we use are safe and effective.” (FDA, Oct. 2001) [emphasis added]

Ironically, the official mission of the FDA (which can be accessed at their website) includes an assurance of health gains ("protecting and promoting your health").

Although... they're not doing too well on either of their official proclamations (protecting and promoting the public's health) because they grant you, for instance, free access to tobacco products, which are devastatingly destructive to human health as has been proven many decades ago already. The same goes for their approval of significantly harmful agents such as apartame, fluoride, mercury dental fillings, and on and on.

In a confidential paper from 1969 a tobacco company executive even admitted:

Unfortunately, we cannot take a position directly opposing the anti-cigarette forces and say that cigarettes are a contributor to good health. No information that we have supports such a claim.” (Brown & Williamson, 1969)

But the FDA wants YOU to believe they're feverishly working “to protect and promote your health” (Official FDA website, accessed June 2012).

Oh, and let's not forget the massive destruction from alcohol. And prescription drugs which are one of the top frequent causes of death in the US, all of it fully sanctioned by the US government.

By the way, the same “not-what's-best-for-you” approach, as exemplified by the cGMP regulations, is evident with the human food supply. The government agency responsible for food safety, the USDA, is focusing its efforts on making sure the food you eat is safe, rather than on also making sure the food available on the market is nutritious, wholesome, and promotes your health. Like the FDA, however, the USDA too falls way short on their primary area of oversight (i.e., protecting the public's health), as Eric Schlosser had uncovered in his best-selling book “Fast Food Nation” (2002).

There are comforting words and slogans. And there are actions and accountability. There are misconceptions. And there is objective reality.

Trust facts, not authorities.



What DSHEA & cGMP Regulations Ultimately Mean For You

-Nutritional Supplement Manufacturers Should Regulate Themselves... But Do They?

The US government admitted and made it clear that...

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

In other words...

The official dietary supplement regulations do not protect you from consuming unsafe and/or ineffective nutritional supplements.

Supplement guidelines (including cGMP for supplements), mostly regulatory drawbacks, enable, invite, and even encourage, certain types of dishonorable, but legally ratified, actions by both nutritional supplement manufacturers (and suppliers) as well as the official authorities of dietary supplement enforcement, the US FDA (Food And Drug Administration).

Both parties' mode of operation, in a symbiotic manner, make it a reality that the marketplace is saturated with low-quality, ineffective discount vitamins and nutritional supplements.

The situation is such that nutritional supplement manufacturers and suppliers get away, legally, with producing low-quality, ineffective health supplements. For example, with products that do not give you the maximum health benefits possible according to substantial, solid, scientific evidence and extensive clinical experience. Or products that don't contain what is on the supplement label.

Why did the introduction of the cGMP regulations not change this reality? Because those policies do not deal with supplement effectiveness, and because the FDA's attempts of dietary supplement enforcement remain lackluster.

Moreover, in regards to the public health authorities, restrictive FDA supplement regulations are stopping anyone from stating all the facts (the whole truth) about vitamins and supplements. Which, in turn, directly facilitates, supports, or entices numerous nutritional supplement manufacturers to produce low-quality, ineffective food supplements. All neatly nestled within the legal parameters of the regulation of dietary supplements.

The consequence?

Chances are high you (will) take health supplements that either:

  • have a potential (but probably minimal) safety risk,
  • and/or,

    ... and much, much more likely...

  • do not give you the assumed, expected, promised, or vaguely implied health benefits you may think you're getting. They do not give you the most attainable, the maximum, health benefits possible, as reliable science has proven indisputably that high-quality, scientifically well-designed nutritional supplements (e.g., high potency multi vitamins) are capable of delivering.



The Supplement Industry Defends Allegations About Domination Of The Market By Ineffective Products

Some nutritional supplements manufacturers and other proponents of food supplements, largely in an attempt to protect their own interests, disagree with the contention of a market flooded with cheap, low-quality, ineffective products. They argue that it is in their best interest to make effective, high-quality nutritional supplements, thereby keeping customers.

Well, first of all, a lot of people have a propensity to keep doing things if they are made to merely believe it is of benefit to them. Especially if the things are approved, sanctioned, and repeated ad nauseum by public health authorities, experts, and the media. How often have you seen a commercial for "one a day vitamins"?

In addition, most people, unfortunately, fail to recognize the true value of their health and tend to make purchasing decisions based on cost rather than value.

Moreover...

Numerous ambigious-confusing policies of dietary supplement regulation suppress the expression, by anyone, of a remarkable amount of truthful information about supplements and its benefits.

The result?

  • Much of the public is at a disadvantage, is unable to accurately assess and pass judgment on what top quality, effective vitamins and supplements are (i.e, true value), simply because, oftentimes, consumers don't know about this unpublished, concealed information. Consumers, frequently, don't know what's best for them because they don't know what a supplement of high quality is.
  • Chances are reasonably high that the majority of products are not based on reliable, sound and complete scientific data. In particular because most nutritional supplement manufacturers, nutritional supplement companies, or supplement promoters don't employ an adequate, comprehensive team of scientists, who are profoundly knowledgeable in nutritional medicine, biology, chemistry, and about the latest data on nutrition and supplement research.
  • To phrase it differently...

    Many nutritional supplement companies or suppliers don't know what an effective, high quality supplement is because it is not uncommon that they are basically a bunch of marketers or promoters, rather than qualfied scientists.

    What's the consequence?

    Lots of nutritional supplement manufacturers and suppliers fail to design and produce the most effective, beneficial supplement formulations currently possible.

To make matters worse, a lack of adequate enforcement of food supplement regulations by the resource-strapped FDA facilitates the manufacturing and promoting of cheap, low-quality nutritional supplements.

Probably the most accurate and eloquent metaphor, describing this environment, came from Bruce Silverglade, from the Center for Science in the Public Interest (CSPI), when he said...

"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)

Although, the FDA did step up its enforcement of cGMP regulations every year since their inception in 2007 (Daniells, Nov. 2011). The FDA even began a more hands-on supervision of social media sites for claims infringing on cGMP regulations (Daniells, Jan. 2012), and fined numerous nutritional supplement manufacturers for violations thereof (Daniells, Dec. 2011). However, the situation overall appears to remain fairly much the way Silverglade described in the early years of the first decade of the 21st century. For instance, the rate of FDA Warning Letters sent out to nutritional supplement manufacturers, addressing violations of FDA laws and of cGMP regulations fluctuated very dramatically from year to year between 2008-2011, revealing a lack of consistency in oversight (Wasserman & Sutton, 2012).

Loren Israelsen, a spokesperson for a pro-supplement industry watchdog organization (United Natural Product Alliance/UNPA), whose “core mission is to help assure the full and proper implementation and enforcement of DSHEA” (UNPA's official website, accessed Jan. 2012), remarked in disappointment:

“There is a general low level of GMP compliance. This could be economic in terms of the cost to implement or it could be that the threat versus reward ratio is not balanced.” (Daniells, Nov. 2011)

Maybe most convincingly, substantial independent data validates the notion that a marketplace saturated with low-quality, ineffective cheap supplements is actually in existence.

Lyle McWilliam's investigation of over 1,500 nutritional supplements reveals that the market is permeated with low-quality, non-science-based, ineffective products (MacWilliam, 2007 & 2011). Another report, similarly, documented a tremendous difference in supplement quality among products available on the market:

“Marketed products containing dietary supplements may vary significantly. Even different batches of the same product from the same manufacturer may differ in content and potency. […]. Most patients do not realize the great variability among dietary supplements.” (Gardiner, et al., 2008)

Besides the common occurrence of supplement formulas which are not rooted in solid science, another reason why ineffective supplements are the norm is because the products frequently don't (exactly) contain what is written on the bottle. A snippet from The Wall Street Journal, referring to a FDA report, acknowledged this:

“How do I know if I’m buying a reputable brand? You don’t. Numerous studies show supplements often don’t contain the ingredients they promise, and some are adulterated with lead or other contaminants.” (The Wall Street Journal, “New Rules From FDA Offer Little Supplement-Safety Aid”, March 11, 2003)

Although the cGMP regulations of 2007 address the accuracy of label claims, it remains a significant problem after the legislative implementation of the cGMP regulations.

With free access to supplements, combined with...

...a lack of stringent legal guidelines to set high standards for the quality of dietary supplements, particularly for effectiveness,

...a lack of adequate FDA dietary supplement enforcement, and

...crushing regulatory restrictions on publicizing the full extent of benefits achievable with high-quality, science-based health supplements,

...the entire market got flooded with nutritional supplements of inferior quality.

It still is today.



Summary...Key Points At A Glance

-No Peace Of Mind About The Quality Of Supplements

To recap, the circumstance of having loose laws of dietary supplement regulation (DSHEA), combined with the severe lack of supplement enforcement, is such that...

  • You don't have a solid assurance, you don't have peace of mind, about supplement safety (as far as the toxicity of a specific nutrient concerns, or whether the finished product is pure or contaminated),
  • You don't have a solid assurance that supplements are effective (will benefit your health),
  • You don't have a solid assurance that supplements contain exactly the quantities of nutrients listed on the label.



Can You Rely On The Government For Assurance On Supplement Quality?

A statement in an article on supplements by Consumer Reports, released in 2004, is still valid and neatly sums up the state of affairs on FDA nutritional supplement regulation (including the 2007 cGMP regulations) after the first decade of the 21st century:

“Until the law is substantially changed and the FDA is adequately funded, you cannot rely on the federal government to ensure that dietary supplements are safe and effective.” (Consumer Reports, 2004) [emphasis added]

The US government corroborated this with the following declaration:

“Dietary supplements are not approved by the government for safety and effectiveness before they are marketed.” (Official US Government FDA website, accessed Oct. 2011)

Unfortunately, nutritional supplements are about your most valuable and precious asset...your health. So you probably ought not consume products compromised in quality.


(Originally published: ca. July-2012)


(This article is PART 3 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?)

(To go back to PART 2 of “Exploring the Shady World Of Dietary Supplement Regulation”: Dietary Supplement Regulation -No FDA Approvals For Supplements!)




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