Regulatory Issues: The Long Version

Supplements and Regulations

The FDA is going to ban all supplements! The Codex Alimentarius is going to cause supplements to be prescription-only here in the U.S.! Supplements are horribly dangerous! Supplements have no physiologic effects whatsoever!!

Sorting through the truth about what supplements can do, how and when they can help and what the laws are all about regarding them is no easy task. Pools of interested parties compete for our attention. The manufacturers and purveyors of dietary supplements resist regulation. Some trade organizations, such as the Council for Responsible Nutrition accept the need for some regulation (e.g., for quality products and ethics). By contrast, some in the government and some consumer advocate organizations would like to place heavy restrictions upon them and even deny access altogether (e.g., to herbs considered dangerous, such as chaparral, comfrey and others). Yet others, notably in the drug industry, fear their potential to compete with highly profitable, costly and often toxic drugs.

So who to believe? There is yet another pool of interested people. Those of us who USE these interventions: the consumer. Here at NYBC, we are living with chronic diseases such as HIV, hepatitis C, chronic fatigue, Lyme disease, among others, not to mention the simple fact we’re all getting older. So while we sell supplements, we do so both as a non-profit and as people living with chronic disease. Where vitamin stores may try to get you to buy more and more, we are more interested in understanding if, when, how and why to use supplements to manage health, offset side effects all while trying to assure it fits in your budget. Is it a help? Is it a waste of time? And for this article—is the very access to supplements under threat?

Basics
The term dietary supplements has a specific meaning within the laws and regulations of the Food and Drug Administration (FDA) of the United States government. By the FDA definition, a dietary supplement “is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.” Further, it:
• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a “dietary supplement.”
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

Regulations for dietary supplements were carved out in legislation known as the Dietary Supplement Health and Education Act of 1994 (DSHEA) that President Clinton signed into law in 1994. It was an amendment to the 1938 Federal Food, Drug and Cosmetic Act, which gave FDA the authority to evaluate the safety and efficacy of a range of products on the market. The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations. The law also requires formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health. (Source: http://www.cfsan.fda.gov/~dms/dietsupp.html, 3/7/2006).

Current Efforts to Reform/Amend DSHEA
Often, we hear that dietary supplements live in some kind of wild west of no regulations and freewheeling. This is inaccurate. Indeed, the DSHEA gives FDA numerous opportunities to oversee what is on the shelf—but they have failed to do so. To the extent that FDA exerts such powers, it has been largely to go after supplement companies who make claims that a product can affect a disease condition. We look at this more in a moment.

One widely-shared concern about ALL products is quality, including:
Identity – it is what it says it is;
Purity – it doesn’t have adulterants or contaminants (and the label FULLY explains all ingredients)
Potency – it has the amount claimed (i.e., 500 mg of acetyl-L-carnitine, not 425 or 900)

On FDA’s website, they note
Does FDA routinely analyze the content of dietary supplements?
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. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. …

In other words—they COULD be evaluating supplements—but they’ve never bothered to lobby Congress for the funds, equipment and people-power to do so! Why not? This is the kind of jobs creation America needs! This is the kind of effort that will assure that our food, dietary supplements AND drugs are in what they say they are and excellent quality. THIS is how it would be nice to see our tax dollars spent; employing more people to do the good work of assuring the safety and quality of the products we consume, that our very LIVES depend upon!

Once the product is in your hands and you are consuming it, other aspects come into play, including Safety, Bioavailability and Efficacy. Safety refers to the potential for ANYTHING one consumes to cause problems. A drug like AZT can have a range of side effects. And a peanut can be lethal if you have an extreme allergy. For the most part, dietary supplements are much safer than over-the-counter medications, though problems may arise if too much is used (e.g., high doses of selenium are toxic); it may have side effects (as mild as GI upset to liver toxicity) or it may interact with medications (like St. John’s wort).

FDA has developed a system to enhance reporting of adverse events related to a dietary, but it is a passive effort. If you think a supplement has caused some kind of negative effect, you and/or your physician may report this. While for the most part, the potential for side effects is pretty well understood for the majority of dietary supplements (as they are defined at the outset, from historical empiric observation, to be Generally Recognized As Safe (GRAS)), some newer agents and even older ones may present with hitherto unobserved effects. Understanding the complete range of potential side effects is critical to making a rational assessment of therapeutic options. That doesn’t mean something should be removed from the market. For example, people with peanut allergies can face death and, understanding their risk, assiduously avoid peanuts. Those that can consume them safely may continue to do so. In the meantime, it remains unclear how robust this new system is or how it is working.

Bioavailability refers to how well one’s body absorbs the substance or, in the case of a botanical (or “herb”), some active constituents. Efficacy is whether it does what it claims to do. It’s that “claim” bit that gets regulators in a tizzy—and also some in the pharmaceutical industry who view with some considerable agitation the potential threat that any competition represents to their profits.

Claims about the effect of a dietary supplement are limited to “structure and function.” For example, one can talk about vitamin D3 and calcium sustaining bone strength. Any such claims on an effect on structure or function must be accompanied by a statement prescribed by DSHEA, one you have no doubt seen many times: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

By contrast, claims about Efficacy to treat, mitigate or cure a disease are forbidden without the FDA’s approval. This approval can only be undertaken should the supplement be classified as a drug and undertake all the onerous and costly steps of new drug approval, including extensive clinical trials. The “wild west” that we live in is one where pretty much only for-profit companies (and the hospitals, physicians and clinics they buy), can bring a drug to market. If the drug is one for which there is no exclusivity of a patent, they cannot “corner the market” (and extract whatever price “the market will bear”) for that product. This horrifying state of affairs has resulted in clinical trials for pharmaceutical drugs being degraded into mere tools for marketing rather than a robust approach to evaluating the benefits, limits and risks of any intervention, let alone outrageous pricing.

Should a company decide to advertise a supplement (or food) has a benefit, say for lowering cholesterol, the Federal Trade Commission (FTC) may get into the act, along with the FDA. In many cases, this is undoubtedly a legitimately used tool to address some of the outrageous claims made about some dietary supplements. However, the agency has also gone after companies who have provided scientific support for an intervention’s efficacy. This is the risk and the constant battle.

Unfortunately, with either structure/function claims or efficacy, the FDA has basically done little since DSHEA was enacted in 1994. There are only a few approvals of efficacy for supplements or structure/function claims have been made in the past 16 years. We urge FDA to develop a mechanism and methodology to assemble experts to evaluate the literature and make approvals of claims in a timely fashion.

Robust rulemaking for complete transparency regarding any potential conflicts of interest for government employees is of course critical to assuring public trust. Such rules exist but are haphazard and relatively weak—we’ll consider them in another piece. This can be compromised by the revolving door from government into industry and the noxious influence of industry insiders writing self-serving legislation. A fascinating list of officials who moved into highly lucrative private companies may be found by clicking this sentence.

New Legislation
The Senate Food Safety Modernization Act bill (S.510) and its companion House bill HR875 is essentially designed to address issues arising out of incidents like the recall of billions of eggs in the summer of 2010 for salmonella contamination, among other issues (such as E. coli contaminated spinach and so on). It would amend the Federal Food, Drug, and Cosmetic Act and provide regulators with the capacity to punish offenders with increased fines and prison sentences of up to 10 years. It has yet to be voted upon as of early November, 2010. [You can read the Summary here http://www.govtrack.us/congress/bill.xpd?bill=s111-510&tab=summary as well as the full text.] Part of the issue here is that it is being merged with language from S.3767, Senator Patrick Leahy’s original bill. S.510 essentially had exempted dietary supplements from the purview of the bill, but the original Leahy bill did have relevant language.

The Bill may have an impact on organic farmers by requiring potentially duplicative oversight. On the other hand, potentially onerous user fees have been rejected. Other more legitimate criticisms with regard to food are articulated by Organic Consumers organization. While a complaint that some of the bill’s language may be onerous for smaller businesses to fully comply with, by contrast, the need for assuring safe and pure products is unquestioned and in principle we support the bill. There are concerns all over the internet that the bill would prohibit any growing of anything from seeds and sharing food from your garden without federal oversight. This is simply right-wing hysteria and outright lies.

With regard to dietary supplements, the problems have been to what degree FDA may be given powers that are beyond the law’s intended purview—the language of the bill may sound good but the devil is in the interpretation. For example, the Leahy bill includes language that would seek jail terms for people who knowingly or recklessly adulterate or misbrand products. Which sounds eminently reasonable! What would not be so reasonable is if FDA were to interpret this to mean they have latitude to threaten imprisonment to anyone who cited scientific literature to discuss a product as a form of “misbranding.” Thus, the concerns turn on the precise definitions of “misbranding” and “adulteration” which some view as potentially being distorted by overly FDA zealous officials to use the law and its threat of incarceration to cow anyone who would dare share scientific data that underscores a therapeutic effect.

The definitions for these terms are found in the Food, Drugs and Cosmetics Act, specifically Sec. 403 [21 USC §343] Misbranded Food and 402 [21 USC §342] Adulterated Food. Each of these has specific language for dietary supplements. Misbranding means that a product is not what it says it is. To comply with the law, a label must have certain information that should reflect the actual contents, including:

(s) Dietary supplements.
If—
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails to list—
(i) the name of each ingredient of the supplement that is described in section 201(ff); and
(ii)(I) the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to identify the product by using the term “dietary supplement”, which term may be modified with the name of such an ingredient;
(C) the supplement contains an ingredient described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived;
(D) the supplement—
(i) is covered by the specifications of an official compendium;
(ii) is represented as conforming to the specifications of an official compendium; and
(iii) fails to so conform; or
(E) the supplement—
(i) is not covered by the specifications of an official compendium; and
(ii)(I) fails to have the identity and strength that the supplement is represented to have; or
(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.

(t) Catfish. 6 If it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae.

With regard to adulteration:
(f) Dietary supplement or ingredient: safety.
(1) If it is a dietary supplement or contains a dietary ingredient that—
(A) presents a significant or unreasonable risk of illness or injury under—
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code, to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a violation of paragraph 4 (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices.
(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.

Interestingly, the definition of adulteration allows specific exclusion for pesticide chemical residue on unprocessed or raw agricultural items, food and color additives as well as new animal drugs (like meat filled with antibiotics).

Specifically, one trade industry group, the Alliance for Natural Health says, “the FDA contends that any food or supplement producer who mentions the potential of a product to prevent or treat disease is guilty of misbranding—even if they have piles and piles of scientific research from Harvard or some other top institution. So this bill would create a potential ten-year jail term simply for citing the best science.” There is a clear distinction between misbranding that is outright fraudulent (i.e., selling black cohosh that is actually lawn clippings) and good faith efforts to provide information about the relative scientific merits of a potentially therapeutic effect. Clearly, if a manufacturer sells products with adulterants in it or made out of grass clippings, we say “nail ‘em!” But good faith efforts to discuss scientific evidence should not be prosecuted with threats of jail time if there is a good faith effort to provide clear references to scientific data. UPDATE: It appears the Food Safety Law passed WITHOUT the onerous prison sentences…

A good overview of the various US government agencies, including the USDA, FTC and Dept. of the Treasury, that oversee food to assure it is not adulterated or misbranded is here.

Overall, we at NYBC support the Food Safety bill, particularly if language can be added that clarifies that FDA should not abuse its authority or waste precious resources on assaulting legitimate efforts to sustain our health. Indeed, we support a positive role of government in weeding out and, where necessary, prosecuting the unscrupulous. As noted, we advocate significantly increased resources for FDA to set up labs around the nation to routinely evaluate dietary supplements found on the market, publishing ALL data and findings transparently on a website and issuing alerts for products found to be inadequate or adulterated or also if they passed the tests.

The International Situation
Laws affecting what we here in the US refer to as dietary supplements vary from nation to nation. We will touch on a few of concern to people living with chronic diseases, but a more complete survey is beyond the scope of this article.

In Europe, member nations of the European Union are having their laws harmonized with respect to a wide range of policies. The two main pieces of legislation we briefly review here are the Codex Alimentarius and the Traditional Herbal Medicinal Products Directive (THMPD).

The Codex is “a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety” (For more info, click here). Overall, the general principles of assuring food safety are sound and important. However, a fly in the ointment arose when a delegation from Germany insisted that dietary supplements should be reclassified as drugs. This happened in 1996 and while it was agreed to, loud protest halted its implementation. In 2005, “Guidelines for Vitamin and Mineral Food Supplements was adopted by the Commission. These guidelines were ostensibly meant to help prevent people from overdosing on vitamins, claims the UN’s Food and Agriculture Organization (FAO) and to assure the product safety. (Obviously, in nations with robust, comprehensive healthcare for all, getting a prescription and having it covered under the national health program would be a boon in some respects. We don’t have that here so we argue that if you’re going to start harmonizing, we should have a) health care for EVERYONE, b) access to providers informed about the use of dietary supplements and c) complete coverage.)

To the extent that this concern is true, it is rational. To the extent that these Guidelines may serve as a stepping stone to more restrictive laws that prohibit access to supplements, we object. Each EU nation is grappling with this—but sadly, it would appear that science is left in the lurch, as are we who are trying to survive and thrive despite chronic disease.

In the United States, there is a concern expressed by many that the Codex will somehow affect access to supplements by forcing us to change our laws to “harmonize” with the Codex Guidelines. One consumer protection group, the Center for Science in the Public Interest, has analyzed the potential and points out ways in which the Guidelines may be addressed in a June 1997 report. This group sees Codex as potentially diluting some of the more stringent standards in the US (e.g., for bottled water). By contrast, CSPI supports MORE restrictive laws for dietary supplements. Interestingly, they note that “The U.S. delegation told the Committee that herbal medicines in the U.S. are regulated as dietary supplements pursuant to the DSHEA, and need not be reviewed for safety or approved by the FDA prior to marketing. The U.S. delegation, however, did not fully inform the committee about the difficulties that the FDA has had trying to restrict the sale in the U.S. of harmful herbs such as ephedra, chaparral, comfrey, and other substances.” This hardly paints a picture of an overly draconian FDA! (By contrast, as with substance like tobacco and alcohol, restricting the sale of substances should not be in the purview of the government. Assuring adequate labeling to identify risks is what is important. Ephedra is safe in normally used doses for most people; athletes or others who use excessive doses do so at their own risk…as people do when they smoke, drink, bungee jump, etc. Prohibition may be good for the prison industrial complex but it doesn’t solve anything. However, not all of us at NYBC agree with this idea and some feel that FDA has a duty to restrict sales of harmful products…yet, while tobacco has fallen under their purview in recent years, and cigarettes clearly kill, they remain for sale…but the topic is clearly controversial!)

A second area of concern is the Traditional Herbal Medicinal Products Directive (THMPD), destined to become law on April 1, 2011. This EU law was designed explicitly to address the use of botanical agents, requiring “herbs” have licenses in order to be sold on the market. While it has relatively successfully been able to evaluate and license many European botanical agents, it has left aside botanicals from other nations—and thus the benefits of entire realms of healing knowledge as reflected in the systems of Chinese medicine and Indian traditional systems of medicine like Ayurveda, Siddha and Tibetan medicine.

While practitioners may be able to prepare their own formulae of raw herbs, finished products will not be permitted. Thus, if you live in Britain or France and want to use Health Concerns’ Marrow Plus, for example—you will be “protected” from doing so by the EU government, unless they are able to obtain a license which doesn’t seem likely. (Currently, the EU Commission is also negotiating a “free trade” deal with India that may have the horrific impact of denying their capacity to make available antiretrovirals as generics with generic pricing; to our way of thinking, this is akin to a form of economic genocide). Whether this law will impact the United States is unknown, however you can be sure regulators will be watching keenly to see how it plays out in Europe.

Finally, one serious concern has been raised with regard to harmonization of laws, specifically regarding free trade agreements with central America (CAFTA). Some concern has been raised that passing CAFTA will result in a requirement to harmonize laws, which may represent a bigger threat than Codex if a Central American member nation has more stringent laws about dietary supplements that we have to match. Unfortunately, the major proponent of this view is Ron Paul, the libertarian representative from Texas. While in general we view the effects of free trade agreements as being deleterious most frequently to the poor and working classes both here and in affected Central American nations, it remains unclear how much of a risk CAFTA would pose to domestic law. The US Trade Representative disputes this flatly.

In all, the stew of laws and regulations bear close watching. We must advocate from our perspective of consumers and users of dietary supplements (and mainstream drugs!) We want to know what we use is safe and of good quality, whatever the source. The recent fine of $750 million levied against Glaxo SmithKline for knowingly distributing contaminated and falsely labeled drugs being a prime recent example.

And there’s more. We advocate for comprehensive, robust and ongoing evaluation of the identity, potency and purity of products by the FDA. For NIH, we advocate for funding for more clinical studies to evaluate dietary supplements. We want an even more robust, better funded National Center for Complementary and Alternative Medicine (NCCAM) to conduct clinical studies on the efficacy and limitations of micronutrients, botanicals, hormones like DHEA, fatty acids and other agents.

We further advocate for a more streamlined and appropriate process for FDA to review both structure/function and therapeutic claims. It took FDA nearly 40 years, despite mountains of data, to recommend folic acid supplementation for expectant mothers to prevent neural tube defects—it’s hardly as though there are not myriad other ways dietary supplements can help and improve our lives.

We know. We see it every single day.

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