In its February-April 2012 issue, HerbalGram, one of the most reputable and distinguished journals in the world on all things herbal, published a definitive article: "The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled" by R. William Soller, PhD, Holly J. Bayne, Esq. and Christopher Shaheen. It is intended, and I think aptly succeeds, to dispel as myth the frequent accusations by respected medical pundits that the dietary and herbal supplement industry is unregulated.
To reinforce the thesis of this article I offer my own summary and views on the Dietary Supplement Health and Education Act (DSHEA) and how this industry is regulated, including the effects of California's Proposition 65 on the regulation of herbs sold in California based on state law, distinct from federal requirements. Finally I offer my own view that what most critics really mean when they say "unregulated" is that the dietary and herbal supplement industry is not regulated like drugs.
On the face of it, it is absurd to say that an expanding $61 billion per year dietary supplement industry would have no regulatory standards.
(While there were regulations of the health supplement industry before the passing of DSHEA in 1994 by the 103rd session of Congress, and some of these are still relevant, for all practical purposes this blog refers to post-DSHEA regulations.)
DSHEA marked a turning point in the U.S. of a prolonged period of repression of dietary supplements and herbs by federal authorities under the aegis of the FDA. It is important when assessing the present state to appreciate that DSHEA passed as a result of the greatest write-in campaign in history. It represented a major defeat of the increasingly repressive policies of the FDA and its director at that time, David Kessler.
It didn't make any difference what party one belonged to, the vast majority of people of all political parties, class and demographic allegiance wanted more open access to health supplements.
To pass a bill into law is one thing, but it can take years before enforcement policies and procedures are in place. In this case we were dealing with a federal agency that had just suffered a major political referendum in the polls. So by circumstance or design, during the first few years it appeared that the FDA was not doing its job or was in the process of regearing to execute their new enforcement responsibilities.
Instead of appeasing critics' complaints that dietary supplements are an unregulated industry, they modified their complaint from "no regulation" to the FDA lacking sufficient enforcement powers. The fact is that for the first several years after the passage of DSHEA it appeared that the stunned FDA did seem to abrogate its enforcement obligations which further fanned the derogatory criticisms of an unregulated industry. The Herbalgram article points out a suspicion of many that "the FDA chose a regulatory posture of studied inertia, hoping that wildcat fringe marketers would cause an implosion of the industry as a whole."
The Ma Huang Ephedra Debacle
Some believe that the FDA was lax in the early years of DSHEA to allow the natural supplements industry to hang itself. This almost happened with the following scandal that occurred soon after the bill passed.
Ma huang (Ephedra sinica) is a medicinal herb known to contain pseudoephedrine alkaloids that stimulate the sympathetic nervous system. There are many species of ephedra throughout the world but only the Asian and Chinese species contain enough of the ephedrine alkaloid that is a sympathetic nervous system stimulant (speed). The American species, E. nevadensis et al., also known as "Mormon tea" either contains none or only minute amounts.
In 1997, the serious side effects from the abuse of ma huang prompted the FDA to propose a ban under DSHEA's "significant or unreasonable" risk safety standard to propose a ban on products containing 8 mg or more of ma huang. It further mandated that companies selling products containing ma huang state the possible health risks such as heart attack, stroke or death on the labels of their goods.
Because of the amount of money already coming from the sales of these diet products, the companies banded together to create the Ephedra Education Council. Metabolife alone spent more than $4 million between 1998 and 2000 lobbying against state regulation of ma huang in Texas. Business Week reported that efforts to regulate ma huang and other potentially harmful supplements had been "beaten down by deep-pocketed industry lobbying."
The legal wrangling between the supplement industry and the FDA took place over a three-year period. This further served to fan the flame of criticism and complaints by opponents who saw industry tie up the FDA in legal battles while ongoing reports of injuries and adverse events from the use of their products were registered. Metabolife alone received 14,000 complaints of adverse reactions which resulted in the co-founder of Metabolife being sentenced to six months in federal prison for failure to submit these reports to the FDA as mandated by DSHEA.
Thus, a multimillion-dollar legal resistance coupled with a weakened and lax FDA prevented the enforcement of any regulations set in place by DSHEA.
The final nail in the ma huang abuse coffin was when Steve Bechler, a pitcher for the Baltimore Orioles, died of complications from heatstroke in 2003. The medical examiner deduced that ephedra toxicity played a "significant role" in Bechler's sudden death. As a result, Congress dropped all of its objections to an ephedra ban and demanded action from FDA.*
Notably absent was any comment from the community of U.S. herbalists, either individually or through the then fledgling professional organization, the American Herbalists Guild (AHG), regarding the dangerous abuse of ma huang by the supplement industry.
In short, the FDA initially recommended a reasonable solution by limiting the amount of ma huang in a product to 8 mg. Failure of cooperation by the dietary supplement industry united under their professional organization, the American Herbal Products Association (AHPA), led Congress to demand that the FDA intervene. The result is that neither ma huang nor any ephedrine alkaloids are allowed to be added to dietary supplements.
At present, ma huang seems to be available only in crude whole form and only to licensed Chinese herbalists. The FDA also will not allow the herb to enter through U.S. docks directly from China, though the importing relationship with Taiwan may be different. Other botanicals also containing ephedrine alkaloids, such as bitter citrus peel, are being closely watched by the FDA.
Brief Overview of DSHEA Regulations
The purpose of DSHEA was to create a class for dietary supplements that was neither food nor drug.
The claims that can be made on the labels of dietary supplements and drugs are different. Drug manufacturers may claim that their product can diagnose, cure, relieve, treat or prevent a disease. Dietary supplements or food products cannot claim to cure a specific named disease and may only contain three types of claims: a health claim, nutrient content claim, or structure and function claim. A health claim is based on the relationship between a food, food component, or dietary supplement ingredient and a possible reduction in risk of a disease or health-related condition. All ingredients must be specified on the label with nutrient content describing the relative amount of a nutrient or dietary substance in a product. All structure and function claims are statements that describe how a product may affect the organs or systems of the body without mentioning any specific disease.
Structure and function claims do not require FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market. Product labels containing such claims must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
Under DSHEA, the FDA has the power to withdraw any product based on whether it is illegally adulterated or poses a "significant or unreasonable" risk.
The bill includes provisions for Good Manufacturing Practices (GMPs) to be gradually phased in. This has been occurring over the last five years.
If the political events of recent years have shown us anything they have shown that 1. No one who is succeeding in the market wants to be regulated; and 2. Regulations are needed to protect the consumer from the excesses of the marketplace as well as to uphold the integrity of the companies and individuals who are being regulated. So in a word, recent years have been a period of reassessment of the value of regulations in all areas including the dietary supplement and herb industry. The most counterproductive thing that we can do now is to continue to energize the "us against them" stance that could slow down any progress toward benefits for all.
California's Proposition 65
Besides federal regulations, state regulations play an important role in the commerce of herbs.
Ever wonder what the little sticker on an herbal product that says "this product contains chemicals known to the State of California to cause cancer, birth defects and/or other reproductive harm" means? Does it really mean that if you knowingly take this product intended for your health, you a placing yourself at risk of getting cancer or giving birth to a two-headed baby? The short answer is, absolutely not. The controversial bill became law in 1986 as "the clean air and water bill." It was originally intended to protect consumers from exposure to chemical and industrial contaminants.
Opportunistically, a San Francisco legal consortium has made it their mission to test herbal products sold in the state of California to see if they are compliant mostly in terms of heavy metal content, with the provisions of Proposition 65. Some heavy metals such as mercury, cadmium, aluminum, arsenic and lead are toxic and serve no health function. Others such as zinc and iron are essential for health. Heavy metals are ubiquitous. Some are naturally occurring, while others are toxic byproducts from industrial waste. Plants have the ability to take these and other minerals up from the soil and in some cases transmute them into less toxic forms.
This is very different from the presence of heavy metals in water and air from which no one can escape. Conventional foods and municipal aters were exempted from Prop 65 based on municipalities setting their own limits and the FDA establishing limits for foods prior to Prop 65. While herbal supplements are tested in parts per million (GMP, USDA standards for heavy metals), Prop 65 standards as it applies to water and air is in parts per billion. Organic produce, including infant foods would also fail to meet these standards. Yet, the food and produce lobbyists founds ways around putting stickers on all of our apples, oranges and carrots. In short, foods and products that may contain high amounts of heavy metals and contaminants may not have these stickers on them, leading the consumer to assume that they are relatively safe, while other companies who were probably sued into adding these stickers to their labeling may actually contain much less heavy metal contamination in their products than stickerless ones.
Prop 65 also included a clause that if a company has fewer than a certain amount of employees (around 10), they are not required to comply with this privately regulated sticker warning campaign.
In order for an herbal company to be compliant with Proposition 65 it has the following options: 1. Actually seek out herbs that have heavy metals within the allowable range; 2. Be able to prove that the metals contained in the herbs are not from industrial waste but are naturally occurring; 3. Place the embarrassing Proposition 65 warning sticker on the label; or 4. Not sell their products in the state of California.
The last option poses a dilemma because California has by far the largest consumer base for dietary and herbal supplements in the country. To choose to not distribute products in California risks a company losing significant market share.
What this means for the manufacturer is that they must be able to invest in expensive in-house testing equipment, hire and train employees, and test every new batch of herbs that comes into the company.
Even California's Attorney General has expressed disapproval with how this law is being abused but so far attempts to change it have failed. Imagine trying to pass a bill that would either exempt herbal companies from Proposition 65 or that would somehow raise the allowed percentage of heavy metals in herbs intended to be used in products.
The only positive thing this demonstrates is the quality based on the low content of heavy metals of compliant herbal products sold in California.
Why Supplements and Herbs Are Not Regulated Like Drugs
When some accuse the dietary and herbal supplement industry of being unregulated, what they really mean is that they are not regulated like drugs. Because this would be costly and impractical and ultimate mean that these products might no longer be available is the raison d'etre of DSHEA.
Following are five reasons herbs and dietary supplements are not regulated the way drugs are regulated:
1. Herbs exist in the public domain. To subject them to mandatory pharmaceutical-type regulations would remove the majority of herbal ingredients from the market. It is inconceivable to think of the hundreds, even thousands, of medicinal herbs and the decades it would take to subject each of these to the seven years of research and clinical trials on average that it takes before each of them could achieve legal drug status. During this time, these herbs presumably would not be available for use. It's a huge, unnecessary undertaking.
2. Herbs have a long history of safe use in contrast to pharmaceuticals, which are made from scratch in a lab, never existed before, and have no history of public use. Approximately a third of all pharmaceuticals are still derived or synthesized from plants. Pharmaceutical drugs seek to extract or synthesize only a single biochemical molecule out of thousands to create a drug. The concentration of a single extracted or synthesized chemical derived from a plant and given without the presence of the others has a different effect. Therefore these concentrated and isolated chemicals should be treated as a drug.
3. There is a large degree of safety with the majority of common herbal ingredients that are on the market relative to pharmaceuticals. There are only a very small number of herbs that are poisonous or toxic and these are infrequently used by herbalists these days.
4. No one will pay $750 million to prove chamomile is a good digestive aid.
5. Herbs do not pose the same risk as artificial hearts and should not be regulated in the same way.
The often-heard claim that the dietary and herbal supplement industry is unregulated is untrue. The more relevant claim that it is not regulated the same way as pharmaceutical drugs is true, the implications of imposing the same standards of regulation of drugs on dietary and herbal supplements seems unreasonable to say the least.
Finally, all people have the right to pursue whatever any avenue of healing they choose. The fundamental reason that there is a need for more than one approach to health and healing is because each has inherent limitations.
*Review of Ephedra and Heatstroke in Athletes
Bailes J, Cantu R, Day A. The neurosurgeon in sport: awareness of the risks of heatstroke and dietary supplements Neurosurgery. 2002;51(2):283-288. "The authors of this report blame the supposed 'deregulation' of dietary supplements under the 1994 Dietary Supplement Health and Education Act (DSHEA) for the increasing heat-related injuries among athletes. While acknowledging that '(m)ost recent heatstroke deaths have been in very large athletes who were starting their conditioning in very hot, humid conditions, sometimes in an attempt to lose weight,' they place much of the responsibility on 'a multibillion dollar industry that is subject to little or no government control or oversight with regard to the purity, consistency, potency, drug interaction, and potential side effects of its products.' The ability of the Food and Drug Administration (FDA) to ban products or ingredients which it finds hazardous and the history of FDA attempts to ban or limit sales of ephedra-containing products are not mentioned, and it is left to some of the professional and university level sports trainers and doctors who comment on this article to point out the responsibility of individual athletes to use reasonable caution in selecting dietary supplements."