Rights & Responsibilities

In assuring access to dietary supplements, many of us rely upon them as an out-of-pocket expense. So far in the United States, they remain available without regulation (with some notable exceptions such as androstenedione). However, many individuals and organizations have expressed concern that the marketplace may be squelched by changes in international law that would either restrict the levels of vitamins and minerals in supplements or render botanicals and such unavailable.

This article attempts to tease out three DISTINCT issues that are sometimes conflated. These are the Food Safety Bill (S.510), Codex Alimentarius and the European Union’s Food Supplements Directive.

Recently, the American Association for Health Freedom (AAHF), an industry lobbying group that “works at the federal and state level to protect the right of the consumer to choose and the practitioner to practice,” recently sought input on a “Food Safety Bill” introduced into the Senate as bill S.510. A version of this bill has already passed the House.

In general, the bill appears to be a best effort to address some of the problems in Agribusiness that have resulted in contamination of foods by infectious agents, e.g., E. coli and salmonella outbreaks in the past few years. These have caused some deaths and widespread illness. The bill is designed to expand FDA’s power and obligation to assess foods, both domestic and imported. It sets up parameters for inspections of domestic and imported foods, creates around 4,000 new inspector jobs per year, provides funding (about $870 million) and in general, gives FDA the tools to inspect, evaluate threats and respond with some vigor. These, in principle, are all fairly good things, from a consumer perspective.

There are some elements of the bill that are of concern. For AAHF, the concerns are that the fines and potential prison terms that ostensibly may be imposed will have little impact on larger industry while being potentially devastating to smaller businesses. According to a brief from the Dickinson School of Law from Penn State, the delineation of fees as well as criminal and civil penalties would appear to have little impact on major corporate businesses but a severe and debilitating effect on small farmers. The maximum penalty for an individual farmer is $50,000, whereas the maximum for partnerships, corporations and associations is $1 million—a rather paltry sum for some of the larger corporations (e.g., Monsanto). Thus, this appears to be a legitimate criticism that may better be addressed by the use of percentages. However, it appears clear that some of these concerns have been addressed as a recent Washington Post article makes clear, stating Agriculture interests were able to win key concessions. Small farms are exempt from registration fees, ranchers and farmers now regulated by the Agriculture Department are excluded from the requirements of the bill and the FDA will have to consider the special concerns of small growers and organic farmers, among other provisions.

The other issue that arises from this bill is the specter of the Codex Alimentarius. This Latin term, which means “food code”, is a set of laws, regulations and recommendations set up by the World Health Organization, a body of the United Nations. It was developed from a Commission that was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations. Thus, the major focus of this set of regulations has to do primarily with foods, importation and exportation, quality control standards, and the like.

In the S.510 bill, the Codex is mentioned once in Section 306(c)(5) states: Recommendations to harmonize requirements under the Codex Alimentarius. This is a vague statement with uncertain implications. The major concern with these set of regulations boils down to whether it will adversely impact our right to access dietary supplements. Recall that dietary supplements, a term developed in the United States, are not considered either food or drugs. These include vitamins, minerals, amino acids, thousands of different botanicals (“herbs”), protein powders, hormones, etc.

Unfortunately, on the internet, there are a wide variety of commentaries, many of which contain inaccurate information, sometimes verging on hysteria. However, the good news is that it probably will have NO effect upon access to dietary supplements. As you’ll see though, due to the peculiarities of so-called “free trade” agreements among the Americas (notably, CAFTA), we may not be entirely out of the woods (see below).

First, though, it is important to recognize the European Union’s Food Supplement Directive, which will go into effect on 12/31/09. This may have a deleterious effect on access to supplements among our friends in Europe! There is strong resistance to this rule which many feel will harm the health and lives of Europeans through draconian establishment of low “upper limits” for vitamins and minerals. This rule, however, is distinct from the U.S. and should not be confused with the Codex. We hope to explore this issue from the perspective of our friends in Europe in the near future. Meantime, for a review, click on this sentence.

The point is though that the restrictions seen in this legislation are not apparent in the Codex. The two should not be confused, nor does this represent a particular threat to supplement access in the United States.

One of the major concerns with Codex is the notion of harmonization, wherein all member nations would have to harmonize their laws to match those of the Codex. This is of particular concern to users of dietary supplements as some of the European laws are extremely restrictive. (This in some cases may be due to their use in prescriptions that are part of national healthcare programs unavailable in the United States.) For example, levels of some vitamins are restricted to quantities per tablet of perhaps only a few times the U.S. Recommended Daily Allowance (RDA) or, more recently, Dietary Reference Intakes. The RDA is generally what is needed on a daily basis to avoid illness that arises from an outright deficiency.

Even within the United States, these have changed considerably. However, as these levels are only to prevent deficiency diseases, they do not preclude the use of higher dosage that are with ranges of the No Observed Adverse Event Level (NOAEL) or Lowest Observed Adverse Event Level (LOAEL). However, it appears that even the more conservative NOAEL suggests daily intake levels that are far above what is permissible to be sold over-the-counter in several European countries.

Of course, very high doses of anything can be potentially toxic. The most pertinent example is the mineral selenium. Doses approaching 1 mg (910 mcg) or more can be toxic and too much (probably over 2,000 mg) can be fatal. (Aside: While it may not be a proven remedy, I would consider NAC as a therapy to offset selenium or other chromic toxicity.) So care should be taken so that accidents are avoided. Infants and children also face different levels of risk. However, following guidelines on the use of dietary supplements shows they are extremely safe (and far safer than prescribed or over-the-counter drugs). It would seem that the potential dangers are used by some to invoke fear mongering more than rational policy.

The larger concern with harmonization arises as a result of recent “free trade” agreements that the United States has forged with other nations in the western hemisphere. These include Central American Free Trade Agreement (CAFTA) and the North American Free Trade Agreement (NAFTA). If more restrictive laws toward dietary supplements in member nations of these agreements hold sway, the U.S. may be required to harmonize with the laws of, say, a central American nation. Of even greater concern is the Free Trade Area of the Americas (FTAA), which would create a harmonized pan-American trading bloc encompassing the entire American continent.

Somewhere in this mix, the voice of consumers must be heard. Not just the interests of those selling vitamins nor those who perceive them as a threat to selling drugs—but those of us who use them to manage chronic diseases and simply to live a healthier life. And for the many millions more who may benefit from their use but cannot afford them!

At the end of the day, vigilance will be important. Assuring access to the benefits of dietary supplements to ALL who need them should be the goal of both good medicine and robust public policy.


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