Meetings being held between the National Academy of Sciences (NAS) and other world bodies to discuss “harmonization” (meaning restriction) of “nutrient intake” recommendations indicate that the answer may be yes. Action Alert!
NAS, which is a United States non-governmental organization that advises the federal government on a range of issues, recently met with groups from the World Health Organization and the United Nations, both of which are sponsors of Codex, a long time threat to US supplements, to discuss possible supplement restrictions under the guise of facilitating trade.
Severe restrictions on vitamin doses in supplements are already well under way in the European Union, and it doesn’t look good. At one point, the European Food Safety Authority (EFSA) discussed setting the maximum level for beta carotene in a supplement to the amount provided by half a carrot, and the maximum level of selenium to what is found in one-third of a brazil nut.
EFSA could arrive at such nonsensical conclusions only through bad science, as our scientific director Rob Verkerk has demonstrated. The methods they used originated from concerns about environmental toxins, which of course have no beneficial role in health. Nutrients are quite distinct, and as such, require a completely different approach. For example, their analysis failed to break down a nutrient group; instead EFSA set a maximum level based on the most hazardous (and usually synthetic) member of a given nutrient group such as vitamin A (retinol /natural b-carotene), or iron (iron sulphate /ferrous bisglycinate). These methods obviously yield skewed results and did not take into account variations in the population (age, race, genetics, etc.) that affect the amount of nutrients one might need.
The dose limiting in Europe, while bad for Europeans seeking to optimize health through therapeutic levels of nutrients, normally wouldn’t be an immediate cause for concern for those of us in the United States. This is where Codex Alimentarius comes in. Codex was initially developed as an intergovernmental body to establish international food safety standards and regulate ingredients of food products with the stated goal of promoting “fair trade practices” and consumer protections in the global trade for food. A country does not have to adopt Codex standards, but approximately 300 Codex guidelines and standards are used by its member countries (which include the US) as the basis for their regional and national laws.
Codex standards regarding supplements are widely expected to follow EFSA and the EU’s lead, since the EU has considerable influence in Codex. A few years ago, there was great concern that the US, a member of Codex, would adopt these restrictive standards behind closed doors without public involvement. If the FDA follows the law, however, this shouldn’t be the case. Adopting international standards should be a public process, either through a comment-rulemaking procedure or through the creation of legislation in Congress. Either way, the public should have an opportunity to weigh in.
The larger question of whether the FDA can ban high-dose supplements without public involvement, though, is less black and white. Our concern is that the question is no longer whether the US might try to adopt Codex standards, but whether it will follow the EU’s lead and create standards, including upper limits, on its own.
Federal law defines an adulterated supplement as a supplement that “presents a significant or unreasonable risk of illness or injury” either when used according to the product’s label or under ordinary conditions of use. Recently, the FDA determined through a guidance document that certain bulk caffeine products were adulterated because they contained hundreds of potentially lethal doses. The FDA said that these products must either be diluted or sold in pre-measured packets. This is important in as much as the FDA made a determination through guidance, rather than rulemaking, about what an “adulterated” supplement is—and the FDA cannot be legally challenged for positions taken in a guidance. Might the FDA point to NAS recommended upper limits on vitamins to turn around and say that any supplements containing doses above those levels are “adulterated” because they “present a significant or unreasonable risk of illness or injury”? It’s unclear, but this concerning avenue seems open.
The involvement of the NAS appears to mark the initial phase of bringing the discussion of establishing upper limits for vitamins to the US. Codex is in large part a project of the World Health Organization and the Food and Agriculture Organization of the United Nations—two of the other groups present at the NAS’s workshop, in addition to representatives from EFSA. These are not good signs and suggest the US, too, may follow the flawed European approach to setting limits on vitamins.
It also should be mentioned that, irrespective of influence from Europe and other world bodies, the National Academies of Science, formerly known as the Institute of Medicine, has proven definitively that, when it comes to supplements, it has no idea what it’s talking about. For example, the organization’s recommended daily allowance for vitamin D is a paltry 600 IU for adults; it’s upper level—that is, the level above which the organization said poses a danger to the individual—is 4,000 IU for adults. The Vitamin D Council, on the other hand, recommends 5,000 IU of vitamin D for adults, and other estimates are even higher. Put simply, we do not want the NAS anywhere near a discussion that could lead to limits on the levels of nutrients a supplement can contain.
We cannot wait for these discussions to take a more concrete form to take action. We need to stop the NAS in their tracks now.
Action Alert! Write to Congress, the FDA, and NAS and ask them not to allow the National Academy of Sciences (NAS) to engineer severe upper limits on supplement doses along the lines set by the EU and world body Codex. Please send your message immediately.