The recently shelved New Dietary Ingredient (NDI) draft guidelines proposed by the FDA has been the subject of much concern by natural health supplement manufacturers and consumers ever since the announcement was made by the agency in early 2011.
The guidelines, which were published in the Federal Register, would have clarified some definitions of terms, changed requirements for “new” supplement introduction and manufacture, and a host of other more minor, but important, tweaks in previous FDA policy.
However, the most concerning aspect of the proposed changes is that many are actually the stealthy introduction of Codex Alimentarius-compliant regulations being imposed upon the United States health supplement industry. Specifically, these guidelines would not only have made it harder and more expensive for vitamin and mineral supplement manufacturers to introduce “new” supplements into the market, but it would also have resulted in the removal of many supplements from the market as it currently exists.
Most notably, the proposed FDA guidelines mandated the use of Risk Assessment methodology to determine and establish what could be easily described as the Maximum Upper Limit or Maximum Permitted Level of nutrients allowed in vitamin and mineral supplements – a hallmark of the Codex Alimentarius position in relation to these products.
If one is unfamiliar with Codex Alimentarius and the ramifications that the standards of this international organization will have on vitamin and mineral supplements in the United States (and every other nation), I encourage you to read my book, Codex Alimentarius – The End of Health Freedom, which is a comprehensive study of Codex Alimentarius and the fallout of adherence to the standards it sets.
In this context, it is extremely important to understand the deleterious effects of using Risk Assessment methodology in evaluating food supplements as well as establishing Maximum Upper Limits/Maximum Permitted Levels of nutrition in these products. Essentially, Codex Alimentarius derives its standards (which are set extremely low) by classifying nutrients as toxins even while classifying actual toxins such as fluoride as nutrients.
It is also important to understand that it is the goal of every nation that is part of the World Trade Organization (WTO) to become Codex-compliant for trade dispute purposes. Thus, it is easy to see why regulatory agencies such as the FDA, USDA, and EPA (which openly desires to become Codex compliant) introduce Codex guidelines through stealth and under the appearance of their own independent regulatory standards and volition. As I wrote in my article, “The Language of Health Tyranny: Decoding the Codex Alimentarius Guidelines For Vitamins and Supplements,”
Risk assessment, while seemingly benign, is actually crucial to the ability of Codex to justify the ban of vitamin and mineral supplements. This concept works on the assumption that the item being tested is inherently dangerous and toxic. This method is completely the opposite of what should be used when evaluating vitamins and minerals. As Dr. Rima Laibow states in her article “‘Nutraceuticide’ and Codex Alimentarius:”
This use of risk assessment, of course, represents a major deflection from the real use and value of risk assessment, which is to make sure that people are not exposed to the dangerous industrial chemicals that have serious and sometimes lethal effects on them and their children.
By applying “scientific risk assessment” to nutrients and supplements, they are essentially considering them toxins as they are lumped into the same category as chemicals and poisons. There is no need to explicitly state that “nutrients are toxins.” This is done by default. So, in the end, we have the categorization of vitamins and minerals that are essential to human health and life as something that is actually toxic. In this sense, we are entering the world of doublethink.
Regardless, this is the position of Codex, as well as the position of the U.S. Delegation throughout the discussion [Codex Committee on Nutrition and Foods For Special Dietary Uses]. Indeed, even many alleged “health freedom” International Non-Governmental Organizations were either gullible enough to be taken in by the promise of the benefits of risk assessment, or morally bankrupt enough to be bought off by the pharmaceutical industry or others who might benefit from the demise of the natural supplement industry. Yet, some of the support for risk assessment methods early on seems to have been based on the fear of the implementation of maximum limits proposed by European countries like France. These limits would have reduced the potency level of each pill to no more than 15% Recommended Daily Intake (RDI), a figure that is already set much too low. Yet those who favored risk assessment seemed to jump from the frying pan into the fire. As Scott Tips of the Natural Health Federation writes:
The so-called ‘science-based risk assessment’ for establishing Safe Upper Limits (maximum levels) for vitamin-and-mineral potencies, to which the EU has agreed, and about which the Americans are as happy as flies on cow dung, is nothing but a trap. The Americans think that they will be able to get real science to establish high maximum levels for their vitamins and minerals and then sell them to European consumers by the bushels. But by the time the Europeans get through applying their science, those maximum limits will be so low toddlers would be lucky to get any nutritional value out of Codex-harmonized vitamins and minerals. The European Union’s Scientific Committee on Food has already started using its science-based risk assessment to establish laughably low maximum limits for European vitamins. And, lately, I have begun to see a growing concern, if not outright fear, in the faces of some science-based risk-assessment proponents that perhaps things might not go their way here after all.
With this in mind, the FDA’s NDI draft guidance document would have required the supplement manufacturer to include an NDI notification for the “new ingredient.” Among the requirements of the notification is the establishment of a “No-Observed-Adverse-Effect Level” (NOAEL) as well as the Acceptable Daily Intake (ADI) for the ingredient. While the ADIs present their own controversy (always being set too low), the NOAEL is, in fact, simply another name for Maximum Upper Limits/Upper Safe Levels – a level which affects the actual production and consumption of the supplement as opposed to the instructional element.
These levels, while seemingly benign or even positive constructions, are far from helpful when applied to nutritional supplements. To give an idea of how these Risk Assessment numbers are improperly applied and then ratcheted down until the supplements are rendered virtually useless, Rima Laibow describes the Risk Assessment methodology as follows:
First a group of test animals, mice, rats, rabbits, et cetera, are increasing amounts of the toxin of interest. The dose in increased until half of the animals are dead. The dose at which 50 percent of the test animals die is called the Lethal Dose 50 (LD50). A similar dose is extrapolated for humans.
Next, the other end of the dose spectrum is investigated by giving test animals smaller and smaller doses until no impact can be identified from the dose of the toxin to establish the Maximum Upper Limit (MUL). The MUL is divided by a safety factor, typically 100. The dosage that results is called the Maximum Permissible Upper Limit.
When the “toxin” is actually a nutrient, setting the MUL at a point where there is no impact is defeated the purpose of consuming the nutrient in the first place, as well as the precursor to significantly raising the costs and practicality of obtaining proper nutrition.
Thus, the FDA’s draft NDI guidelines as previously submitted were infested with Codex Alimentarius-based guidelines of Risk Assessment and Maximum Upper Limits/Upper Safe Levels designed to reduce access and availability of nutritional supplements both from the shelves and the factory.
Of course, these specific guidelines were not the only way in which the FDA had attempted to impede the development and production of nutritional supplements. The NDI guidelines also attempted to make NDI submission supplement-specific as opposed to ingredient-specific. This means that the agency would have required a new NDI notification for each specific supplement, formula, or blend in which the NDI is used, instead of simply the NDI itself. That is, unless the manufacturer is able to meet some rather strict criteria which, among other things, conveniently reduce the amount of the NDI in the supplement.
Certain types of probiotics would also have been restricted given the FDA’s attempt to exclude the designation of the bacteria supplement as being a dietary ingredient – thus potentially removing certain amounts of probiotics from the market.
Thankfully, for the time being, the FDA’s guidelines have been postponed after significant public outcry and a meeting with a handful of senators and representatives in the U.S. Congress. However, the guidelines will be revisited in the future and one can only guess as to what they may include when the updated versions are released to the public.
Keeping history in perspective, it is an unfortunate reality that government revisions often make the original bill seem better in retrospect. This is because they can count on the second round of opposition to only be half the size of the first. Thus, after a bit of rewriting and rewording, the new version of the bill or policy often includes elements which were even worse than the first version due to the fractured resistance it will now encounter.