By Steve Mister Esq., President and CEO
"This guy is falling; this guy is falling!" And so Chicken Little's efforts to save a man who was about to tumble off a balcony became immortalized as the classic overreaction. When Lucy Goosey and all the other animals thought they heard "the sky is falling," poor Chicken Little became the butt of endless ridicule. And all because the rest of the farm misunderstood the nature of the danger and failed to comprehend the implications of their scorn of Chicken Little.
And so it is with reaction to Codex.
Codex Alimentarius, as it is officially known, is Latin for "food book" and is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. The Codex Commission was established in 1963 by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The Commission's main purposes are to protect the health of consumers and ensure fair practices in the international food trade.The Codex Alimentarius is recognized by the World Trade Organization as an international reference point for the resolution of disputes concerning food safety and consumer protection.
In reality, what Codex means for U.S. manufacturers is that where there is a Codex standard, a foreign government cannot deny entry to that food product (including dietary supplements) based on a supposed safety concern if the product meets Codex standards. In that way, it protects U.S. companies trying to export our supplements to other parts of the world.
The Codex standards can be thought of as setting maximum trade restrictions that a country can impose on the basis of safety. If the product meets those standards, whether it is imported or domestically produced, the country can't deny entry. Refusing to do so would permit the exporting country to cry "foul" (or should I say "fowl?") as a violation of international trade laws.
Somehow, these standards got misunderstood as setting minimum requirements for food. And the Codex critics allege that a government would be required to regulate their domestic products to the level of Codex standards. That's absolutely false. Nothing in Codex encourages or requires participating countries to adopt those standards for their internal regulation. Really? Yes, really.
Codex interpreted over time
Over the past 10 years, the word "codex" has been a lightning rod for various groups who have warned of "world government," U.S. abdication of its constitutional values and the death of the dietary supplement industry across the globe. In 2006, in an effort to prevent the Codex Guideline for Vitamin & Mineral Food Supplements from being adopted, critics charged that if it was approved, the supplement industry in this country would be destroyed in a matter of weeks FDA would be reaching into our medicine cabinets and removing our vitamins. It passed in 2007 with no effect on domestic markets. Really? Really!
Most recently, the anti-Codex folks have attacked the new food safety law for allegedly unleashing the Codex beast. They successfully strong-armed Congress into inserting a provision into the law and proclaimed that they had saved this country from ruin. Let's look at the facts. Part of the law charges the Secretary of Health and Human Services with developing a comprehensive plan to expand the capacity of foreign governments and their respective food industries which export products to the U.S. to share their data electronically with the FDA to develop methods by which FDA could recognize those countries' inspections, and to train those agencies on the U.S. requirements for food safety. Otherwise, FDA would have to send its own agents into every food plant worldwide to inspect the facilities to U.S. standards. The plan would make recommendations "on whether and how to harmonize requirements under the Codex Alimentarius." In other words, where there are opportunities to hold other countries to at least the Codex standards, FDA should do so, not the other way around.
Nevertheless, the mere mention of Codex drove well-instructed, but perhaps misinformed, consumers into the halls of Congress demanding that this section of the law include the statement, "Nothing in this section shall be construed to affect the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994." Really? Really. But the truth is that there never was anything in the bill now law that would have been construed to affect dietary supplements regulation. The "sky is falling" mentality overwhelmed thoughtful analysis of the provision.
Here's another example: our anti-Codex friends are now opposing the creation of maximum levels of nutrients that may be sold under the international food standards. Codex is creating scientifically based standards for how potent (or even super-potent) vitamins and minerals may be and still be sold as "food" as opposed to "drugs." Written into these standards are requirements that the upper levels must be risk-based, use proper evidence that examines human data and be as high as the data will permit. They replace RDA-based upper limits with ones grounded in real science; usually resulting in much higher potency levels which can be sold internationally than would have been allowed otherwise.
Effect on the U.S. market
In the absence of this standard, a country could deny entry to U.S.-manufactured vitamins and minerals using non-scientific, politically-rooted justifications by saying that their potency was unsafe and violates that country's safety standard. One can look at Germany's recent attempt to restrict vitamin B12 products to three times the RDA level (9 mcg), or France's effort to limit B12to one times the RDA (only 3 mcg). An imported product that contained more than those levels of vitamin B12 could be denied entry and be required to be sold in that country as a drug instead.
Left to their own devices, the group of Southeast Asian nations currently harmonizing their laws could easily adopt unscientific upper levels that would close those markets to U.S. products. Nothing in these Codex standards would impose a maximum level on FDA if the data here justifies a higher potency. Rather, these maximums will keep Germany, France, Southeast Asia (and even the U.S.), from imposing a lower limit than the international standard allows.
So how did we get to this point of confusion and hysteria? I think, like Chicken Little's friends, many people misheard the original message. Now, many of this industry's best consumers and staunchest allies on other issues of supplement regulation are well-meaning, but misinformed and trained to react negatively at the utterance of "Codex" without asking critical questions. It's time we paused and examined the facts.
There's this guy who owns a small supplement business who desperately wants to expand into foreign markets to grow his company and offer consumers around the world the health benefits of his products. Other countries would push him off the ledge to protect their domestic markets. This guy is falling, and Codex could be the thing that saves him. If you misheard the warning and thought the sky is falling instead, maybe it's time to re-listen to the message.
(The CRN Blog represents the view of the author and does not necessarily reflect the view of CRN's Board of Directors or serve as an official position of the association.)