Labeling Redux

Dear Reader,

I spoke with Maria at Source Naturals and learned that the labeling change reflects not a change in ingredients but a change in law. The Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282) went into effect January 1st of this year and is being enforced by the U.S. Food and Drug Administration (FDA). It increases the strictness of the rules governing labeling of the top eight ellergens in food and supplements, but unfortunately the wording is vague enough to be too strict.

The law is intended to ensure that even subtle amounts of allergens in products are listed, such as might result if an ingredient is not actually present in the product but was present in the factory where the product was produced, but the law as written requires exactly the same wording as if the product contained that ingredient. For example, Wellness Formula contains no dairy or soy, but some of the ingredients come from machinery that is also used at other times to process dairy or soy. Under the new law, Source Naturals is required to say their product does in fact contain those ingredients, even though it probably does not and if it does it contains at most trace amounts by accident. Prior to this law, there was a common wording used for such situations, namely "processed on machinery also used to process dairy and soy," which it would have been good to require Source Naturals to add, but instead the new law requires them to use this wording: "Contains milk/dairy and soy." The required wording is probably false, or at least false most of the time, but they are required by law to use it.

In such clumsy ways are the good intentions behind laws perverted in their execution.

The good news for me is that since the FDA-required label is false, since Wellness Formula contains at most trace amounts of dairy, I can continue to use it. Likewise, I can hold Source Naturals blameless for the confusing labeling and place responsibility where it belongs, with the drafters of this new law.

As you may know, the FDA's soul is split between protecting consumers and protecting the profits of the drug companies, and the agency has been responsible for some more or less corrupt activites, such as protecting the poisonous sweetener Aspartame by banning the marketing of the healthy natural alternative Stevia as a sweetener. FDA has lately been serving its drug company clients by trying to whip up an atmosphere of public fear of vitamins, supplements, and other alternative medicine products, thereby supporting lobbying efforts to "regulate" (i.e., restrict access to or put out of business any companies that sell) these alternatives to patentable drugs. Given this background, it is reasonable to wonder whether the FDA will enforce this law unevenly, using it as a club to put more pressure on the purveyors of alternative medicine. Certainly companies like Source Naturals have to be prepared for that and ensure that they adhere to the strictest interpretation possible of this ambiguous new law, if they want to avoid the product seizures and punitive fines FDA can levy.

To have at least part of the FDA so in the pocket of drug companies is Orwellian, since the organization is theoretically charged with protecting the public. Having worked for so many years for the federal government, I know no agency is monolithic, and the FDA will still have many career employees thoroughly dedicated to its original mission, employees who will be the first to acknowledge that some in the upper layers of their organization's management will be the usual rotating political appointees who are there to ensure the agency's primary mission does not interfere with the interests of the administration's political clients. The outcomes, good and bad, from any U.S. government agency tend to take their shape primarily from such tugs of war between these two populations of employees--those there to serve the mission and those there to serve their political masters. Where the former predominate, usually by accident or oversight, the occasional great government program can result, but usually the results more resemble this FDA law in their hamartia, missing the mark, in subtle but important ways.

Yours truly,
Rick

Postscript: For more information on the new labeling law, an article in Natural Products Insider gives a brief overview.