Celiacs and Gluten Free folks around the country rejoiced this week when the FDA finally defined rules for the term “Gluten Free” under petition.
This past week, the Federal Food and Drug Administration released official guidelines to regulate the use of the term “Gluten Free” on strictly voluntary labels on foods and drugs regulated by the FDA.
Will this lead to more problems than it solves?
A reliable source in the gluten free community points out that blind belief in labels is dangerous.
“The idea of a product being mis-branded in today’s day and age is commonplace and rampant. There is hardly any policing, and this can lead to bigger issues when it comes to your health,” says this well known doctor who asked to remain unnamed.
The same cat and mouse game played between manufacturers and the government with all labels, will most certainly exist with this labeling law too.
The big problem boils down to rule routing and enforcement. As with all FDA Label Laws, it’s all on the honor system and the fear among industry thought leaders is that this will lead to mislabeled products, and ultimately rampant “glutening” through “misplaced faith in a broken system.”
Let’s consider some talking points.
1) The FDA rule does not apply to any foods that are not regulated by the FDA, and imports are rarely checked.
2) The rule makes no requirement for gluten testing of products on store shelves.
3) The rule does not cover cosmetics, unregulated supplements, drugs, and other personal care products.
4) The rule does not define any advertising, promotional materials or web sites.
5) The rule is very vague on the matter of cross contamination.
6) The rule doesn’t apply to restaurants in the same way.
Let’s also consider how mis-labeling is handled.
The FDA’s enforcement arm is generally involved only if a specific number of people are seriously injured in a specific, short time frame. To make matters worse, in the world of Celiac, it’s possible to argue that contamination was entered at any point beyond the rule’s definition, such as a consumer accidentally ingesting gluten from a different source.
As with all FDA Labeling laws, there is a complaint system in place, however it could be very difficult to prove validity of complaints.
Further, in order for the FDA to do anything about a mislabeled product, it must first make a determination that mislabeling has occurred. This is a lengthy and tax expensive process that can take several years provided no death has occurred.
The process goes a little something like this.
1) Complaints are collected.
2) If complaints regarding a product pile up, the FDA will send the company a letter notifying them of the complaints, probably with a small threat for a reply.
3) If the FDA is satisfied with the response, the buck stops there, possibly with a warning issued.
4) If complaints continue to pour in and the FDA decides to investigate, they now have the burden of proof on their shoulders.
5) The FDA will purchase the product from a specific number of sample sites (stores around the country) and they will test the product themselves.
6) If the product is deemed misbranded, they will again contact the company and request voluntary action from the maker. Such as issuing a statement, changing practices, offering refunds and the like. This could possibly come along with a small fine, but not always.
7) The FDA still has no right to pull products from store shelves. In order to do this, the FDA must go to Federal court and PROVE that any product causes immediate grave bodily harm or death, a process that can take years.
With The FDA under fire this year, having misbranded cases vacated by the 2nd Circuit courts in 2013 and a $3 Billion Dollar penalty imposed by the FDA tossed right out of the window. It was aptly said to be “death knell for label enforcement” as the legal underpinnings were called into serious question.
With multiple legal and civil lawsuits in the “billions of dollars” range, it might be tough to call further attention to any gluten-free issues.
In the meantime, one mislabeled gluten free product could have adverse effects on thousands of people country wide.
As one of the gluten-free thought leaders in the United States, I personally would encourage you to continue to investigate products and companies alike on your own, and use your very best judgement skills that you have already developed. We all know that once Big Corporate thinks they have you in a comfortable spot of faith in the system, they can begin to wildly abuse it.
The companies that are “doing it right” currently, will of course remain the ones “doing it right” in the future.
And this is in no way a bash at the FDA, they did EXACTLY what you have been asking for.
The question is, what door does this open for the Monsanto’s of the world??
What do YOU think? Was this rule it into place just to placate those of use fighting for true regulatory action, or does it truly fix all the labeling problems??