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This Week in FDA Regulation: Celiac Disease and More Power!

By William Peacock, Esq. on August 08, 2013 | Last updated on March 21, 2019

Man, it must be unspeakably awful to suffer from Celiac disease. To never taste the majesty of a buttered croissant, or to have to worry about whether one's beer is going to cause distressing intestinal pain, is a terribly depressing thought. Imagine then, picking up a product labeled "gluten free" and then discovering, the hard way, that the label was "inaccurate" or "exaggerated."

That shouldn't happen anymore, or at least after this year, per a new FDA labeling regulation. Beyond waging war on wheat-sneakers, there have been calls for the FDA to reach into two other previously unexplored (or loosely regulated) areas: compounding pharmacies and dietary supplements.

So once more for you food-industry GC's, regulation wonks, or the merely curious, here is a run-down of some of the latest in FDA regs.

Wheat Sneak

A label means nothing until it is regulated by the government. Remember when every company was labeling everything as "organic," including bottles of water?

You (probably) won't suffer greatly if you buy a mislabeled bottle of organic water. For the estimated 3 million Americans suffering from Celiac disease, buying a mislabeled "gluten-free" product can have painful consequences.

Help is on the way. Per a new FDA regulation, which takes effect on Aug. 5, 2014, products labeled "gluten free," "no gluten," "without gluten" or "free of gluten" must contain less than 20 parts per million of the substance.

Compounding Pharmacies

Last year, a batch of contaminated spinal injections, made by a compounding pharmacy, sickened more than 700 people and killed 63 others. The Government Accountability Office, earlier this week, released a report detailing the problems that led to those deaths, reports the Kansas City Star.

The biggest issue is the grey area of regulating compounding pharmacies. These businesses mix drugs into custom dosages and delivery mediums (such as pain medication lozenges). Currently, oversight falls somewhere between state governments and the FDA.

The GAO report merely outlines the factors that led to the problem. The solution may be in clarifying the FDA's authority to regulate pharmacies that compound substances destined for patents in other states.

Supplementing Supplement Labels

Want a trimmer waist, or better memory, or heck, bigger ... pecs? Somewhere, there is a nutritional supplement that promises just that. Most of us jaded, cynical lawyers are aware that most nutritional supplements' claims are, at a minimum, exaggerated. But not everyone is blessed with a heart of stone and a skeptic's soul.

U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) introduced legislation last week that would, among other things, require honest labeling, enable FDA oversight, and would require the companies to prove those "immense growth" claims.

The legislation would go a long way towards curbing incidents like the alleged 5 Hour Energy-induced spontaneous abortion, or a personal favorite, energy drinks reclassifying themselves as supplements to avoid regulations.

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