Amy Burkhart, MD, RD

Amy Burkhart, MD, RD

Amy Burkhart, MD, RD, is a board-certified emergency medicine physician and registered dietitian. She also trained in integrative medicine with Dr. Andrew Weil at the University of Arizona Center for Integrative Medicine. Her practice is located in Napa, CA.
1100 Lincoln Ave. Suite 200
Napa, CA 94558
(707) 927-5622 Office
What do gluten-free labels and caution statements on packaged products really mean?  Should you pay attention to warnings such as “made in a shared facility” or are they simply legal jargon? Data from a new study by the FDA, which analyzed the gluten content of 461 packaged products, may help answer these questions.16467121_s

The gluten-free labeling rule officially went into effect August 4, 2014. The labeling rule obligates manufacturers who voluntarily label their product “gluten-free” to ensure that the product contains less than 20 ppm of gluten. This level is the amount of gluten deemed safe for people with celiac disease, an autoimmune condition activated by ingesting minute amounts of gluten.

But people who must avoid gluten for medical reasons still question whether products are truly gluten-free as labeled, and are confused by a variety of ambiguous labeling practices. Terms such as “no gluten ingredients “and “made without gluten” are now frequently seen on products.  Advisory warnings such as “made on shared equipment” or “made in a shared facility” are common. What do these really mean and how seriously should you consider them?

1. Are foods labeled “gluten-free” actually gluten free?

There are very few studies that address this question, but a recent market survey by researchers at the FDA’s Center for Food Safety and Applied Nutrition attempted to quantify the risk. The study will be published in the February 2015 issue of the journal Food Chemistry (available online now) and was the subject of an article in Food Navigator.  I am very encouraged that the FDA is committing the resources to study food safety for consumers who are on a gluten-free diet for medical reasons.

The FDA researchers evaluated 275 different foods that were labeled gluten free by testing them for the presence of gluten. Their results were encouraging. Only three out of 275 products contained more than 20 ppm of gluten (1.1%). Based on these numbers it appears that manufacturers are doing a very good job of ensuring their gluten-free labeled foods are actually gluten-free. Of the three products that were misbranded (contained more than 20 ppm gluten), my hope is that the FDA is following up with those companies to correct the issue.

Take home point: Manufacturers are doing a very good job of ensuring that products labeled “gluten-free “ are safely below 20 ppm.

2. If food is not labeled gluten-free, can you rely on the ingredient list?

If a packaged food is not labeled gluten free, yet the ingredients appear to be gluten free, what are the chances it may contain gluten? Gluten can be accidentally introduced into a product through cross contamination which can occur during production, preparation, transportation or storage of ingredients and food products. Gluten from cross contamination may be enough to cause illness in someone with celiac disease, wheat allergy or gluten sensitivity. But, how often does this really happen? Can you rely on simply reading the ingredient list?

The FDA study analyzed whether consumers could rely on reading the ingredient list if a food was not labeled “gluten-free.”They evaluated 186 foods that appeared to have no gluten ingredients but were not labeled gluten free.  Unfortunately, they inexplicably included products containing oats. It has long been known that oats, while inherently gluten free, are frequently cross contaminated with gluten. This is so well known, in fact, that there are a number of companies that specialize in producing certified gluten-free oats that are specially grown, harvested and packaged to prevent contact with gluten.

In the results, the FDA study states that 19.6% of unlabeled foods with no gluten in the ingredients contained unacceptable levels of gluten. But when we take oats out of the equation, only 4% of these products contained gluten.

Take home point: If the ingredients appeared gluten free, and did not contain oats, 4% had unacceptable amounts of gluten. Thats a pretty small number, so the risk if fairly low, but it would be wise to inquire about manufacturing procedures, especially on products you consume regularly.

3. How do you interpret a label that contains a warning or advisory statement?

The FDA study found that if a food contained an advisory label such as “made on shared equipment,” 43% of the products contained unacceptable levels of gluten. Again, if we take out products containing oats, we are left with only four products to evaluate that contained an advisory label. This is hardly a large enough sample on which to base a recommendation. On this point, further evaluation is needed and common sense taken into account until we have more data. If the risk of cross contamination is high, such as in a shared facility or production line for baked goods, it would be wise to avoid these products. The risk may be lower for non-bakery products, where there is no aerosolized gluten, but it depends on many different factors at the production facility.

Gluten-free shoppers often assume that advisory warnings on labels are used to protect the company from a legal standpoint and are not related to actual risk for the consumer. While in some cases this may be true, many companies are doing it to maintain transparency and protect the consumer from real risk. When possible, it is best to contact the manufacturer to clarify the risk if it’s not clear. There are many safe gluten-free alternatives today and countless naturally gluten-free foods available.  Hopefully other options will be available if a warning cannot be clarified.

Take home points: Advisory labels are meant to be taken seriously. Each product must be considered individually. It is best to contact the manufacturer for additional information if necessary. 

4. What if the product is labeled “gluten-free,” but contains oats?

To comply with the labeling regulation, if the product contains a gluten-free claim at all, it must contain less than 20 ppm of gluten.

Take home point: These products should be safe.

5. What about “no-gluten ingredients “or “made without gluten ingredients”?

These phrases are unfortunate loopholes in the labeling rule and are now seen on many packages. These terms do not need to adhere to the labeling regulations so their meaning is vague. The FDA in this study did not evaluate products with these claims, but it is my hope that they or someone else will do so soon. Contacting the manufacturer for products with these claims is recommended.

It is reasonable to assume that there is a substantive reason that these products are not labeled gluten free. It’s a valuable selling point if a product is labeled gluten-free, so it should raise suspicion if the company is deliberately using a similar-sounding term that evades regulation. Perhaps they are made in a shared facility or the ingredients are not sourced from gluten-free manufacturers. If the manufacturer cannot clarify the situation to your satisfaction, it would be prudent to avoid these products.

Take home point: These products should be avoided if the manufacturer cannot adequately explain why they are not using a regular gluten-free label.

Fresh, whole food is still best

I am grateful for all the efforts put forth by the people who have spent countless hours to make the gluten-free labeling rule a reality. There is more progress to be made, but we should all appreciate the work that has been done to make gluten-free packaged foods safe. However, we should remember that the healthiest foods are naturally gluten free and have no packaging. Packaged foods should be a supplement to a diet that is based on whole, fresh foods. Fruits, vegetables and many other unprocessed foods are naturally gluten free and carry benefits for you beyond the absence of gluten.