Labeling Laws: How Much Gluten is Safe to Eat?

Since the FDA re-opened the comment period on the 2007 proposed rules for gluten-free labeling, the question on everyone's mind is, "Is the allowed 20 ppm really safe?"  According to The University of Maryland's Center for Celiac Research, the safety limit ceilings out at 10 mg.  This allows quite a large amount of gluten-free labeled foods that contain the FDA's recommended allowable amount of 20 ppm during processing.  In plain English, 20 ppm allows most people with celiac disease to eat 18 slices of gluten-free bread or 9 servings of gluten-free pasta before they reach the limit of 10 mg of gluten in your food.  The Center for Celiac Research has also been studying the rise of gluten intolerances.  In addition to the 1 in 133 people with celiac disease, there are more than 18 million people have gluten sensitivities which range from mild to severe reactions. 

Read more specifics on The Center for Celiac Research's guidelines.

Lend your voice to the comments on the FDA's website

Read The Center for Celiac Research's initial reaction to the proposed law.

Excerpt:

“This standard has been in use in Europe for almost two decades,” says Fasano, “and the science supports its adoption in the U.S.” says Alessio Fasano, M.D., director of the University of Maryland (UM) School of Medicine’s Center for Celiac Research and an internationally renowned expert on celiac disease.

FDA Wants to Hear From You About Gluten-free Labeling

Thanks to 1in133.org, a group of folks who built a giant cake for Congress in May of this year, the celiac community and other great organizations, The Food and Drug Administration (FDA) has re-opened the comment period for the proposed rule on the "gluten-free" labeling of foods.  This rule was originally published in 2007, but nothing has been done about it (i.e., no laws have actually been passed).  How important is this?  Very.  As the gluten-free community grows, so does the marketing of so-called "gluten-free" products.  Currently, it is up to each company to set their own standards.   Some are doing a really good job.  They go above and beyond the FDA proposed requirements of 20 ppm of gluten allowed in products after testing.  Others, however, are not. Those who have Celiac Disease or gluten allergies cannot tolerate even a trace of wheat, rye, barley or other products derived from gluten-containing grains (like soy sauce or some anti-caking agents, etc.).  We need proper labeling so that Tender Foodies in the U.S. can be sure that gluten-free labled products are being processed properly.  Gluten-free labeling could also influence the laws around other allergen labeling as well.  As the gluten-free community, and as the Tender Foodie community as a whole has grown, we have also learned.  Lend your experience and voice to this bill.  Do you think it should be more strict?  Have you had experiences with reactions to foods labeled "gluten-free"?  Do you think it is a good rule as is?  Are you super happy that this proposal is resurfacing?  Let them know.  Those with Celiac Disease comprise 1% of the population, or  1 in 133 people.  The gluten intolerance community (those with sensitivities to gluten) is expected to be around 18 million people.  Add those with a true gluten allergy, and you have a large group of folks that need to know if gluten is in their food.  If you are one of them.  Let the FDA know what you want to have happen.

Go to www.regulations.gov between now and October 3, 2011.  The docket number is FDA-2005-N-0404.

On Cookies, Cravings & Mis(taken) Labelings.

The Cravings Made Me Do It

When I started this post, I was about to extol the taste and virtues of these Dark Chocolate, Chocolate Chunk Cookies.  I was about to say how delicious and satisfying they are (and they are); and how much I admire the company who made them for going the extra mile to include multiple allergies. But when I double-checked the ingredients to be sure I was writing about them accurately, I realized why I had such a rough couple of nights after eating them.  Until then, I simply could not pinpoint the reason for my body's allergic reaction.

Before I go on, let me add that If gluten is your only allergy and you love chocolate, these cookies from Pamela's Products are some of the yummier G-free cookies out there.  Go get 'em. 

But they are not yet "dairy-free", even though the label says, "Non-Dairy".  Since I have an allergy to all dairy products, even traces of dairy can cause a reaction.  I'm embarrassed to say that my craving for chocolate coupled with the sound of the word "cookie" just drove me to the shelf without doing my usual ingredient-reading homework.  This mistake plus an FDA approved, but outdated labeling technique, led me down a path that was painful, but interesting.  So, I'm going to use this experience to discuss a few very important things:

• Non-Dairy & Vegan vs. Dairy-free labeling
• Why it is important to call the manufacturer if you have a clear allergic reaction to their product
• How a responsible company/manufacturer should and did respond
• The possibility for allergen-free product companies and factories to expand their mutual markets if they cooperate on a larger scale. 

My Conversation with Pamela's Products

Usually, I am a fastidious ingredient checker -- even if I've used a particular product before.  You never know when the manufacturer of a product might change their recipe.  Sometimes, one producer of just one ingredient could add nuts, dairy or some other allergen to their facility.  But when I picked up this box,  I let the little snack devil in my head make my decisions for me because of this label:

"Wheat-free*Gluten-free*Non-Dairy".

I was sure it wasn't the cookies that made me miserable.  But an empty box (it had been a long time since I ate a cookie) and a couple of long days later, I turned said box over just to be sure.

On the back of the box it states in smaller letters:  "ALLERGEN INFORMATION:  CONTAINS EGGS, SOY, AND MAY CONTAIN TRACES OF MILK."

I picked up the phone immediately and called Pamela's customer service department.  I was upset.  The customer service rep had their marketing director, Stephanie call me back within minutes.  We had an intelligent discussion about several things.

The Real Meaning of "Non-Dairy" & "Vegan"

"Non-dairy" means that there are no dairy ingredients listed in the product.  But the FDA does not define the term "non-dairy", each state does.  This adds complicaton for the consumer.  Also, "Non-Dairy" doesn't take into account that the product, or any ingredient in the product, could be manufactured on the same equipment that also handles an allergen like dairy.  Incidentally, neither does the label, "Vegan".  Traces of milk or any of its derivatives (casein, whey or lactose) left on equipment from another product can be quite significant.  Significant enough to cause a serious reaction.

In researching this article, I found that I am not alone in my mis-interpretation of "non-dairy".  I am allergic to gluten and all forms of dairy - with a slow onset, or IgG reaction (i.e. not an IgE or anaphylaxis) that causes one or more of the following (for me): dull to sharp stabbing pain in my head, dizziness, stuffed nose, swelling (that's attractive), abdominal pain, a digestive standstill, flu-like symptoms, anxiety, numbness and sometimes a racing heart.  These symptoms take several days or more to clear.  I probably won't end up in the hospital because of a mistake, but some people will.    

In a open letter to the FDA encouraging them to change this labeling tactic, The Food Allergy & Anaphylaxis Network (FAAN) describes another twist to the non-dairy labeling:

Many of our members have told us they have purchased “non-dairy” products for their milk-allergic children because they believed these items to be safe.  Individuals often interpret “non-dairy” to mean “no dairy” and therefore do not feel it necessary to read the ingredient statement on the back of the package. In fact, doctors often advise parents of milk-allergic children to avoid “milk”, without informing the patient/parent of technical ingredient names such as casein.  However, FAAN has learned of situations in which “non-dairy” items (such as whipped toppings, imitation cheeses, and soft-serve frozen desserts) have caused milk-allergic reactions in children because it was later discovered that the item contained a milk-derived protein.

Pamela's Products Takes Quick Action

In short, according to labeling laws, Pamela's Products was not wrong for labeling this product, "Non-Dairy".  Plus, they specialize in gluten-free products, not products for multiple allergens.   My phone call was apparently a first for Pamela's, which surprised me and yet didn't surprise me.  I've learned that people are embarrassed.  They are used to just sucking it up and moving on because they feel they "have no choice".  Or perhaps others were just smarter than I was. 

However, Pamela's recognizes that with the increase in the numbers of people with food allergies, as well as the increase in people with multple allergies - they need to evolve more ahead of their customer base.  So they immediately went to work.  Stephanie asked for my email address so she could keep me apprised of her conversations with Pamela herself and their managment team. 

Here is what they have done so far:

• They Stopped the Presses on cookie boxes for their new "Wherever Bars" as they were being printed.  This was at no small expense.  When you see this new product (launched this spring) in stores, you will notice an asterisk (*) next to "Non-Dairy".  This is a temporary change while they consider making more changes to the box design to accommodate better labeling. Rest assured, I'll be looking to see how the change turned out.
  
  
• They are Considering Changing Chocolate Factories.  I put them in touch with Barry-Callebaut Chocolate, a fair trade, high quality company and the only dairy-free bittersweet chocolate factory line in North America.   Callebaut also does not produce nuts or gluten products in their factory, but right now, they only test for dairy.

I appreciate the concern and action from Pamela's Products and have great respect for their immediate response.  In fact, I called them on April 8, 2011 and received these results on April 12, 2011.  They very kindly made it clear that they want to hear from their customers (so give them feedback!), so they can "strive to be the best".

An Expanding Food Allergy Market

Perhaps it is the marketer in me, but I see a huge mult-beneficial opportunity here.  If Callebaut agrees to test also for gluten and nuts, both Pamela's and Callebaut could theoretically expand their markets - possibly significantly.  

Here's some quick data for the United States alone:

• Over 12 million Americans have some kind of diagnosed food allergy - that's 1 in 25 people (FAAN)
• Over 3 million (1 in 133) have celiac disease (celiac.org)
• Millions more have diseases that require a restricted diet (some resources say 3 million, others closer to 11 million)
• Peanut allergies have tripled from 1997-2008 (FAAN)
• There are 4 times more people with celiac than there were 50 years ago (March 2011, University of Maryland study)
• 18 million people suffer from gluten-sensitivity (March 2011, University of Maryland study)
• Many people are developing multiple allergies (data not conclusive)

More data on this expanding market is coming out every day.  My hope is that more Tender Foodies with nut, dairy and gluten allergies (and more?) can experience the products of great companies like Pamela's and Barry-Callebaut.  If my greatest wish could become true, all ingredients would be organic and non-GMO.  Eutopia would be if we could find the cause of food allergies and make them disappear.

While there are some real limiations that need to be acknowledged, something close to Eutopia could be only a few decisions away. 

Enough of us just have to ask for it.  Tell me what you think.

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Recommended Reading:  The Wall Street Journal Article on the Gluten Study

How do I get tested for Celiac? 

Call Me! Wait - Recall me? Product Mistakes in Real Time.

OK, this isn't a really sexy post.  But isn't it nice when people, companies, and especially the government does something to make your life easier?  If a product has been recalled because of an undeclared allergen or nasty, unwanted micro-organisms, wouldn't it be nice have that piece of info delivered to your inbox -- rather than hear about it Ex Post Facto?  If you have a peanut, tree nut, wheat /gluten, dairy, seafood, shellfish, soy, or eggs, you can find out what products have made mistakes in real(ish) time. 

FDA Recall, Market Withdrawal & Safety Alerts

The FDA recently dropped a Press Release into the media about the improved search functionality for their recall database.  They've replaced some laborious text with a nice, easier-to-read table format.  You can sign up to receive email alerts right to your inbox, or add them to your RSS feed. 

To further step into the 21st Century, the FDA also has mobile apps - so you can bring food recalls - and even car and other product recalls right to your mobile phone.

Food Allergy & Anaphylaxis Network (FAAN)

This organization if doing some good work out there.  You can sign up for alerts from FAAN, which includes their organizational news as well.  FAAN's focus is on allergies that cause an immediate life threatening response.