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FDA finally regulating foods labeled ‘gluten-free’

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August 8, 2011

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Foods that have “gluten-free’’ on their label may actually contain significant amounts of gluten - enough to cause gastrointestinal symptoms in those with celiac disease who have an intolerance to the wheat protein. That’s because the US Food and Drug Administration never established a standard for the label, leaving it up to manufacturers to define what they mean by gluten-free.

Now, though, the agency is moving forward with a new standard that manufacturers will be required to meet before they can slap on the gluten-free label. Federal officials are proposing that cookies, bread, and other wheat products making this claim can contain no more that 20 parts per million of gluten, a level below which gluten cannot be detected by standard lab tests.

It’s the current standard in European Union countries and widely accepted by researchers as a safe level for those with celiac disease, which affects nearly 3 million Americans. Those with the condition suffer damage to the small intestine when their immune system attacks healthy tissue whenever it detects gluten - found in rye and barley as well as wheat.

“There’s no way for those with celiac to know if that brand of crackers they’re buying is really gluten-free,’’ said Linda Antinoro, a registered dietitian at Brigham and Women’s Hospital. “A company can define it as 100 parts per million,’’ a high enough level to trigger cramping, diarrhea, and intestinal inflammation in some celiac sufferers. “We tell patients, if in doubt, leave it out.’’

Some manufacturers of gluten-free products also state on the label that the product contains no more than 20 parts per million of gluten, and Antinoro said that’s a good guide for consumers to use until the FDA issues its final regulations.

The FDA last week invited consumers, celiac experts, and the industry to comment on a rule that it had initially proposed in 2007. (To comment go to and enter docket number FDA-2005-N-0404.) After the comment period closes in two months, the FDA later this year will issue a final rule for the industry to follow that will probably go into effect in 2012.

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,’’ Michael Taylor, FDA deputy commissioner for foods, said in a statement. “We must take into account the need to protect individuals with celiac disease . . . while ensuring that food manufacturers can meet the needs of consumers.’’

Many people without celiac disease embrace the products, believing that avoiding gluten will help them lose weight, improve their mood, or increase their energy. Last year, sales of gluten-free products hit $1.2 billion, more than double the 2005 sales.

“There is no reason to avoid gluten if you don’t have celiac,’’ said Antinoro, “but plenty of my patients with the condition tell me they feel wonderful after switching off gluten.’’ There’s no evidence that gluten-free diets offer any health benefits to those who don’t have celiac.

People most likely feel better, Antinoro added, because they have improved the quality of their diet, cutting out starchy snacks while replacing them with fruits and vegetables. That could also explain why some successfully lose weight - that is, until they discover gluten-free brownies at the health-food store. DEBORAH KOTZ

Corncakes wrote: Antinoro said there is no reason to avoid gluten if you are not celiac. [But] many families with one celiac or gluten intolerant opt to become a gluten-free household, to avoid making the celiacs sick by accidental cross-contamination.

Narfrolyat wrote: Two seconds after you discover the gluten-free brownies, you discover the price sticker on the gluten-free brownies, and you go home and make them yourself for far cheaper.

Kayti wrote: Gluten is also detected in oats.

Deborah Kotz responds: Gluten has been detected in oats, but that’s because of cross-contamination; oats are often packaged in the same processing plant as wheat products. Antinoro told me that she tells her patients to buy only purified oat products.

Good genes, not lifestyle, may be key to getting to 100

As a health reporter, I wish I could ignore some studies - like the one published last week showing that diet, exercise, and other lifestyle choices do not make a bit of difference in getting people to the 100-year mark and beyond.

Study coauthor Dr. Nir Barzilai, who heads the Institute of Aging Research at the Albert Einstein College of Medicine, told me centenarians simply won the genetic lottery, aging slower than the rest of us. “But this population is just 1 out of 10,000,“ he explained. “They’re not us, the poor people who don’t have genes to protect us from smoking, lack of exercise, and a poor diet.’’

The study, published in the Journal of the American Geriatrics Society, did find that men who made it to the century mark were somewhat less likely to have smoked, but women centenarians were just as likely to have smoked as their shorter-lived peers.

When it came to other lifestyle factors - exercise, diet, body weight, alcohol intake - the centenarians didn’t differ from shorter-lived peers. The centenarians were all Eastern European Jews, which may limit the applicability of the findings to others. D.K.

KnobEnd wrote: Outliving your spouse, possibly your children, and spending several decades kicking around without much to do except waiting to be overtaken by the same old-age diseases that eventually get us all doesn’t really sound “lucky’’ to me.

7continents wrote: I always told my Dad he cheated the Grim Reaper out of a good 40 years. He smoked Camel filterless cigarettes, drank, didn’t exercise, ate meat & potatoes (with gravy), eschewed vegetables & made it to 89. OK, not 100 but he sure enjoyed the time he had!

CDC: Hospitals fail to encourage breast-feeding

Despite all the attention paid to the health benefits of breast-feeding, fewer than 4 percent of US maternity hospitals give new mothers the services they need to initiate and stick with the practice, according to a report issued last week by the Centers for Disease Control and Prevention. “Although there has been some improvement . . . we’re still a very long way away from where we want to be,’’ CDC director Dr. Thomas R. Frieden said at a press conference.

Most hospitals still send women home with freebie bags containing bottles and formula samples. And many fail to follow World Health Organization recommendations, which include allowing babies to room with mothers, providing staff for lactation support, and bringing babies to mothers to nurse soon after they’re born.

Massachusetts does better than the national average for its percentage of nursing mothers: In 2007, nearly 78 percent of new moms left the hospital intending to breast-feed, compared with the US average of 75 percent. By six months, half of the state’s mothers were still breast-feeding, compared with 43 percent nationally. D.K.

Cavery123 wrote: My daughter was born 8 months ago and . . . [at] the hospital she was born in they never “pushed’’ formula on me.

Nincyhh wrote: Often parents are not told, or do not believe, that casual use can have longer term impact. Unless formula is medically necessary, exclusive breast milk is the way to go.

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