published Saturday, May 31st, 2014

FDA to update seafood guidance for pregnant women

Food and Drug Administration  Commissioner Dr. Margaret Hamburg answers questions during a newsmaker interview at The Associated Press in Washington on Friday. Hamburg said the agency will soon advise consumers on the appropriate levels of mercury in seafood. In a wide-ranging interview, Hamburg said the agency does not plan to require labels, as requested by consumer groups, but will issue guidance on how much mercury can be present in different kinds of products.
Food and Drug Administration Commissioner Dr. Margaret Hamburg answers questions during a newsmaker interview at The Associated Press in Washington on Friday. Hamburg said the agency will soon advise consumers on the appropriate levels of mercury in seafood. In a wide-ranging interview, Hamburg said the agency does not plan to require labels, as requested by consumer groups, but will issue guidance on how much mercury can be present in different kinds of products.
Photo by Associated Press /Chattanooga Times Free Press.

WASHINGTON — The Food and Drug Administration is updating its advice for pregnant women on the appropriate levels of mercury in seafood but Commissioner Margaret Hamburg said Friday that it won't require mercury labels on seafood packages.

In a wide-ranging interview Friday with The Associated Press, Hamburg said the agency will update guidance on mercury in different varieties of seafood and what that means, a long-awaited move aimed at helping women better understand what to eat when they're pregnant.

"It's an advisory, not an effort to mandate labeling," Hamburg said. "Different seafood products do contain different levels of mercury, and so different seafood products can be rated in terms of levels of mercury."

Eating fish is part of a heart-healthy diet, and many types are good sources of omega-3 fatty acids that are important for brain development.

But fish also can absorb small amounts of mercury, a neurotoxin, from streams and oceans -- and a small number of varieties harbor higher levels.

For most people, accumulating mercury from eating seafood isn't a health risk. But for a decade, the FDA has warned that pregnant women, those who may become pregnant, and young children avoid certain types of high-mercury fish because of concern that too much could harm a developing brain.

Consumer groups have sued the agency, saying the warnings weren't clear enough about what to avoid, and seeking labeling to help so that shoppers wouldn't have to remember which products are OK during pregnancy or for youngsters.

"We can't ask consumers to memorize two different lists of fish," said Caroline Smith DeWaal of the Center for Science in the Public Interest, one of the groups that sued.

DeWaal said the new advisory will be an improvement if it gives consumers better information, especially if that information could be kept at fish counters in grocery stores and retail outlets.

The seafood industry says the government shouldn't look at mercury by itself, but at the benefits of seafood. Jennifer McGuire of the National Fisheries Institute says the original FDA guidelines warning against some types of fish for pregnant women just served to decrease overall seafood intake.

"That would be very concerning if there was a 'good fish, bad fish' list," she said.

The government's 2010 Dietary Guidelines incorporated FDA's warnings to say that pregnant or breastfeeding women should consume 8 to 12 ounces of a variety of seafood per week. But it said they should not eat tilefish, shark, swordfish and king mackerel because of the mercury content and it advised limiting white albacore tuna to six ounces a week.

On other food-related issues, Hamburg said deciding which businesses will have to post calorie labels has been "one of the more complex undertakings of my tenure as FDA commissioner."

The food industry is closely watching FDA to see which establishments are included in final menu labeling rules, which are expected this year. Congress required the labels in 2010 health overhaul, and supermarkets and convenience stores have lobbied aggressively since then to be excluded. But the restaurant industry says that all establishments serving prepared foods should have to post the labels.

She said the increasing amount of caffeine in a whole range of foods "has gotten our attention and concern" and that the agency needs to better understand the role of the stimulant in non-traditional products, especially on children. She said the science is not absolutely clear about its effects.

The agency is investigating the safety of energy drinks and energy shots, prompted by consumer reports of illness and death. FDA is also looking at caffeine in food as manufacturers have added caffeine to candy, nuts and other snack foods in recent years.

On genetically modified foods, Hamburg reiterated her support for voluntary labels, and said a "considerable amount of scientific study" does not suggest the kinds of public health concerns that some consumers have worried about. Advocates for GM labeling have been pushing state laws that require the labels.

As such, she says she does not believe FDA should have to do a mandatory safety review of all engineered foods. FDA now reviews the safety of GM animals, but has a voluntary review for companies that want to sell modified crops for consumption.


Highlights from AP interview with FDA's Hamburg

WASHINGTON — Highlights of interview Friday with Margaret Hamburg, commissioner of the Food and Drug Administration:

PRESCRIPTION DRUG ABUSE

Hamburg downplayed suggestions that the agency might remove a heavily criticized painkiller from the market if a harder-to-abuse version becomes available. She said better abuse-deterrent formulas are needed to prevent abusers from chewing, snorting or injecting pain relievers to get high.

"We feel very strongly that the current technologies available are not adequate to truly turn the tide on the epidemic of abuse, and we need continuing advancement in the field of abuse-deterrent technology," Hamburg said.

The FDA has faced months of criticism from elected officials, law enforcement and anti-addiction groups for approving the powerful painkiller Zohydro last October. The long-acting opioid is the first U.S.-approved pure form of hydrocodone, the most abused prescription drug ingredient in the country. Previously it was only available in lower-dose combination pills like Vicodin.

Agency critics say the FDA should have required Zohydro to be formulated in a way that would make it difficult to abuse. And last month Purdue Pharma, maker of OxyContin, filed for FDA approval of its own crush-resistant hydrocodone tablet. The announcement raised questions about whether the FDA might remove Zohydro from the market if it approves Purdue's hydrocodone drug.

E-CIGARETTES

Hamburg said the agency needs to learn a lot more about what's in electronic cigarettes, how they work and how they are being used.

The FDA in April proposed regulating the popular battery-powered devices that heat a liquid nicotine solution, creating vapor that users inhale. The proposal would ban their sale to minors and require approval for new products and health warning labels.

Hamburg said there is still a lot of controversy over whether e-cigarettes are "a safer tool" that reduces nicotine addictions or whether they just "enable another form of tobacco and nicotine to be used by consumers to keep habits going."

FOOD

Calories on Menus. The food industry is closely watching the FDA to see which establishments are included in the final menu labeling rules, which are expected this year. Congress required the labels in 2010 health overhaul, and supermarkets and convenience stores have lobbied aggressively since then to be excluded. But the restaurant industry says that all establishments serving prepared foods should have to post the labels.

Caffeine. Hamburg said the agency needs to better understand the role of the stimulant in non-traditional products, especially on children. She said the science is not absolutely clear about its effects.

The agency is investigating the safety of energy drinks and energy shots, prompted by consumer reports of illness and death. FDA is also looking at caffeine in food as manufacturers have added caffeine to candy, nuts and other snack foods in recent years.

Genetically Modified Foods. Hamburg reiterated her support for voluntary GM labels, and said a "considerable amount of scientific study" does not suggest the kinds of public health concerns that some consumers have worried about. Advocates for GM labeling have been pushing state laws that require the labels.

As such, she says she does not believe FDA should have to do a mandatory safety review of all engineered foods. FDA now reviews the safety of GM animals, but has a voluntary review for companies that want to sell modified crops for consumption.

Mercury in Fish. Hamburg says the agency soon will issue new advice for pregnant women on the appropriate levels of mercury in seafood, but not labels on seafood packages, as consumer groups have sought.

The advisory is a long-awaited move aimed at helping women better understand what to eat when they're pregnant.

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