by Marion Nestle

Currently browsing posts about: FDA

Nov 7 2013

Trans-fat: FDA proposes to eliminate GRAS status

The FDA has just announced a proposal to withdraw GRAS (Generally Recognized As Safe) status for trans-fat.

My first reaction: Isn’t trans-fat already out of the food supply?  Hasn’t this been one of the food industry’s greatest public health achievements?

Once the FDA started to require trans-fat to be listed on food labels, food companies quickly stopped using partially hydrogenated oils (the source of trans-fat) and found healthier substitutes.  That’s why most food labels list zero grams trans-fat.

But the FDA allows food labels to say zero trans-fat if its amount is below 0.5 gram per serving.

Some manufacturers are still using a little.  This new initiative will encourage them to get rid of those last little bits.

Contrary to the New York Times headline, this is not exactly a ban on trans-fat.  If trans-fat is no longer GRAS, manufacturers can still file a food additive petition to continue using partially hydrogenated oils.

The Federal Register notice asks for input for the next 60 days.

I say congratulations to all:

  • To food companies who worked hard to find ways to substitute healthier fats for trans-fats.
  • To the FDA for finally taking care of the trans-fat 0.5-gram loophole.
  • To Center for Science in the Public Interest for bringing health problems with trans-fat to public attention.
  • To all of the researchers who did the science linking trans-fat to higher LDL-cholesterol levels and to heart disease risk.
  • To the New York City health department for banning trans-fats from use in city restaurants.

Americans will be healthier as a result of all of your efforts.

Resources

At the moment, the FDA has not yet posted its Federal Register notice on the GRAS status of trans-fat. When it does, the notice should be available here.

CSPI’s home page on trans fat

The FDA trans-fat home page

FDA consumer materials

FDA guidance for industry

Research

Sep 27 2013

Whole grain chaos: FDA approves qualified health claim, sort of

In 2012, ConAgra petitioned the FDA to approve use of a health claim on labels and advertising for its whole grain products.  Here’s what ConAgra asked for:

Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.

or

Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.

To say that the FDA was less than impressed with evidence supporting this claim is to understate the matter.  After a comprehensive review of the evidence, here’s what the FDA says ConAgra can use:

Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.

or

Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.

No, this is not a joke.

Congress insists that the FDA must approve health claims, whether supported by science or not.

According to FoodNavigator, ConAgra is happy about this decision.  The first thing anyone will read is “whole grains may reduce the risk of type 2 diabetes.”

As I keep saying, health claims are about marketing, not health.  And qualified health claims are the worst examples.  A plague on all of them!

Aug 7 2013

You think the FDA gets to approve all food additives as safe? Not a chance.

I was invited to write the editorial to accompany a study published today in JAMA Internal Medicine looking at the highly conflicted process used to decide whether food additives are Generally Recognized as Safe (GRAS).

Here’s the study.

Here’s my editorial.

I know this sounds completely crazy, but here’s what the study found:

  • Manufacturers get to decide whether food additives are safe or not.
  • Manufacturers get to decide whether to bother to tell the FDA the additives are in the food supply.

And if they do volunteer to inform the FDA (and many do),

  • Manufacturers get to decide who sits on the panels that review the evidence for safety.

In reading the study, it seemed to me that:

  • As long as not too many people roll over dead after eating foods with new additives, nobody will ever have a clue whether the additive is safe.
  • The regulatory gap has spawned an entire enterprise of GRAS consultants and GRAS consulting firms who are in the business—presumably lucrative—of providing the scientific documentation the FDA needs to determine additive safety.

Some of the consultants need to do a better job.  The FDA raises enough questions that about 15% (my estimate) of the requests would be denied.

The good news: If the FDA sees the safety documentation, it does its job.

But what happens to the rejected additives?  Or the ones that don’t get voluntarily sent to FDA?

Nobody really knows (think: caffeine in alcohol drinks–the FDA had no idea).

We need a better food safety system in this country and conflicts of interests in GRAS additive approvals are a good place to start.

Here’s what USA Today has to say about this (I’m quoted).

 

 

Aug 6 2013

Good news: FDA issues rules for a gluten-free claim on food packages

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

YEAR Action toward completing the rule
2004 Congress passes Food Allergen Labeling and Consumer Protection Act; instructs FDA to issue rule defining “gluten-free.”  FDA establishes Threshold Working Group to review literature on safety cut point.
2005 Threshold Working Group suggests approaches to defining threshold.  FDA asks for comments on the report.  Asks Food Advisory Committee to consider approaches.
2006 FDA posts report and responds to comments.  Announces public hearing.   Gets 2400 comments related to the hearing.
2007 FDA proposes rule to define gluten-free.  Sets 20 ppm cut point.  Begins Health Hazard Assessment.
2011 FDA publishes Health Hazard Assessment.  Reopens comment period.
2012 FDA responds to about 2000 comments.
2013 FDA publishes final rule.

FDA’s documents on the gluten-free rule:

Jul 29 2013

FDA’s latest round of food safety proposals: food imports

The FDA has finally released safety rules for imported foods, two years after Congress passed the food safety law.  OK.   We now have them.  At last.

Here’s what the FDA is up against:

  • 150 different countries ship foods to the U.S.
  • These account for about 15% of the food supply, but 50% of fresh fruits and 20% of fresh vegetables.
  • The agency has the capacity to inspect about 2% of imported foods.

To deal with this disconnect, the FDA proposes to hold importers accountable for the safety of what they ship to us.

The proposed rules allow two ways to do this: Importers can do their own onsite safety audit, or they can verify that their suppliers did so.

Both methods involve verification by certified verifiers that suppliers used “prevention-oriented food safety practices” (HACCP in other words), and achieved the same level of food safety as domestic growers and processors.

Neither requires inspection by FDA, although importers may use inspection.

The proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days.

The previous proposed rules, for produce safety and food production facilities (see below), have been given another 60 days for public comment.  Comments on all proposals will now be due at the same time.  The FDA expect to issue the rules 12 to 18 months after the comments come in and then it will take another 18 months for rules to go into effect.

What does all this mean?

The FDA hardly has the resources to manage U.S. inspections so expecting it to do foreign inspections is unrealistic.  This plan shifts the regulatory burden to producers and shippers (why does this sound like foxes guarding henhouses?).

The FDA also intends to certify third-party auditors.  These invariably involve conflicts of interest, although that system  seems to have worked fairly reasonably well for organic foods.  But we are talking about the safety of imported foods here, and lives are at stake.

This is undoubtedly the best the FDA can do given its limited resources and its problems with Congress.  This Congress is hardly likely to view food safety as a national priority and give the FDA what it needs.

Recall: FDA appropriations go through agricultural appropriations committees, not health appropriations.  And this Congress cannot even pass a decent farm bill.

Congratulations to the FDA for making the best of a bad situation.  And fingers crossed that the proposals survive, get implemented by 2015, and nothing bad happens in the interim.

The document collection:

For a detailed discussion of the pros, cons, and questions, see the account in Food Safety News

May 13 2013

FDA is on the job: health claims

The FDA has sent a warning letter to a supplement manufacturer, Europharma, to cease and desist making health claims for several of its products.  The company, says the FDA, is promoting these products

for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act…because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

For example:
  • The Calm Kids web page links to articles that say “In clinical trials of children with ADD, phosphatidylserine was able to improve attention and reduce symptoms. In fact, 11 of 18 children receiving phosphatidylserine had no further ADD symptoms at all.”
  • The CholestCaps web page links to an article that says “Indian Gooseberry [ingredient in CholestCaps formula]…reduces symptoms of allergies, particularly hay fever [. . .].” and “Indian Gooseberry has proven beneficial in all the disease conditions tested so far [. . .].”
  • The CuraMed web page links to articles that say “Today, we extract curcumin [primary ingredient in CuraMed] from turmeric to use as a natural medicine for cancer, Alzheimer’s disease, arthritis, and many other chronic diseases.”

What’s interesting about this is that the focus is on what the articles say, not what is stated on the website.  This is a new approach for FDA and it will be interesting to see if it works.

According to FoodNavigator.com, Europharma is filing objections, is not admitting wrongdoing, but has removed links to the offending literature from its website.

Progress?

May 9 2013

Wrigley’s withdraws caffeinated gum out of respect for the FDA

The Associated Press says Wrigley’s will temporarily cease and desist trying to market caffeinated gum (see previous post).

The company said Wednesday that it has stopped new sales and marketing of Alert Energy Caffeine Gum “out of respect” for the agency…”After discussions with the FDA, we have a greater appreciation for its concern about the proliferation of caffeine in the nation’s food supply…”

Temporarily?

FDA Deputy Commissioner for Foods and Veterinary Medicine issued this statement:

On May 8, 2013, Wrigley (a subsidiary of Mars) announced its decision to pause production, sales, and marketing of Alert Energy Caffeine Gum. This announcement was made following a series of discussions with the FDA in which the agency expressed concerns about caffeine appearing in a range of new foods and beverages.

The FDA applauds Wrigley’s decision and its recognition that we need to improve understanding and, as needed, strengthen the regulatory framework governing the appropriate levels and uses of caffeine in foods and beverages. The company’s action demonstrates real leadership and commitment to the public health.

We hope others in the food industry will exercise similar restraint….

Congratulations to all concerned.  It’s good to see the FDA on the job.

For an instant explanation of what this is about, see the Wall Street Journal’s elegant illustration:

image

 

May 7 2013

Grocery Manufacturers Association says: Eat less, move more (it’s your fault, not ours)

The Grocery Manufacturers Association (GMA) recently released an interactive  guide to using Facts Up Front, its front-of-package nutrition symbols.

Here’s an excerpt from the GMA’s Infographic:

The GMA’s press release said Facts Up Front

empowers consumers to make informed choices. It arms them with critical nutrition information about their favorite products…Through this website, we are providing consumers with the knowledge and tools they need to build a healthful diet.

The website includes, among other things:

The GMA says:

Facts Up Front labels…highlight nutrition information – calories, saturated fat, sodium and sugar per serving – in a clear, easy-to-understand format. The labels also provide consumers with valuable information about “nutrients to encourage”…The labeling program was developed in response to First Lady Michelle Obama’s call on the food and beverage industry to help consumers construct a healthy diet for themselves and their families.

As I’ve explained in previous posts, I can’t believe that this is what the First Lady had in mind.  I view Facts Up Front as the industry’s end run around the FDA’s long delayed attempt to make front-of-package nutrition information actually useful to consumers.

I’m greatly in favor of eating less, eating better, and moving more as a way to manage weight in today’s food marketing environment.  

But coming from GMA, the message takes on additional meaning: it’s up to you to make healthful food choices.  The companies represented by GMA take no responsibility for the effects of their products on health or of their marketing on your food choices.

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