Currently browsing posts about: FDA

It’s the weekend and I’m cleaning out my e-files.  The Government Accountability Office (GAO), the congressional watchdog agency, has just released a bunch of reports complaining about the way the FDA and USDA do business:

Food Irradiation: FDA Could Improve Its Documentation and Communication of Key Decisions on Food Irradiation Petitions (GAO-10-309R, February 16, 2010, 23 pages).

labels on food products subject to FDA jurisdiction do not have to be reviewed and preapproved by FDA before marketing. Rather, the processor is responsible for properly labeling its products. In fact, FDA officials told us that they do not collect information on how irradiated foods are labeled and marketed. In contrast, USDA reviews and preapproves all labels before use on meat and poultry products and has denied label submissions that do not meet its requirements…FDA does not require the product’s ingredient list to disclose that a particular ingredient has been irradiated, while USDA generally does.

Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (GAO-10-246, February 3, 2010, 69 pages).

FDA only reviews those GRAS determinations that companies submit to the agency’s voluntary notification program…the agency has not systematically reconsidered GRAS substances since the 1980s… FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008…FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA’s knowledge. In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.

Food safety note #1: This arrives in the middle of the latest set of FDA recalls, this time of nearly 100 products made with a flavor enhancer, hydrolyzed vegetable protein, contaminated with Salmonella.

Food safety note #2: the Produce Safety Project at Georgetown University has estimated the cost of foodborne illness:  $152 billion annually, of which $39 billion is due to leafy greens and other vegetables.

Food and Drug Administration: Opportunities Exist to Better Address Management Challenges. (GAO-10-279, February 19, 2010, 54 pages).

Through reviewing reports…GAO determined that FDA’s management challenges include recruiting, retaining, and developing its workforce; modernizing its information systems; coordinating internally and externally; communicating with the public; and keeping up with scientific advances…While FDA has taken steps to align its activities and resources to strategic goals, these efforts in its centers and offices are not clear, making it difficult to connect the agency’s use of resources to the achievement of its goals.

If you feel gossipy (or want to interpret the raw data for yourself), you can read what FDA staff actually told GAO interviewers.

Humane Methods of Slaughter Act: Actions Are Needed to Strengthen Enforcement (GAO-10-203, February 19, 2010, 60 pages). [The actual survey responses are here.  And a shorter version given as testimony is here.]

The guidance does not clearly indicate when certain enforcement actions should be taken for an egregious act–one that is cruel to animals or a condition that is ignored and leads to the harming of animals. A noted humane handling expert has stated that FSIS inspectors need clear directives to improve consistency of HMSA enforcement. According to GAO’s survey, FSIS’s training may be insufficient.

This, one can only assume, is an understatement.

The GAO does important work, no?  Now if only government agencies would listen to it.

You almost have to be sorry for soft drink companies these day.  The latest blow?.  BPA has been found in soft drink cans in Canada (and, presumably, here?).

And the Danes have banned BPA from food packages targeted to children, no doubt, as  the Swiss have shown, bottle-fed infants get the greatest exposure.

In the meantime, everyone keeps saying that current exposures are below safety limits.  Maybe, but the FDA has just released five background documents that it is using as a basis for its current view (“some concern”) and future decision.

Here are some excerpts from today’s FDA press release, “FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry.”

The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act…In an open letter to Industry dated March 3, 2010, Dr. Hamburg underscored the importance of providing nutrition information that consumers could rely on.

…The violations cited in the warning letters include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as “healthy,” and others that have strict, regulatory definitions.  Companies that received warning letters have 15 business days to inform the FDA of the steps they will take to correct their labeling.

Take a look at what the FDA is saying, starting with a handy chart of the affected companies, their products, and the ways their claims violate FDA regulations.  Some of my favorite examples are on this chart (for example, Juicy Juice!).

The FDA also provides:

• Front-of-package labeling information
• Copies of the warning letters
• The letter from Dr. Hamburg to the industry
• Q and A, and
• Link to terms with strict, regulatory definitions

What’s behind all this?  Take a look at Center for Science in the Public Interest’s extraordinary report on violations of FDA regulations on food package labels, Food Labeling Chaos.  No way can the FDA – or anyone else – ignore this report.

Cheers to the FDA for taking this on!

Update March 4:  The New York Times was able to reach some of the affected companies. They all say the same thing (my translation): we are shocked, shocked.  We would never tell a lie.  We will do everything we can to cooperate (make sure the FDA backs down on this).

I have an editorial with David Ludwig in today’s JAMA (Journal of the American Medical Association. NOTE: scroll down to find it).  We titled it, “Front-of-package food labels: public health or propaganda?”

We think it’s time for the FDA to consider getting rid of all of them.  How’s that for an idea?

Here’s what Forbes thinks about it.

And FoodNavigator.com.

Update, February 25: the Los Angeles Times wrote about it.

I went to the reception last week for Diet Coke’s red dress event,:

Diet Coke and the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health have joined forces to raise awareness about women’s risk of heart disease — in support of NHLBI’s The Heart Truth campaign — with a multi-faceted program that will reach consumers across the nation.

To celebrate American Heart Month in February, Diet Coke’s Red Dress Program will take center stage at high-profile events, including sponsorship of The Heart Truth’s, Red Dress Collection fashion show at Fashion Week 2008. Diet Coke will also unveil new packaging and programs featuring The Heart Truth and Red Dress logos and messages on heart health.

The Center for Science in the Public Interest points out that Coca-Cola, whose products are not exactly heart healthy, is a strange partner for the NHLBI.  The agency should reconsider.  It wrote NHLBI to say so.

New York Times reporter Tara Parker-Pope asks: “Should Coke talk about heart health?”

I don’t know how long Diet Coke and NHLBI have been engaged in this partnership but it is surely more than five years.  From NHLBI’s point of view, the partnership publicizes the risk of heart disease to women.  For Coca-Cola, the benefits are obvious.

Are such partnerships a benign win-win?  History suggests otherwise.  In 1984, Kellogg cooked up a partnership with the National Cancer Institute to put health claims for fiber on the boxes of All-Bran cereals (I discuss this incident in Food Politics).  In doing so, Kellogg (and NCI) went around the FDA and undermined that agency’s control over health claims on food packages.  This let to the current mess over health claims, which the FDA is now trying to clean up.

Update March 3: The Public Health Advocacy Institute at Northeastern University has filed a petition to NHLBI to give up the partnership.

The FDA now says it has concerns about BPA and intends to join other federal agencies in a review of the chemical’s safety.   As readers of this blog may recall from previous posts, the FDA has a long-awaited report on BPA sitting in a drawer someplace.  The report was due at the end of November.  Now we can guess the reason for the delay.  The report must have given BPA a pass even though studies seem to be coming in daily suggesting harm.  BPA may not be immediately deadly, but it does not seem good for human health.

The most recent study, this one  from England, looked at dietary intake data in the U.S.   It concluded that BPA is a risk factor for heart disease.  The industry, of course, disagrees.  They think the British study isn’t scientific enough.

Faced with increasing evidence of harm, the FDA is doing the right thing to take this one on.  The problem will be getting rid of BPA.  We can all do our part by avoiding hard plastic bottles, but what about the linings of canned foods?  The canning industry says it doesn’t have a safe substitute.  Until they find one, you will have to add canned foods to the list of foods to avoid.

Cookie dough: Nestlé reports that it has again found E. coli O157:H7 in its cookie dough and will now be heating the flour before using (see, the New York Times account, and the report from FoodProductionDaily.com.

This is odd.  How do they know that the flour is the carrier?   As I discussed in previous posts, the source of the contaminating bacteria has either not been found or not announced.  This action implies that the company must think the flour is at fault.  Let’s hope so.  We certainly don’t want the chocolate bits to be the carrier.

FDA news: The FDA announced yesterday that it has appointed Michael Taylor as Deputy Commissioner for Foods.  This is a new office at FDA which, if Congress ever gets around to passing it, will be responsible for implementing the preventive control provisions of the food safety bill.  Peventive control, I’ve just learned, is the new euphemism for HACCP (Hazard Analysis and Critical Control Point).

As I describe in a previous post, Mr. Taylor’s appointment is not without controversy but his expertise in food safety runs deep.  I think this is a good move for FDA.

Update January 15: And here is what the Washington Post and the New York Times have to say about Taylor’s appointment.  I’m quoted in the Post story.

He is the quintessential revolving door,” said Marion Nestle, a professor of nutrition, food studies and public health at New York University. Taylor’s support for BGH and Monsanto’s other genetically modified products at the FDA was “questionable,” she said. “On the other hand, when he went to USDA, what he did there was absolutely heroic. He’s been very strong on food safety.

I’ve been fretting about the immunity and brain claims on Nestlé’s Juicy Juice for quite some time now, but completely missed the FDA’s December 4 warning letter about them.  Thanks to Hemi Weingarten at Fooducate for keeping track of such things.

If you give these products a moment’s thought, you can quickly figure out that feeding DHA- or antioxidant-fortified juice drinks to kids is unlikely to have much effect on how smart they are or whether they can resist colds or swine flu.  But never underestimate the power of food marketers.   Adding a little DHA or a few antioxidants to juices sells products.  Health claims, as I keep pointing out, are about marketing, not health.

In warning the company to cease and desist, however, The FDA did not take on the health issues.  Instead, it invoked labeling regulations:

The Food and Drug Administration (FDA) has reviewed the labeling for several Nestlé Juicy Juice products…Based on our review, we have concluded that these products are misbranded…. because [their] labeling includes unauthorized nutrient content claims. Except for statements that describe the percentage of a vitamin or mineral in relation to a Reference Daily Intake (RDI), a nutrient content claim cannot be made for a food intended for use by infants and children less than 2 years of age….On October 30, 2009. we also reviewed your website….The labeling found on your website makes an additional unauthorized nutrient content claim, which further misbrands the product. The website claims that Juicy Juice Brain Development Fruit Juice Beverage is “naturally lower in sugar”…[but] no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations.

Additionally, we have reviewed the labeling of your Nestle Juicy Juice All Natural 100% Juice Orange Tangerine and Nestle Juicy Juice All Natural 100% Juice Grape products. These products are misbranded…because their labels are misleading. The label of the Orange Tangerine product is designed to imply that the product is 100% orange/tangerine juice, and the label of the Grape product is designed to imply that product is 100% grape juice…neither orange/tangerine juice nor grape juice is the predominant juice in the products….

Nestlé (alas, no relation) is the largest food company in the world with $102 billion in sales last year.  It should know better.

Just for the record, the misbranded products are still displayed on the Juicy Juice website.

The FDA also warned Nestlé that its Boost Kids Essentials products are misbranded. Why?  Because their labeling does not follow the rules for medical foods, those aimed at alleviating specific conditions – in this case “failure to thrive.”   Oops.  The Boost Kids Essentials website is now under revision.