Currently browsing posts about: FDA

Mead-Johnson, the company that prides itself on its “decades-long patterning of infant formulas after breast milk,” now goes one better.  It sells chocolate- and vanilla-flavored formulas for toddlers, fortified with nutrients, omega-3s, and antioxidants.

The company’s philosophy: Your toddler won’t drink milk?  Try chocolate milk!

The unflavored version of this product, Enfagrow, has been around for a while.  In 2005, nutritionists complained about this formula because it so evidently competed with milk as a weaning food.  Mead-Johnson representatives explained that Enfagrow is not meant as an infant formula.  It is meant as a dietary supplement for toddlers aged 12 to 36 months.

Really?  Then how come it is labeled “Toddler Formula”?

And how come it has a Nutrition Facts label, not a Supplement Facts label?

Here’s the list of ingredients for everything present at a level of 2% or more:

• Whole milk
• Nonfat milk
• Sugar
• Cocoa
• Galactooligosaccharides (prebiotic fiber)
• High oleic sunflower oil
• Maltodextrin

I bought this product at Babies-R-Us in Manhattan.  It’s not cheap: $18.99 for 29 ounces.  The can is supposed to make 22 servings (one-quarter cup of powder mixed with 6 ounces water).  At that price, you pay 86 cents for only six ounces of unnecessarily fortified milk plus unnecessary sugar and chocolate.

No wonder Jamie Oliver encountered so much grief about trying to get sweetened, flavored milks out of schools.

But really, aren’t you worried that your baby might be suffering from a chocolate deficit problem?  Don’t you love the idea of year-old infants drinking sugar-sweetened chocolate milk?  And laced with “omega-3s for brain development, 25 nutrients for healthy growth, and prebiotics to support the immune system”?

Next: let’s genetically modify moms to produce chocolate breast milk!

FDA: this package has front-of-package health claims clearly aimed at babies under the age of two.  Uh oh.  Shouldn’t you be sending out one of those package label warning letters to Mead-Johnson on this one?

Addition, May 1: in response to interest in what other products are made by Mead-Johnson, or its parent, the drug company Bristol-Myers Squibb, I’ve linked their names to product pages.

Addition, May 6: Julie Wernau of the Chicago Tribune did a front page (business section) story on this and is following up on it in her blog.

The Washington Post reported yesterday that the FDA is about to launch an initiative to get food companies to reduce the amount of sodium in their foods.

If true, this would be a major big deal.  But by late afternoon, the FDA had issued a press release denying the Washington Post’s report (and see note below):

A story in today’s Washington Post leaves a mistaken impression that the FDA has begun the process of regulating the amount of sodium in foods. The FDA is not currently working on regulations nor has it made a decision to regulate sodium content in foods at this time.

Over the coming weeks, the FDA will more thoroughly review the recommendations of the IOM report and build plans for how the FDA can continue to work with other federal agencies, public health and consumer groups, and the food industry to support the reduction of sodium levels in the food supply.

The FDA is referring to a report also issued yesterday by the Institute of Medicine: Strategies to Reduce Sodium Intake in the United States. According to the IOM Summary, voluntary efforts by the food industry to reduce sodium intake have failed.  The report’s first recommendation is for the government to set standards for the sodium content of packaged foods.  And that sounds like what the Washington Post thought the FDA was about to do.

The idea is to get all companies to start reducing sodium.  USA Today quotes Jane Henney, the previous FDA Commissioner who chaired the IOM committee: “The best way to accomplish this is to provide companies the level playing field they need so they are able to work across the board to reduce salt in the food supply.”

The IOM is doing a public briefing on the report at 10:00 a.m. today, at the National Press Club in Washington DC.  You can listen to it via audio webcast at www.nas.edu.

The Center for Science in the Public Interest (CSPI) first asked the FDA to start regulating salt in processed foods in 1978.  Its press release and report, Shaving Salt, Saving Lives, explain why the FDA’s action would be such good news for public health.

Salt is as controversial as any nutrition issue can get.  I expect plenty of pushback from the Salt Institute and other industry trade groups if there is any hint that FDA might be about to regulate salt content.  Could the FDA’s denial be the result of industry pressure?  It would be interesting to find out.

Some basic facts: Recall that sodium is 40% of table salt (sodium chloride).  Too much raises the risk of high blood pressure and stroke.  Nearly 80% of salt is in processed and pre-prepared foods that are salted before they get to you.

The recommended maximum for adults is 2300 mg or about a teaspoon a day.  If you are at risk for high blood pressure, the maximum is just 1500 mg, or two-thirds of a teaspoon.  Americans consume more than twice that much on average.

Note added April 20: the FDA has produced a Q and A on its salt regulatory policy.

Additions April 21: Here’s the New York Times story on the IOM report.  The LA Times reports on the amounts of sodium in fast food restaurant meals.  Impressive.

On April 16, the CDC published its annual report on foodborne illnesses in a ten-state sample.  CDC writes in passive voice and it’s a struggle to get to the good news:

In comparison with the first 3 years of surveillance (1996–1998), sustained declines in the reported incidence of infections caused by Campylobacter, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC) O157, Shigella, and Yersinia were observed…Compared with the preceding 3 years (2006–2008), significant decreases in the reported incidence of Shigella and STEC O157 infections were observed.

Some consumer groups urge caution in interpreting the drop in toxic E. coli cases, as previous drops have rebounded.

And then there’s the not-so-good news: “The incidence of Vibrio infection continued to increase.”

Vibrio infections reflect the oyster problem I talked about last fall.  The gulf oyster industry is still fighting the FDA over methods to decrease these preventable infections.  Perhaps this bad news will encourage the FDA to get busy and regulate oyster safety.

The Inspector General of the Department of Health and Human Services is worried about FDA’s inspection ability:

• On average, FDA inspects less than a quarter of food facilities each year, and the number of facilities inspected has declined over time.
• Fifty-six percent of food facilities have gone 5 or more years without an FDA inspection.
• The number of facilities that received OAI [Official Action Indicated] classifications has declined over time.  In addition, nearly three-quarters of the facilities that received OAI classifications in FY 2008 had a history of violations. Two percent of facilities that received OAI classifications refused to grant FDA officials access to their records.
• FDA took regulatory action against 46 percent of the facilities with initial OAI classifications; for the remainder, FDA either lowered the classification or took no regulatory action.
• For 36 percent of the facilities with OAI classifications in FY 2007, FDA took no additional steps to ensure that the violations were corrected.

This is also bad news.  Worse, is congressional inaction over food safety.  The House passed its food safety bill–one designed to fix the FDA–last August.  The Senate has yet to deal with its version.  Can food safety wait?  No, it must not.

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.