Currently browsing posts about: FDA

Food Safety: FDA Has Begun to Take Action to Address Weaknesses in Food Safety Research, but Gaps Remain. GAO-10-182R, April 23, 2010 (23 pages).

Imported food makes up a substantial and growing portion of the U.S. food supply, with 60 percent of fresh fruits and vegetables and 80 percent of seafood coming from across our borders….In January 2007 GAO designated federal oversight of food safety as a high-risk area needing urgent attention and transformation because of the federal government’s fragmented oversight of food safety. The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply–virtually all domestic and imported foods except for meat, poultry, and processed egg products–valued at a total of $466 billion annually, as of June 2008.

Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities.  GAO-10-699T, May 6, 2010 (20 pages).

In 2008, FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA…. FDA estimated that it would conduct 200 inspections in 2009 and 600 in 2010. GAO previously identified several gaps in enforcement that could allow food products that violate safety laws to enter U.S. commerce. For example, FDA has limited authority to assess penalties on importers who introduce such food products, and the lack of a unique identifier for firms exporting food products may allow contaminated food to evade FDA’s review.

As it has been saying for years, GAO wants FDA to ask Congress to give it statutory authority to:

• Recall products identified as unsafe
• Require companies to demonstrate that food ingredients are safe before using them
• Require preventive controls (e.g. HACCP) by firms producing foods that have been associated with repeated instances of serious health problems or death.

Note that the FDA does not have this authority now and must seek it from Congress.  The food safety bill now before Congress does some of this, which is one reason why it should be passed.  Note: the House passed the bill last August.  Eleven months later, the Senate is still sitting on it.  Not helpful.

Addition: Consumers Union has produced a video—starring Eric Schlosser—on why the Senate must pass the food safety bill, and right away.

Update, July 8: President Obama states support of the Senate’s food safety bill.

I keep complaining about the health claims on Enfagrow toddler formula, a sugary product aimed at children from ages one to three:

These claims, for the uninitiated, are a special kind called structure-function.  Congress authorized such claims when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Structure-function claims do not say that the product can prevent or treat disease. They merely suggest that the product can help in some unspecified way with some structure or function of the body.

When Congress passed DSHEA, it meant the claims to apply to dietary supplements, not foods. Enfagrow is marketed as a food, not a supplement.  It displays a Nutrition Facts label, not a Supplement Facts label.

Over the years, the FDA has issued cease-and-desist warnings about foods that bear structure-function claims.  In recent years, it has simply stated that manufacturers are responsible for ensuring that the claims are “truthful and not misleading.”

One reason for the shift is what the Courts have ruled.  The Courts say that structure-function claims are protected by First Amendment guarantees of free speech.  The most recent case is Alliance for Natural Health USA v. Sebelius. As described in Food Chemical News (June 7), a D.C. District Court judge ruled that the FDA cannot deny health claims that link selenium supplements to reduced risk of several diseases, or require those claims to be qualified, just because the claims lack adequate scientific substantiation.

In other words, supplement makers can say anything they want to about the benefits of their products—on the grounds of free commercial speech—whether or not science backs up the claim.

Recently, the FDA issued a warning letter to Nestlé, the maker of a Juicy Juice product aimed at toddlers, which displays a claim that its content of added omega-3 DHA improves brain development.  The FDA did not take on the claim, even though research seems unlikely to find that such drinks have any special benefits for brain development.  Instead, the FDA focused on a technicality:

The product makes claims such as “no sugar added,” which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.

I’m guessing—this is speculation—that the FDA is reluctant to take on Enfagrow’s brain or immunity claims because Mead-Johnson has deep pockets and might well be willing to fight this one in court as a First Amendment case.

I am not a lawyer but I thought that intent mattered in legal cases.  Surely, the intent of the founding fathers in creating the First Amendment was to protect the right of individual citizens to speak freely about their political and religious beliefs.  Surely, their intent had nothing to do with protecting the rights of supplement, food, and drug corporations to claim benefits for unproven remedies, or to promote sales of sugary foods to babies.

I think it is time to give these First Amendment issues some serious thought.  How about:

• FDA: Fire those lawyers and hire some who will protect the FDA’s ability to use science in its decisions.
• FTC: Take a look a the immunity claim on the Enfagrow Vanilla toddler formula, now that the Chocolate is off the market.
• Legal scholars: Surely there are ways to protect real First Amendment rights while restricting unsubstantiated health claims?

Other ideas are most welcome.  Your thoughts?

Mead Johnson announced yesterday that it was withdrawing its Enfagrow Chocolate Toddler Formula–just the Chocolate version–from the market:

Like all our Enfagrow Premium products, the recently introduced chocolate-flavored version has a superior nutritional profile to many other beverages typically consumed by toddlers — including apple juice, grape juice, and similarly flavored dairy drinks. Unfortunately, there has been some misunderstanding and mischaracterization regarding the intended consumer for this product and the proper role it can play in a child’s balanced diet. The resulting debate has distracted attention from the overall benefits of the brand, so we have decided to discontinue production of Enfagrow Premium chocolate toddler drink and phase it out over the coming weeks.

I can’t resist quoting the Chicago Tribune’s explanation of the origin of the debate caused by “misunderstanding and mischaracterization:”

Introduced in February, the chocolate-flavored formula was widely criticized in the blogosphere after Marion Nestle, professor of nutrition, food studies and public health at New York University, wrote that the drink would lead children to crave sugary beverages on her influential blog, www.foodpolitics.com.

Influential?  Maybe, but it seems that my comments on this formula did not go nearly far enough.  Mead-Johnson may be withdrawing the Chocolate version, but it is keeping the Vanilla (as explained by Susan James on ABCNews.com, which also quotes me).

What’s the difference?  The Vanilla has exactly one gram less sugar than the Chocolate, 18 grams per 6-ounce serving, rather than 19 grams.  In contrast, the milk in my refrigerator has 9 grams of sugar (natural, not added) in 6 ounces.

Clearly, Mead-Johnson doesn’t get that it’s the sugars, stupid.

Why do I think this is a PR stunt?  Three reasons:

• The Vanilla doubles the sugars in regular milk.
• The Vanilla has the same health claims as the Chocolate: growth, brain development, and immunity.
• Mead-Johnson’s stock went up after the announcement.

One more time: Where are the FDA and FTC on this product?  This Immunity claim is no different from the one on Kellogg’s Krispies cereals that the FTC went after a couple of days ago.

Tomorrow: Some speculation on why the FDA is reluctant to take on things like this.

Addition, June 11: Here is Melanie Warner’s take on this on her BNet Food Industry blog site (she quotes my post).

The FTC has imposed new advertising restrictions on Kellogg because of the Immunity claim on Rice Krispies.  The company is not to make claims about “any health benefit of any food  unless the claims are backed by scientific evidence and not misleading.”

Under a previous order dealing with Frosted Mini-Wheats, Kellogg was not supposed to make claims about benefits to cognition on any of its cereals or snack foods unless the company could prove that the claims were backed by real science. This new decision extends that ruling to include any claim at all.

OK, but I’m confused about several aspects of this decision:

• How come the FTC is doing this and not the FDA?  At some point years ago, regulatory responsibility was split between FDA and FTC.  Since then, the FDA regulates claims on food package labels, whereas the FTC regulates advertising claims.  I realize that food labels are a form of advertising, but it’s unusual and surprising for the FTC to get involved in FDA-regulated matters.
• As FoodNavigator also wonders, why didn’t the FTC fine the company and, instead, write a harsh letter? [see update below]
• Why is the FTC doing this?  Kellogg agreed months ago to withdraw its Immunity claim ( see my November 5 post about the withdrawal).  The Immunity boxes gradually disappeared from supermarket shelves and I haven’t seen one for a long time.

So what’s going on here?  Is the FTC getting serious about regulation (and about time, too)?  Or is FDA sitting back and letting the FTC do its enforcement work?

Could this be why the FDA hasn’t sent a warning letter to Mead-Johnson, the maker of the chocolate toddler formula with three health claims aimed at kids ages 1 to 3.  I posted about this product on April 26, but haven’t heard whether the FDA is doing anything about it.  Can the FTC be on this case but waiting for investigations to be completed before taking action?

Kellogg, it seems, is under fire on all fronts.  CSPI’s Margo Wootan sent me the recent decision by the Children’s Advertising Review Unit of the Better Business Bureau that Kellogg must stop advertising Pop-Tarts to kids:

CARU was concerned that the product packaging, which features berries and states “Made with Real Fruit” for several of Kellogg’s Pop-Tarts®  products that have fruit in their names, impliedly represents to children that the products contain substantial amounts of fruit.

In fact, according to CARU, Pop-Tarts contain less than 6% fruit and less than 2% of the fruit shown in the advertising. Kellogg claimed that its marketing was not aimed at kids, but lost that one.

It’s great that regulatory agencies like FTC and FDA (and voluntary agencies like CARU) are regulating but it’s hard to keep track of who is doing what.   Nothing to do but wait and see what happens next.  Stay tuned.

Update, June 8: CSPI’s Margo Wootan writes that FTC can’t impose fines because it does not have the authority to issue civil penalties.  Ted Mermin of Public Good Law concurs.  He says:

Companies fight hard to make FTC (and similar) orders as narrow as possible, in large part to avoid precisely the situation in which they are held responsible for violating an existing injunction/order.  Since (in the Commission’s view, at least) Kellogg hadn’t violated an existing order, the FTC did not have the authority to fine them without first going to the US Department of Justice to get DOJ to take the case (a matter of a 45 day delay, if DOJ takes it at all).  The burden of that delay (and of needing to get authority from DOJ in the first place) is precisely what is driving the congressional charge for enhanced FTC authority as part of the financial reform legislation.

If the House version of financial reform legislation had been in effect, the FTC would have had the authority to seek civil penalties (i.e., fines) and the outcome here might have been different.  As it was, the fact that Kellogg had stopped the practice…kept the Commission (at least the three commissioners in the “majority”) from focusing on any remedy other than injunctive relief–that is, a broadening of the existing order from the Mini-Wheats case, with the threat of that $16,000 per violation (and an expanded area of prohibited activity) running into the future.

Update, June 11: In an editorial titled “Snake oil for breakfast,” the New York Times explains why health claims matter so much.  If you can’t believe health claims, what part of the food label can you believe?:

Businesses have been making dubious claims about their products at least since the 17th century, when the British clergyman Anthony Daffy sold Daffy’s Elixir as a cure for scurvy as well as agues, gout, rheumatism, rickets, worms and other ailments. Hucksterism — no matter how implausible the claim — lives on…[for example] POM Wonderful claimed its pomegranate juice helps treat, prevent or cure hypertension, diabetes and cancer.  This might be par for the course for an era of swift-boating political ads and a torrent of television commercials plumping for myriad wonder drugs (sudden death may result). It leaves the consumer in a quandary: what part of the label can be believed?

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.