Yesterday’s New York Times displayed a full-page advertisement for Gerber baby food (owned by Nestlé, no relation):

Gerber is taking more than baby steps to reduce the risk of certain allergies

.…The FDA concludes that current scientific evidence is appropriate for consideration of a claim regarding the relationship between the consumption of 100% whey-protein partially hydrolyzed infant formula and reduced risk of atopic dermatitis.

….We’re proud to say that Gerber Good Start is the first and only formula brand made from 100% whey-protein partially hydrolyzed.  In contrast, most other routine milk-based formulas are made with intact cow’s milk protein.

Translation: Some infants are allergic to the proteins (whey) in cow’s milk.  Treating the proteins so they are split apart into smaller fragments (partial hydrolysis) apparently destroys some of their ability to elicit allergic immune reactions in the skin.

But here’s where the ad gets totally weird:

The FDA has concluded that the relationship between 100% whey-protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.  Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.

Huh?

Blame Congress for this one.  It insists that the FDA allow “qualified” health claims” for which scientific evidence is uncertain.

If you want to know why the FDA can’t seem to get anything done, take a look at what it’s staff had to do to respond to the Gerber petition.  Graduate students take note: this is an exhaustive review of scientific studies on the relationship between hydrolyzed whey protein and infant skin allergies.

Here is the FDA’s conclusion, written in FDA-speak, about Gerber’s petition for a health claim:

In light of the above considerations, FDA intends to consider the exercise of its enforcement discretion for the following qualified health claims (my emphasis):

1. “Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.”

2. “Little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life.”

3. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is very little scientific evidence for the relationship.”

4. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.”

Why would Gerber’s place a hugely expensive full-page ad in national newspapers to celebrate a decision like this?  Because it knows that any health claim, no matter how poorly substantiated by science, gives it a competitive advantage.

This is reason enough to promote breastfeeding.

The L.A. Times has one of the better stories I’ve seen lately about genetically modified (GM) foods.  I don’t usually write much about this topic because there is so little new to say about it.

I’ve been writing about GM foods for 20 years now and I’d call it a stalemate.  The industry says:

• GM foods are absolutely necessary to feed the world.
• Farmers love them.
• They are harmless.

Farmers do like using them because they do not have to do as many pesticide applications or worry as much about weeds.

But the first and third points are highly debatable, as the article discusses.

I worry most about two aspects of GM foods:

• They encourage corporate control of the food supply and monoculture (never good ideas)
• They do not give consumers choices because they aren’t labeled.

The LA Times illustrates both points in one terrific graphic:

The states are starting to act, but this is really the FDA’s issue.  It’s time to get the FDA to reverse its 1994 decision not to label GM foods.

In April, the FDA released proposed rules for listing calories on menu labels (see previous post).  One surprising omission was an exemption for alcoholic beverages.  The surprise was that FDA had included alcoholic beverages in earlier versions.

The FDA’s reason for omitting alcohol is that these drinks are regulated by the Treasury Department, which proposed rules for calories on the labels of such drinks.  Yes it did, but that was at least four years ago and Treasury has done nothing since.  And Treasury has never said a word about menu boards.

Jurisdiction cannot be the real reason.  FDA does not regulate meat and poultry (USDA does) but its proposed regulations cover those foods.

If you think the FDA should require restaurants to display calories for alcoholic beverages, now is the time to say so.

I think consumers’ right to know is a sufficient reason for demanding calorie labeling on alcoholic beverages, but if you want more, the Marin Institute  lists useful talking points.

• Alcoholic beverages contain calories and few nutrients.
• It is difficult for drinkers to calculate the number of calories contained in a specific alcoholic beverage on their own.
• Congress did not explicitly exclude alcoholic beverages from food labeling requirements.
• The FDA has jurisdiction over the regulation of alcoholic beverages for health purposes.
• The TTB [Treasury Department agency] continually fails to act regarding the labeling of alcoholic beverages.
• Exempting small alcohol producers can remove burden of obtaining nutritional information.

If you are convinced by these arguments, or have others of your own, be sure to share them with FDA.  Do it right away.  The deadline is July 5.

On May 24, an administrative law judge will deal with the matter of the Federal Trade Commission’s (FTC) complaints that health claims made for POM Wonderful pomegranate juice are unsubstantiated by science.

To review:  last September, the FTC complained that the company was advertising its juice with unsubstantiated claims like these:

• Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;
• Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat prostate cancer, including by prolonging prostate-specific antigen doubling time;
• Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The FTC argues that these claims are false because POM Wonderful’s studies do not prove what the company claims.  The FTC particularly takes exceptions to the company’s advertisements:

• Washington Post Advertisement
• Banner Advertisement
• Fitness magazine Advertisement

If you want to follow the legalities, the FTC provides a handy summary.

According to FoodNavigator.com, this company must be supporting armies of lawyers:

POM is currently embroiled in a complex web of litigation, having itself launched legal action against the FTC alleging it had exceeded its statutory authority by establishing a two-clinical trial standard to back claims.

It has also filed actions against Coca-Cola Minute Maid, PepsiCo Tropicana and Ocean Spray alleging misleading claims about the contents of their pomegranate-containing juice products.

Separately, POM is itself accused of misleading consumers in a class action lodged in a Florida state court.

Leaving this particular company’s legal strategies aside, at issue is whether food health claims need to be backed up by science.   POM says it has the science.   The FTC says it doesn’t.   I will have more to say about that issue in subsequent posts.

In the meantime, it will be interesting to see what happens at the hearing.  Stay tuned.

Michael Taylor, FDA’s associate commissioner for foods, gave a major speech yesterday at the George Washington University School of Public Health.

In it, he talked about the origin and effectiveness of HACCP (Hazard Analysis and Critical Control Point) controls for preventing food safety problems.  HACCP, he explained, works just like other aspects of public health practice.  It requires:

• understanding the specific food safety hazards that could affect a particular food production operation,

• devising and implementing scientifically validated controls to minimize the hazards,

• monitoring the implementation of preventive controls to verify effectiveness, and

• making corrections and adjustments as needed, based on experience.

He then went on to say how FDA plans to put the Food Safety Modernization Act into action:

We are well on our way to developing a proposed produce safety rule that addresses areas such as employee hygiene, water quality, soil amendments, and animals in the growing area, as FSMA mandates.

In food facilities, such as processing and packaging plants, we will be proposing rules that are grounded in the widely embraced principles of preventive process control for food safety, similar to HACCP.

The law requires each facility to… (1) evaluate the hazards that could affect food safety, (2) specify what preventive steps, or controls, to put in place to minimize or prevent these hazards, (3) specify how the facility will monitor these controls to ensure they are working, (4) maintain routine records of monitoring, and (5) specify what actions the facility will take to correct problems that arise.

For example, in a facility that produces peanut butter, factors such as  ingredient safety, sanitation, and cross contamination would have to be considered. After the outbreak of Salmonella typhimurium in peanut butter in 2008 and 2009, which caused 714 cases of illness, the company had to reevaluate the hazards in its facilities so this wouldn’t happen again.

Such review and correction – and a sharp focus on specific hazards – will become the norm under a system of preventive controls.

Taylor outlined FDA’s vision for preventive controls from farm to table.  Now, if Congress will just give it the resources to do all this, we might actually have a food safety system that functions.

A reader, Jeff Harpell, comments on my scheduled talk in Barcelona:

I lived in Barcelona last year and the year before….While they are becoming more influenced by American fast food, having both parents work, and buying more from one stop food markets, the lifestyle, social support systems, i.e., healthcare and eating habits still are very different from the USA

….I suspect that the Catalonians are concerned about their citizens’ heading down a path of bad eating habits and how to prevent them. Any thoughts to share?

Three first impressions:

1.  The tourist bureau on La Rambla gives out a free city map courtesy of McDonald’s.  The map helpfully identifies the location of all of the McDonald’s outlets in Barcelona, and its such a relief to know that you don’t have to go far to find one.  I counted at least 10.

2.  The Carrefour supermarket has a meat section unlike any supermarket meat section in the United States. Those unwrapped hams are not cheap (yes, that’s 79 Euros, nearly $140, but it’s a big ham).  Leaving the ham attached to the hoof is an interesting touch.  I can only imagine what the New York City health inspectors might say about them.

3.  The Boqueria open-air food market has the most beautiful cut fruit for sale—something like this would make getting those daily fruit servings a real treat.

More to come!

FDA’s program is generally limited to enforcing the Hazard Analysis and Critical Control Point—the internationally recognized food safety management system—by conducting inspections of foreign seafood processors and importers each year.

These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms.

The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood.

• Aquaculture assessments have been limited by FDA’s lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country’s fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU.
• FDA’s sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce.
• FDA’s sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent.
• In fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues.
• FDA’s reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency’s use of resources.
• FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years.

And Congress wants to cut FDA’s resources.  I have no doubt that the FDA could be more efficient but the scope of what it is expected to do with limited resources is beyond absurd.

From where I sit, the entire food safety system needs an overhaul and the problems with food imports are a good reason for doing that.

Sunday’s New York Times has not one but two articles about “functional foods,” those with something added over and above what’s in the food in the first place.

A front-page story, “Dessert, laid-back and legal,” describes brownies.  No, not brownies laced with marijuana.  This time they contain the sleep-inducing drug melatonin.

The brownies, according to the Times, contain just as much melatonin as are found in drug pills but are cheaper and can be purchased with food stamps (another reason for taking a look at the whole question of SNAP benefits?).

Since melatonin is a drug and not an approved food additive, the makers of these products are trying to get around the annoying FDA restrictions by marketing the brownies as “dietary supplements.”  Supplements, by order of Congress when it passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, do not have to meet FDA’s rigorous scientific criteria for safety or efficacy.

DSHEA applied to supplements, not foods, but the FDA has chosen to regulate foods containing such additives by the weaker rules applying to supplements and to deal with them as a regulatory gray area.   Is melatonin a drug, a supplement, or in brownie from a food?  The FDA is going to have to decide this, and fast.

A much longer story in the business section, “Foods with benefits, or so they say” (in which I am quoted) focuses on the entire point of functional foods: the ability to put something in a product that allows you to market it using health and wellness claims.  Health claims sell food products.  People like buying products with a “health aura,” no matter how poorly the health claim is supported by science.  Science is irrelevant here.  Marketing is what’s relevant.

As I discuss in my book, Food Politics, until the early 1990s, the FDA did not allow health claims on food products.  Claiming a specific health benefit for a food, said the FDA, meant that the food was being marketed as a drug.  If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

When Congress passed the Nutrition Labeling and Education Act in 1990, it struck a deal with the food industry.  The industry was objecting that because Nutrition Facts labels required them to say what was bad about their products, they ought to be allowed to say what was good about them.  Congress agreed, and forced the FDA to review the science linking certain food ingredients to health benefits as a basis for permitting health claims.

The FDA approved some claims but rejected others.  The rejected companies took the FDA to court, and the courts mostly ruled in favor of the companies on the grounds of the First Amendment.  The FDA stopped trying to control unsupported health claims and only recently has taken then on again.

But as sales soar, federal regulators worry that some packaged foods that scream healthy on their labels are in fact no healthier than many ordinary brands. Federal Trade Commission officials have been cracking down on products that, in their view, make dubious or exaggerated claims. Overwhelmed regulators concede that they are struggling to police this booming market, despite recent settlements with makers of brands like Kellogg’s Rice Krispies and Dannon’s Activia, which the authorities say oversold their health benefits.

To the distress of international food marketers, the U.S. currently has much looser regulations about health claims than are available in Europe.  The European Food Safety Authority has been reviewing thousands of petitions for health claims on food products and turning most of them down as scientifically unsubstantiated.  That doesn’t stop American food makers from loading on the claims.

From the ivory tower in which I sit, the remedy is easy: don’t allow health claims on processed foods at all.  The claims are all inherently misleading, as would be obvious if you gave it a minute’s thought.

But if they aren’t worth much to you, they are worth plenty to the marketers of processed foods.  And that’s what this is really about.