European food manufacturers continue to file thousands of petitions for approval of health claims for their products.  The European Food Safety Authority (EFSA) takes a dim view of most of them, arguing that the claims are poorly substantiated by scientific evidence, if at all.

Now EFSA is attempting to clarify what manufacturers have to do to gain approval for their claims.  I say “attempting” because EFSA’s statements often are models of bureaucrat-speak.

EFSA, for example, says it is willing to consider evidence for claims based on studies performed in people with a particular disease:

For studies in groups (e.g. subjects with a disease) other than the target group (e.g. general population) for a claim EFSA considers whether scientific conclusions can be drawn for the substantiation of the claim on a case by case basis…For example, for claims on reducing gastro-intestinal discomfort (in the general population) evidence in patients with irritable bowel syndrome may be accepted.

OK.  I get that.  Then it offers further clarification:

For claims on maintenance of normal joints (in the general population, evidence in osteoarthritis patients is not accepted as osteoarthritis patients are not considered to be representative of the general population with regard to the status of the joint tissues.  In its evaluation, EFSA considers that where a health claim relates to a function that may be associated with a disease, subjects with the disease are not the target for the claim.

EFSA explains its overall philosophy for deciding which claims to approve.  It does not use a pre-established formula for the type or number of studies.  Instead, it weighs:

All the evidence from the pertinent studies (i.e, studies from which scientific conclusions can be drawn for substantiation of the claim)…with respect to its overall strength, consistency and biological plausibility, taking into account the quality of individual studies and with particular regard to the population group for which the claim is intended and the conditions of use proposed for the claimed effect.

As with all scientific evaluations, EFSA’s judgments are subjective.  It considers animal studies, but grants more weight to studies in humans.  These, it says, are “central for the substantiation of the claim.”

Food manufacturers also view the evidence subjectively, but tend to be less scientifically rigorous in their interpretation of benefit, especially when their own products are involved.   Hence: conflict.

At the moment, EFSA is holding a hard line on health claims.  FDA: take notice!

The supplement industry has its hands full these days trying to keep up with negative publicity about taking vitamins.    Its latest damage-control efforts are aimed at some Norwegian studies published in this week’s Journal of the American Medical Association (JAMA).  Norway does not fortify foods with folic acid and investigators evidently wanted to know if the vitamin was safe.  They gave various combinations of vitamin supplements to heart disease patients.  Oops.   Patients taking folic acid and vitamin B12 had higher death rates than those taking no supplements or vitamin B6.  The excess deaths were generally from cancer, mostly of the lung.

Implications?  Like all such studies, this one requires interpretation.  The supplement industry has one interpretation.  Others are likely to follow.

But maybe it’s time to think more carefully about adding folic acid to the food supply?  We add folic acid to flour in the U.S. in an effort to reduce prenatal risks for neural tube disease (NTD).  Rates of NTD have decreased with folic acid fortification, but they might have done so anyway.  Maybe taking single vitamins is not such a good idea?  Maybe we need a whole lot more research on mechanisms of action?  Do vitamins promote the growth of cancer cells, for example?  Are people with heart disease especially susceptible to excessive vitamin intake?  And maybe we need stronger regulation of dietary supplements?  What a concept!

For the supplement industry, these kinds of studies mean bad news.  Nutrition Business Journal worries about how such research will affect sales.  Watch the industry spin on this one.

First, the “Nutrifluff,” my term for research with results that are intriguing but of unknown clinical significance.  I thank everyone who sent me links to the New York Times account of the new study linking chocolate milk to reduced inflammation.  It quotes the lead author:  “Since atherosclerosis is a low-grade inflammatory disease of the arteries, regular cocoa intake seems to prevent or reduce [it].”   But the giveaway is the next magic words that cover all bases: “more studies needed.”

The study suggests – but in no way proves – that drinking chocolate milk reduces the risk of coronary artery disease.  Inflammation is an intermediate marker of suggestive but unconfirmed clinical implications.  More research is needed, indeed.

Next, policy.  Recall the fuss over chocolate milk (see previous post on the topic)?   Marlene Schwartz of the Rudd Center at Yale has posted an explanation of her views on the matter.

The “chocolate milk controversy” story this week is not about nutrition; it’s about marketing…They explain that “more than half of all flavored milk is sold in schools,” and “the importance of flavored milk goes beyond the school market because it is a key growth area for milk processors.”

They are trying to sell their product. There is nothing wrong with that as long as their marketing efforts are not misleading. Chocolate milk is not the nutritional equivalent of regular milk. It is significantly higher in calories, sugar (often high fructose corn syrup), sodium, and usually contains artificial colors and flavors.

In the promotional video on YouTube, expert dieticians acknowledged that chocolate milk has about 60 more calories per serving than regular milk, but then quickly added that “in the grand scheme of things, that’s nothing compared to the amount of nutrients they are going to be getting.”

That sounded really familiar.

“In the grand scheme of things, these calories don’t count” is exactly what we heard from David Mackay, the CEO of Kellogg in his defense of marketing his company’s high-sugar cereals: “Twelve grams of sugar is 50 calories. A presweetened cereal as part of a regular diet for kids is not a bad thing.”

50 calories here, 60 calories there, and pretty soon we are talking about real weight gain.

Our research has found that children will eat low-sugar cereals and drink white milk when these are the foods that are served. We also found that most children will also eat a piece of fruit if you prompt them to take it. School cafeterias are the perfect place to reinforce the nutrition lessons that begin at home and promote nutrient-dense foods.

If chocolate milk were the only treat children were exposed to in schools, it would not be nearly as much of a problem.  But it is not.  In many schools, kids are offered sweet treats all day long (birthday celebrations, rewards from teachers, etc) or exposed to those readily available from vending machines.  So sweet foods have become the norm.  Norms are hard to change, but let’s at least not make them worse.

The New York Times reports that the company selling contaminated ground beef responsible for killing two people and making 500 others sick, “stopped testing its ingredients years ago under pressure from beef suppliers.”

Recall that since 1994, the USDA bans E. coli 0157:H7 in ground meat.  It encourages, but does not require, meat companies to test for the pathogen. Why don’t they test?  Because they don’t have to.

If they did test, they might find toxic E. coli and have to cook or destroy the meat.  As the Times reported in depth last month, Testing puts meat companies in “a regulatory situation.”  As one food safety officer put it, slaughterhouses do not want his packing company to test for pathogens: “one, I have to tell the government, and two, the government will trace it back to them. So we don’t do that.”

Instead of requiring safety testing, the USDA uses a “restrained approach.”  As Dr. Kenneth Petersen, an assistant administrator with the USDA’s Food Safety and Inspection Service, told the Times, USDA has the power to require testing but doesn’t use it because it has to take the companies’ needs into consideration: “I have to look at the entire industry, not just what is best for public health.”

The moral?  Meat companies will only produce meat safely if forced to.  As we saw yesterday, oyster companies will only produce safe oysters if they have to.  That’s why we need a food safety system in which all foods have to be produced safely.  What will it take to get Congress to act?

On November 13, the FDA announced indefinite postponement of rules requiring raw oysters from the Gulf of Mexico to undergo postharvest processing to destroy their content of Vibrio vulnificus, a particularly nasty “flesh-eating” bacterium.  According to accounts in the New York Times and in industry newsletters,  the FDA caved under pressure from the oyster industry and members of Congress representing oyster-harvesting regions in the Gulf.

The FDA has been trying for years to get the oyster industry to clean up its act and use post-harvest technologies to sterilize oysters in order to prevent the 15 or so deaths they cause every year.  The technologies include quick freezing, frozen storage, high hydrostatic pressure, mild heat, and low dose gamma irradiation.  When used, the methods reduce bacteria to undectable levels and deaths from Vibrio vulnificus infections to zero.  As the FDA puts it, “seldom is the evidence on a food safety problem and solution so unambiguous.”

The FDA took action on October 16.  It wrote a letter to the industry announcing the new rules.  It would expect oyster producers to use the techniques, especially on oysters harvested in summer months when bacteria levels are higher.  It also issued a background paper on why the techniques are needed, a fact sheet on oyster hazards, and a Q and A on the new policy.

On October 17, FDA official Michael Taylor gave a speech to the oyster industry outlining the policy.

Oops.  The oyster industry did not take well to the idea and went into organized action.

Now, the proposed rules are history.  As the FDA explains:

Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011.  These are legitimate concerns.

It is clear to the FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal.  Therefore, before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way.

My interpretation: 15 or more preventable deaths a year, every year, from oyster Vibrio must not be enough to elicit industry responsibility or FDA action.  That the FDA was forced to back down so quickly is not reassuring about this administration’s commitment to food safety.  Make no mistake.  This is a major setback to developing a strong food safety system.

One of the ironies here is that the FDA’s approach to oyster safety mirrored the approach taken by the very same Michael Taylor when he worked for the USDA in the mid-1990s.  Then, the administration backed him up on requiring science-based food safety procedures for meat and poulty producers.  This time, it looks like the administration pulled the rug out from under him and forced the FDA to back down.

Note: Thanks to Mike Taylor, safety rules are in place for meat and poultry.  Unfortunately, the current USDA isn’t enforcing them.  I will have more to say on that point in tomorrow’s post.

Another note: Center for Science in the Public Interest, which has been pushing for oyster safety for years, has organized a protest campaign.  Sign up here.

The newspapers and the Internet are full of reports that men exposed to bisphenol A (BPA) have higher levels of erectile disfunction.  Before going into a panic, take a look at the study details.   This one was a survey of factory workers in China exposed to exceptionally high levels of this endocrine-disrupting chemical.

What does the study mean for men exposed to much lower levels?  We don’t have a clue.  But we’ve heard plenty of unsettling things about BPA (see previous posts), including accounts by Jill Richardson and others of the extraordinary efforts of industry lobbyists to prevent officials from banning BPA. This new research suggests that a ban is a pretty good idea, even if most people are not harmed by small amounts.

Reasons?

• BPA is not essential in the human diet.
• It is an unnecessary contaminant.
• Small amounts of harmful chemicals can accumulate in the body.
• We have no idea what the threshold for harm might be.
• Removing it from the food and water supply is not all that difficult.

In sum, everyone except makers of BPA plastics can do just fine without it.  I’m stuck; I can’t think of a single reason not to ban it.

Update, November 20: According to reports, NY Senator Charles Schumer has introduced a bill to ban BPA.  The headline of this account says “tabled.”  I think it means “introduced”?

The FDA announced today that it has sent letters to 30 makers of caffeinated alcoholic beverages warning them that caffeine is not approved as an additive to booze:

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS).    FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed….The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.  To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million.  It has not approved caffeine for use at any level in alcoholic beverages.

The FDA asked the companies to provide evidence that the products are safe.  It also opened up a new web page on caffeinated alcoholic beverages.  This gives samples of letters, the list of manufacturers, and letters to FDA from attorneys general and scientists.  There is also a Q and A.  For example:

Q3. What happens if the industry doesn’t share its data in the next 30 days? What options are available to FDA?

A3. If FDA determines that the use of caffeine in an alcoholic beverage is not GRAS or subject to a prior sanction, FDA has a range of regulatory options available to it, from the issuance of a warning letter to seizure. It is the manufacturer’s continuing responsibility to ensure that the foods they market are in compliance with all applicable legal and regulatory requirements. FDA intends to exercise all options that are appropriate for the product in question.

As Michele Simon of the Marin Institute puts it, “It seems the sleeping giant has awaken!

Indeed it does.  You don’t think this counts for much?  Ask the makers of some of these drinks.  A couple of companies already have “voluntarily” removed the caffeine.  I’m willing to bet that others will soon follow?

Thanks to Margo Wootan of CSPI for sending me the text of a speech by David Vladeck, the new director of the Federal Trade Commission’s (FTC) Bureau of Consumer Protection, in which he discusses his agency’s priorities.  One of these is marketing to children.

And about time too.  The last time the FTC wanted to restrict advertising to kids was in 1978.  Then, Congress ridiculed the agency (What?  Restrict free speech?  Horrors!), and promptly passed a law preventing the FTC from taking action.  The head of the FTC, Mike Pertschuk, was fired and that was that (see Giant Killers, for his version of what happened).

Well, times have changed.  Kids are a lot fatter.  Trying to stop relentless food marketing aimed at children now seems like a pretty good idea.  Can’t wait!