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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!

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 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?

Big news!  According to an AP report today, the group that runs the Smart Choices program has announced that it will “postpone” active recruitment of new products and will not encourage use of the logo while the FDA is in the process of examining front-of-package labeling issues.

Who says the FDA does not have any power?  I think it does.  And let’s welcome it back on the job.

As for my nutrition colleagues in the American Society of Nutrition, the group that competed to manage the program and has been defending it ever since, here’s what they now say:

Dear ASN Member,

Today the Smart Choices Program announced the decision to voluntarily postpone active operations and not encourage wider use of the Smart Choices Program logo. This move follows an announcement by FDA Commissioner, Margaret Hamburg, M.D. on Oct. 20, 2009, which said that the agency intends to develop standardized criteria on which future front-of-package (FOP) nutrition or shelf labeling will be based. In a letter captioned, “Guidance for Industry” and posted on its website, the FDA stated: “We want to work with the food industry − retailers and manufacturers alike − as well as nutrition and design experts and the Institute of Medicine, to develop an optimal, common approach to nutrition-related FOP and shelf labeling that all Americans can trust and use to build better diets and improve their health.”

ASN commends the FDA on its announcement of intent to develop standardized criteria on which front-of-pack nutrition and shelf labeling could be based. In addition, ASN fully supports the decision of the Smart Choices Program Board of Directors to postpone their active operations as FDA works to address both front-of-pack and on shelf labeling.  “ASN will continue to provide nutrition science expertise within the dialogue on front-of-pack labeling in order to best serve the interests of the health of Americans,” said ASN President Jim Hill in a statement to media.

Sincerely,

ASN Executive Board

As I have explained in previous posts about Smart Choices, the ASN should never have gotten involved in this dubious enterprise in the first place.  The organization was lucky to get out of this so easily.  I hope it does not make the same mistake again.

The press had a field day with the Smart Choices logo on Froot Loops.  As Rebecca Ruiz at Forbes puts it, “the uproar over the program has conveyed a definitive message to industry: Don’t try to disguise a nutritional sin with a stamp of approval.”

The FDA has a new “Dear Industry” letter announcing that it is going to set some rules for those “better-for-you” stickers on the front of junk food packages.  Why?   “FDA’s intent is to provide standardized, science-based criteria on which FOP [front of package] nutrition labeling must be based.”

What this is about, of course, is all those self-endorsement labels food companies like PepsiCo (Smart Spot),  Kraft (Sensible Solution), and many companies collectively (Smart Choices) have been putting on their products.

The companies set up their own nutrition criteria and then applied those criteria to their own products. Surprise!  A great many of their products qualified for the “better-for-you” labels.

I’m guessing Smart Choices was the final straw for the FDA. The idea that the Smart Choices check mark could go onto Froot Loops was so astonishing, and the subject of so much ridicule, that the FDA had to act.  If nutrition criteria are developed independently, most junk foods would not qualify.

The FDA also says it will be testing how well consumers understand different kinds of package labels.  It gives a bunch of examples.  Want to know how the FDA is thinking about this?  Check out its handy backgrounder, which if nothing else is an excellent introduction to the entire issue of front-of-package labels.

Have a preference about what to use?  Write the FDA at this address:

Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the title of the guidance document: Guidance for Industry: Letter Regarding Point of Purchase Food Labeling.

Addendum, October 22: Here are two additional documents to add to the collection.  First, a letter to representative Rosa DeLauro responding to her complaint about the Smart Choices program.  Second, is a a summary of the talking points used by Commissioner Margaret Hamburg in her press conference on the new FDA initiatives.   My conclusion:  the FDA is back on the job!

Ah those British.  So ahead of us in so many ways.  A professor in Aberdeen had the nerve to suggest that supplements don’t make healthy people healthier.  The industry reacted accordingly. More interesting is the expectation that sales of vitamin and mineral supplements are expected to drop by 50% in the near future.  Imagine: the British don’t think they do much good.

But maybe Americans don’t either?  The September issue of Nutrition Business Journal (NBJ) is full of doom and gloom.  The FDA wants to regulate supplements.  Congress is rethinking the Dietary Supplement Health and Education Act of 1994 (DSHEA) – the one that deregulated the industry.  Today’s New York Times discusses congressional hearings about problems with sports supplements that contain steroids but don’t say so.

So maybe DSHEA wasn’t such a great idea.  Sports supplements and those for weight loss are getting bad press for the harm they cause.   Coupled with the economic downturn, none of this is helping sales.  NBJ says last year’s 5% growth in supplement sales is the lowest since 1997 and predicts that next year will be worse.

Why?  As NBJ explains, it gets letters from doctors saying things like this: “I’ve become stronger in my conviction that taking supplements is nothing more than a giant crapshoot.”

This, I argue, is the entirely predictable result of deregulation.  The supplement industry worked relentlessly to get itself deregulated.  It even wrote the language of the bill that Congress eventually passed (I describe this history in detail in Food Politics).  This industry is now facing the consequences of its own actions.

How ironic that supplement makers will be begging the FDA for regulation if for no other reason than to gain some trust.

I like yogurt.  But do probiotics – those “friendly” bacteria in yogurt and  increasingly added to other foods – do anything for you beyond making yogurt taste good?  I wrote about probiotics in What to Eat at some length.  Tara Parker-Pope has a quick summary of the state of the research in today’s New York Times.

The quick answer is mixed.  It includes a lot of  “maybe” or “probably,” always a sign that whatever probiotics might do isn’t going to be much.  The answer is probably yes for infant diarrhea and, maybe, irritable bowel syndrome, and maybe or no for just about everything else.

In the absence of FDA action to regulate misleading health claims, lawyers have jumped into the breach.  They have just won a large class-action settlement – $35 million – against Dannon for claiming that Activia yogurt promotes immunity.   According to one news account, Dannon spent $100 million marketing the immunity-promoting effects of Activia ignoring the results of its own company-sponsored research which inconveniently showed few benefits.  (Did they not pay enough for the research?).

Dannon is working hard to get an approved health claim from the European Standards Agency which annoyingly wants to see some science behind health claims before approving them.  Dannon has now added a tomato extract to its yogurts with the idea that this substance, which appears to help deal with diarrhea, will strengthen its bid for a health claim.

Probiotics are another reason why the FDA needs to set better standards for health claims.  If it were up to me, food packages would have no claims on them: none at all.  Foods are not drugs.

And here’s another reason why:

Will Cocoa Krispies  be the next target of those pesky lawyers?

FDA: get to work!

Three items on the Smart Choices front (make that four – see below):

1.  Let’s start with the great video by ABC News [if the link doesn’t work, go to the ABC News site and search for Food Label Fight].  It features an incredulous Mark Bittman pulling check-marked products off supermarket shelves, along with Richard Kahn defending the program.  Kahn, as I discussed in What to Eat, defended the American Diabetes Association’s (ADA) implied endorsement of Post sugary cereals.  When Jane Brody wrote about this in the New York Times, the Association promised to remove its logo from the products and did so after a bit.

2.  The letter-writing campaign organized by Change.org has had the same effect: “Victory: Change.org Members Force Health Organizations to Back Away from Food Labeling Ploy.”

The new marketing program, called “Smart Choices,” is a front-of-the-package nutrition-labeling program designed in theory to help shoppers make smarter food choices.

But as the New York Times exposed last week, the selections are anything but healthy. One of the selections is Froot Loops, which was chosen, according to one board member, because “it’s better for you than donuts.” (No, we’re not kidding. We couldn’t make this up.)

Despite the program’s dubious standards, it maintained the appearance of legitimacy because researchers associated with three reputable organizations – American Diabetes Association, American Dietetic Association, and Tufts University – were on its board.

In response, thousands of Change.org members sent letters to the presidents of these three major research institutions urging them to remove their name from the program.

The result? All three organizations responded to the pressure this week by publicly distancing themselves from the food labeling scheme and officially asking Smart Choices to remove their name from its website and marketing materials – thereby publicly embarrassing and discrediting the program.

Fine, but this one isn’t over until the American Society of Nutrition (ASN) also extricates from its commitment to manage the program – a clear conflict of interest.

3.  The Institute of Medicine (IOM) is asking for nominations to a committee to study front-of-package labeling (what follows is edited from the request letter):

The IOM is searching for experts in the scientific, technical, and medical professions to be considered for a study committee titled Examination of Front of Package Nutrition Rating Systems and Symbols (Phase I). The sponsors are the CDC and FDA.   The Phase I committee will undertake a review of front-of-package nutrition rating systems and symbols…[and] will also plan for a Phase II.

Phase I will (a) identify front-of-package systems being used, (b) consider their purpose and overall merits, (c) identify the criteria underlying the systems and evaluate their scientific basis, (d) consider advantages and disadvantages, (e) plan Phase II which will consider the potential benefits of a single, standardized front-of-package food guidance system regulated by FDA (my emphasis).

Send the names of candidates to front-of-pack@nas.edu by October 5, 2009. You do not need to contact the individuals you nominate.

This is great news but I’m way too impatient.  This two-phase process will take years. Is the FDA really going to have to wait that long to take action on front-of-package labels such as Smart Choices?

FDA: How about issuing a moratorium on all front-of-package labels until the committees do their work?

4.  Update, September 24: On that very issue, Congresswoman Rosa de Lauro has asked the FDA to do an investigatation of the Smart Choices program.  Excellent idea!