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I received a flurry of “you should have attended the meeting before you said anything” messages in response to my post yesterday about the FTC forum.  They said the table that I posted did not have footnotes attached and I also had missed a key point about RACC (reference amounts commonly consumed): they are likely to be larger than current FDA serving sizes, meaning that the amounts of sugars and salt will have to be reduced to qualify.

Guilty as charged.  RACC, as I mentioned yesterday, is a new term to me.  This is because – how could anyone have missed this – I was unaware of the FDA’s Federal Register notice of April 4, 2005: “Serving sizes of products that can reasonably be consumed at one eating occasion; Updating of reference amounts customarily consumed; Approaches for recommending smaller portion sizes.”

This notice was the result of concerns about the serving sizes that had been established when the FDA issued final food labeling regulations in 1993.  Then, the FDA established serving sizes for 129 product categories for adult foods and 11 categories for infant and toddler foods.  These were derived from information about amounts commonly consumed reported in food consumption surveys from the late 1970s and late 1980s.

Either people ate a lot less back then or they were lying, or both.  As my former doctoral student, now Dr. Lisa Young, discovered during her doctoral research, standard portion sizes – half a cup of ice cream or one 2 or 3-ounce slice of pizza, for example – are smaller (sometimes much smaller) than what people seem to be actually eating.

The FDA knew this.  In 2003, it appointed an Obesity Working Group to advise the agency about several issues, among them whether to update the RACCs.  The Group filed its report in 2004.  With respect to serving size, it recommended:

* In the short-term, that FDA encourage manufacturers immediately to take advantage of the flexibility in current regulations on serving sizes that allows food packages to be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.

* In the long-term, that FDA develop two separate ANPRMs [Advance Notice of Proposed Rulemaking].  The first would solicit comment on whether to require additional columns within the nutrition label to list the quantitative amounts and %DV of the entire package on those products and package sizes that can reasonably be consumed at one eating occasion or, alternatively, declare the whole package as a single serving. This ANPRM would also solicit information on products and package sizes that can reasonably be consumed at one eating occasion.  The second ANPRM would solicit comments on which, if any, RACCs of food categories appear to have changed the most over the past decade and therefore need to be updated.

On that basis, the FDA’s 2005 Federal Register notice asked for comments about whether:

• Consumers might “think that an increase in serving size on food labels means more of the food should be eaten.”
• Manufacturers might repackage products in larger sizes to avoid labeling a package as a single serving.
• Manufacturers might reduce the size of single-serving packages to reduce the apparent content of undesirable nutrients.

That was nearly five years ago.  If anything further happened, I cannot find it in the Federal Register. Getting to these questions at last was apparently the point of the FTC forum.

I am told that panelists suggested raising the RACC serving size of kids’ cereals to 50 grams rather than the current 30 grams.  If so, this would require cereal companies to reduce the amount of sugars in their products.   Aha!  That could explain why, as I discussed in a previous post, General Mills chose to put its full-page ads in newspapers promising to drop the sugars to single digits.  General Mills must think changes in the RACC for cereals will require it to lower the sugars in order to be able to advertise to kids under the voluntary guidelines. Given how long the FDA’s processes take, it is understandable why General Mills failed to say when it would implement its promist.  I am also told that the salt cut-point is open for comment.

For those of us who were not at the Forum and prefer to see such things in writing, how about releasing the footnotes to that chart and giving us some examples of the proposed changes to the RACC?  Also, how about setting up a mechanism so interested people can file official comments on the proposals?  Both would help people offer more informed comments on how the FDA should handle the serving size issues.

Update, December 20: Thanks to Ellen Fried for providing a link to some food industry opinion on what all this is about and another an in-the-know source that says the proposed standards are to be published in the Federal Register and opened for further public comment in January.  The project is to be finished by July.  Ellen points out that this procedure seems administratively complicated for standards that are not regulations; they are voluntary. Do the FTC and FDA really have to go through all this to issue what is simply guidance?  Or is something else going on here that I’m not getting?

After years of complaints about how hard it is to get information about pet food recalls, the FDA’s Center for Veterinary Medicine has  taken a big step to solve the problem.  It just posted a new widget for pet health and safety.  Technophobic dinosaur that I am, I can’t figure out how to load it.  I went to the link above, copied the code, and pasted it, but I can’t get the cute web gadget to display.  All that shows on my screen is a link to the site.

The FDA hosted a webinar on Tuesday about how to use it.  Alas, I was off giving lectures and couldn’t tune in on it, but the FDA posted the conversation on the website.

Gina Spadafori at Pet Connection was on the call, has much better technical skills than I do, and managed the upload.  She talks about how the FDA has “gone all widgety” and has some cautiously optimistic things to say about it.

This web gadget ought to make it easy for FDA to give the pet community straight information about foods recalled and not.  And anyone who wants to track this sort of thing can look it up on the site or, maybe, download it.  Good idea!  Cheers to the FDA!  And let’s hope the FDA uses is early and often.

Front-of-Package Labels: The FDA is hard at work trying to do something about public understanding of food labels.  What with the fuss about the Smart Choices program (now withdrawn), FDA wants to get the front-of-package labeling under control.  It is considering various formats for giving a quick overview of the nutritional quality of food products.  FDA is asking for public comment on the various formats (see Federal Register notice).

The FDA chose five versions (plus variations) for comment:

1. A mini Nutrition Facts version called Nutrition Tips
2. A UK traffic lights version
3. A version like Hannaford’s Guiding Stars
4. A version like the discontinued Smart Choices
5. One that just highlights calories/servings

I rather like this one, a variation of #1 (colorful, easy to understand, not too cluttered, and makes calories clear).

The Nutrition Facts Panel: The FDA also is taking another look at the Nutrition Facts panel on the back of food packages.  It is seeking public comment on  a plan for consumer research to test understanding of elements on the Nutrition Facts panel.  Here’s the Federal Register notice with all the information about what’s going on and where to file comments.

What’s interesting about this is that the FDA has great social science researchers on staff.  They’ve been kept under wraps the last eight years and apparently are being let loose again.  Even so, they don’t get to just go out and do studies like we academics do (with human subjects approval, of course).  Oh no.  First, they have to announce that they plan to do the studies (which they did some time ago) and get comments on the idea.  Then they do the research plan and have to ask for further comments on the research design.  That’s what this notice is about.  Once they deal with these comments, they can finally get to work.    It’s a miracle if they do anything at all.  Keep them busy: send comments!

Agency Transparency: The Association of Health Care Journalists (ACHJ) and ten other journalism organizations have filed a complaint.  The FDA, they say, is still requiring journalists to obtain permission from an agency official in order to conduct interviews with staff members.  This is a leftover from the Bush administration.  Time to get rid of it.

Blogging: It is especially time to open up to reporters because Michael Taylor, who is now senior advisor to the FDA commissioner, is now blogging on the Atlantic Food Channel (which also reprints my posts).  If he can blog, FDA staff can talk to reporters.

Addendum: Beverages pretending to be dietary supplements: The FDA has just issued guidance to the beverage industry to stop putting herbal supplements into beverages and calling them dietary supplements so they can get around food rules on health claims.  If a beverage is consumed as a food, it should be labeled as a food.  Guidance, of course, is non-binding but I see this as a warning that the FDA is going to be enforcing its own rules.  Good show!

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!