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Release of the FDA’s proposals for revisions of the Nutrition Facts label got, to say the least, lots of attention.

A few items need some follow up.

The politics

The best discussion of the First Lady’s involvement in the new food label comes from Helena Bottemiller Evich at Politico:

• On yesterday’s release
• On Mrs. Obama’s emerging role in nutrition policy
• On the likely effects of the new label on the food industry

The reaction of the Grocery Manufacturers Association (GMA)

How’s this for a brilliant response?

We welcome First Lady Michelle Obama’s announcement of the proposed updates to the Nutrition Facts panel and thank her for her leadership on this and broader health issues.  The nation could not ask for a more thoughtful, effective or passionate advocate than Michelle Obama.

For 20 years, the Nutrition Facts panel has been an invaluable tool to help consumers build more healthful diets for themselves and their families, and the time is right for an update.

Diets, eating patterns and consumer preferences have changed dramatically since the Nutrition Facts were first introduced.  Just as food and beverage manufacturers have responded by creating more than 20,000 healthier product choices since 2002, and by providing tools like Facts Up Front front-of-pack labels, the FDA is responding with a thoughtful review of the Nutrition Facts panel.

We look forward to working with the FDA and other stakeholders as these proposed updates to the Nutrition Facts label make their way through the rule making process.

It is critical that any changes are based on the most current and reliable science.  Equally as important is ensuring that any changes ultimately serve to inform, and not confuse, consumers.

How you can file comments

A frustrated reader complains that he can’t find information on the FDA’s website about how to file comments.     That’s because the proposals haven’t been published yet.

They are scheduled for publication in the Federal Register on March 3.  Look for instructions then.  After that, the FDA will collect comments for 90 days.

Two sets of proposed rules will be open for comment:

• Food Labeling: Revision of the Nutrition and Supplement Facts Label  (367 pages)
• Serving Sizes of Foods that can Reasonably be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (145 pages)

Start drafting comments now!

Congress can’t pass a farm bill but it has plenty of time to micromanage nutrition and health.  Buried in the pork-filled Consolidated Appropriations Act of 2014 (see Monday’s post) are some zingers.  Here’s one:

This refers to the ill-fated IWG report I’ve discussed previously. To recap:

• Congress asked the FTC to examine the effects of food marketing to children and make recommendations.
• The FTC, USDA, FDA, and CDC got together and produced a report recommending voluntary guidelines for marketing to children based on the nutritional quality of the foods.
• I thought the guidelines were weak in addition to being voluntary (they allowed lots of junk foods to qualify).
• The food industry disagreed, strongly, and went to Congress to object.
• Congress caved in to industry pressure and said the report could not be released unless the FTC produced a cost-benefit analysis.
• End of story.
• Why Congress feels that it’s necessary to do this again is beyond me.

I suppose we should be glad our legislators are at least doing something.

As for the food industry’s role in all this: when food companies say they are doing everything they can to reduce marketing junk foods to kids, you now know what they really mean.

By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods, energy shots, for example.

Under the law, the FDA pretty much has to keep hands off of supplements, except when something egregious happens, like people getting sick or dying.

The FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs.  It just issued:

• Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages
• Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages

These documents, however, are guidance.  The are not regulations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Why is FDA doing this?  I’m guessing for two reasons.

1.  The weird ingredients in energy drinks:

We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods. 

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.

2.  The high caffeine levels in those drinks.

Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks.

But the levels in energy drinks are so much higher that the FDA has questions about whether GRAS applies to them.

These guidance documents are open for comment.  If you care about such issues, weigh in now.

In the strange way the U.S. government works, Congress has produced the “Consolidated Appropriations Act of 2014,” which authorizes payments for government services, including those related to agriculture.

This is not the farm bill.  It’s what Congress decides taxpayers will pay for in the farm bill as well as bills that cover other programs run by USDA.

The House summary of agriculture appropriations is a lot easier to read than the bill itself, although it contains its share of double speak.  Try this:

WIC – This program provides supplemental nutritional foods needed by pregnant and nursing mothers, babies and young children. The bill provides full funding for WIC at $6.7 billion – $153 million below the fiscal year 2013 enacted level…This level will ensure all eligible participants will be served.

Can someone please explain to me how a cut of $153 million will ensure service to everyone who is eligible?  WIC is not an entitlement; eligible people cannot be served once the money runs out.

The bill does provide full spending—$82.2 billion—for SNAP, but only because it has to.  SNAP is an entitlement and spending for it is mandatory.  Unless, of course, Congress ever passes the farm bill, which currently contains a $9 billion proposed cut.

And here’s more double speak.  “The legislation includes several provisions to reduce spending and increase oversight of taxpayer dollars.”  How?  By authorizing spending for:

• Oversight and monitoring requirements for the WIC program, including a directive for the Secretary of Agriculture to increase oversight of vendors to help rein in food costs;
• A provision requiring USDA to submit a plan for reducing high error rates and improper payments in the National School Lunch and School Breakfast Programs;
• Requirements for the Secretary of Agriculture to help weed out and eliminate waste, fraud, and abuse in the SNAP program – including a directive to ban fraudulent vendors, and a prohibition on advertisements or outreach with foreign governments.

And why does the FDA’s budget still get decided by committees dealing with agricultural appropriations?

The FDA is a public health agency in the Department of Health and Human Services, which is funded by entirely different committees which you might think understand its mission a lot better than committees fussing about legislation that

restricts the Grain Inspection, Packers and Stockyards Administration (GIPSA) from implementing certain regulations that would allow harmful government interference in the private market for the livestock and poultry industry.

I can hardly wait to see what the farm bill will look like.

I’ve written frequently about the “natural” issue—what’s natural in foods and what’s not—on this site and now must do so again.

Yesterday, FoodNavigator reported that the FDA “respectfully declined” to decide once and for all whether foods labeled “natural” can include GMOs.

To summarize what brought this on:

• Judge Yvonne Gonzalez Rogers referred a lawsuit over “all-natural’ claims on GMO-containing Mission tortilla chips to the FDA to decide whether GMO-containing products can be considered “natural.”
• So did two other judges in cases involving Campbell Soup and General Mills Kix cereal.

The FDA’s letter to the three judges says the agency has to make decisions like this in the context of rulemaking, not litigation.

So how about making a decision about what “natural” means once and for all?

Not a chance.  The FDA says it has better things to do:  “Because especially in the foods arena, FDA operates in a world of limited resources, we necessarily must prioritize which issues to address.”

Back to court, this one goes, or so it seems.

The New England Journal of Medicine has an editorial on why we need to stop using antibiotics to promote the growth of farm animals and make sure they are only used for therapeutic purposes.

Otherwise, bacteria will become resistant to them and the antibiotics won’t work in us.

This figure from the article illustrates the problem:

As writers in the Journal wrote a year ago, we know what to do about the problem: Ban antibiotic use for everything other than disease treatment.

The FDA is taking baby steps in this direction.  How about a new year’s resolution to speed up the process?

I was in Washington DC last week when the FDA announced  that it was taking significant steps to address antibiotic resistance, a problem caused by overuse in raising animals for food.

The FDA called on makers of animal antibiotics to:

• Voluntarily stop labeling medical important antibiotics as usable for promoting animal growth or feed efficiency (in essence, banning antibiotics from these uses).
• Voluntarily notify the FDA of their intent to sign on to these strategies within the next three months.
• Voluntarily put the new guidance into effect within 3 years.
• Agree to a proposed rule to require a veterinarian’s prescription to use antibiotics that are presently sold over the counter (the proposal is open for public comment for 90 days at www.regulations.gov.   Docket FDA-2010-N-0155).

Voluntary is, of course, a red flag and the Washington Post quoted critics saying that the new guidance falls far short of what really is needed—a flat-out ban on use of antibiotics as growth promoters.

• Consumers Union is concerned about the long delay caused by the 3-year window.
• CSPI is worried about all the loopholes.
• NRDC thinks the FDA is pretending to do more than it’s really doing and “kicks the can significantly down the road.”
• Mother Jones points out that the meat industry can still “claim it’s using antibiotics ‘preventively,’ continuing to reap the benefits of growth promotion and continue to generate resistant bacteria.”
• Civil Eats reminds us that the Pew Commission on Industrial Farm Animal Production (on which I served) recommended a ban on nontherapeutic use of all antibiotics.

Yes, the loopholes are real, but I view the FDA’s guidance as a major big deal.  The agency is explicitly taking on the antibiotic problem.  It is sending a clear signal to industrial farm animal  producers that sooner or later they will have to:

• Stop using antibiotics as growth promoters.
• Stop using antibiotics indiscriminately, even for disease treatment.

I think the FDA is dead serious about the antibiotic problem.  If the FDA seems to be doing this in some convoluted fashion, I’m guessing it’s because it has to.  The FDA must not have been able to find any other politically viable way to get at the antibiotics problem.

I see this as a first step on the road to banning antibiotics for any use in animals other than the occasional treatment of specific illnesses.

As the New York Times puts it,

This is the agency’s first serious attempt in decades to curb what experts have long regarded as the systematic overuse of antibiotics in healthy farm animals, with the drugs typically added directly into their feed and water. The waning effectiveness of antibiotics — wonder drugs of the 20th century — has become a looming threat to public health. At least two million Americans fall sick every year and about 23,000 die from antibiotic-resistant infections.

Still not convinced antibiotics are worth banning for promoting growth?

The best explanation is the Washington Post’s handy guide to the antibiotic-perplexed.  Here, for example, is its timeline of development of microbial resistance to antibiotics.  The bottom line: the more widespread the use of antibiotics, the greater the onset and prevalence of resistance.  And it takes practically no time for bacteria to develop resistance to antibiotic drugs.

Resources from FDA

• Consumer Update: Phasing Out Animal Antibiotics
• FAQ on today’s action
• Final Non-Binding Guidance for Industry 213
• Veterinary Feed Directive
• Final Non-Binding Guidance for Industry 209

At a talk I gave for CQ Roll Call in Washington, DC last week, an audience member asked about the definition of “natural.”  I thought I had said everything there was to say about it (see post from August).  Wrong.

Another member of the audience sent me the definition of “natural” produced by, of all things, the  Treasury Department’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

Three federal agencies deal with “natural.”

The FDA

In answer to the question, “What is the meaning of ‘natural’ on the label of food?,” the FDA says:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

The USDA

The USDA discusses “natural” in the context of organic foods, in order to distinguish “natural” from organic:

Natural. As required by USDA, meat, poultry, and egg products labeled as “natural” must be minimally processed and contain no artificial ingredients. However, the natural label does not include any standards regarding farm practices and only applies to processing of meat and egg products. There are no standards or regulations for the labeling of natural food products if they do not contain meat or eggs.

The ATF

This agency is in charge of regulating alcoholic beverages, largely for tax-collection purposes.  Its “ATF Ruling 85-4” does not actually define the term “natural,” but instead says when ATF takes no exception to its use.

(1) Any grape fruit, citrus or agricultural wine may be designated “natural” if it is made without added alcohol or brandy…No other type of wine may be designated as “natural.”

(2) A distilled spirit may be designated as “natural” if is solely the result of distillation, with or without mingling of the same class and type of spirits or simple filtration which does not alter the class or type of the product.

(3) A malt beverage may be designated “natural” if it is made without adjuncts (additives) other than those additives which do not remain in the finished product, either by precipitating out or by combining with other components of the product and the resulting compound precipitates or is filtered out.

I am not making this up.

CSPI thinks it’s time to phase out the use of “natural.”  OK by me.

Addition: Michele Simon, who blogs at Eat, Drink, Politics, writes (she’s not making this up either):

In fact, ATF is how housed within the Department of Justice.

Historically, ATF had all jurisdiction over alcohol (and was within Treasury), which is where that rule must have come from.

ATF still maintains jurisdiction over criminal activity, but now, the Alcohol and Tobacco Tax and Trade Bureau oversees labeling. That’s housed within Treasury.

This explains the split in 2002 (click here).

Clear as mud? So maybe you can add a fourth agency to your list!