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The Center for Science in the Public Interest (CSPI) has sued the FDA for ignoring its 2012 petition to prevent illnesses and deaths caused by eating raw oysters from the Gulf of Mexico contaminated with toxic Vibrio vulnificus.

The lawsuit, filed jointly with Public Citizen, asks the FDA to set standards to make sure these bacteria are “nondetectable in oysters and other molluscan shellfish sold for raw consumption.”

The FDA is supposed to respond to the complaint by July 25.

This issue goes back a long way.  I wrote about it in 2011 in the context of a Government Accountability Office (GAO) report, Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

Vibrio vulnificus bacteria are considered “flesh-eating;” they kill half the 30 or so people who eat contaminated raw oysters.   Treating the raw oysters before allowing them to be sold kills the bacteria.  California requires this and nobody eating California oysters gets sick from Vibrio.  As I wrote in 2011:

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups. If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

So what happened?  Late in 2009, the FDA said it would issue rules, but backed off under pressure from the oyster industry and friendly state officials.

Despite years of warnings and promises that it obviously has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for 15 years at the cost of about 15 preventable deaths a year.

CSPI and Public Citizen are trying the legal route.  I hope it works.

Food Chemical News reports that the Senate Appropriations bill comes with report language instructing the FDA to:

• Conduct a risk assessment to see how harmful it really is to eat Listeria-tainted frozen vegetables [these, presumably, would be cooked before eating].  CRF Frozen Foods had to recall of 358 organic products after 7 people became ill.
• Release no sodium guidelines before the National Academies of Science has a chance to update the Daily Reference Intake (DRI) for sodium [which will take years].  The report says “it is “imperative that any guidance be issued using the latest sound science…based upon an updated DRI report.”  House directives said the same thing.  [The FDA has just released voluntary sodium guidelines for public comment].
• Release its overdue report on food traceability systems: “The Committee directs the FDA to collaborate with science-based international and industry-led food traceability initiatives of the type recommended by the pilot projects…[and] to make publicly available information on FDA’s efforts to encourage…traceability initiatives.”
• Reconsider its E. coli standard.  The Senate views this standard as too stringent and disruptive of raw milk cheese businesses.
• Actively engage stakeholders in best practice standards for medical foods. “They should work together on “forming a framework for a distinct regulatory pathway for medical foods that does not encumber its progress towards approval for patient use.”
• Better enforce standards for antibiotics in shrimp imports.
• Sample olive oil bottles at retail to determine if they are adulterated, and report findings to Congress.
• Report on efforts to implement regulations for the growing commercial human milk industry.

Some of these directives would improve food safety, but some would not.

All make more work for the FDA.

Does the Senate also plan to appropriate sufficient funds for the FDA to do all this in addition to what it is already doing?  Want to take bets?

Yesterday, the FDA opened for public comment its long-awaited guidance for industry about reducing salt in processed food products.  The guidance affects about 150 products.  It gives baseline data for those products and sets targets for salt reduction.

Please note that I am using the word salt, not sodium.  The targets are for sodium reduction.  Most dietary sodium comes from salt added to processed foods and pre-prepared foods.  Salt is 40% sodium.  The target dietary intake of 2300 mg sodium comes to just under 6 grams of salt a day, which is not particularly low.  It is, however, lower than current intake levels.

In a blog post, FDA official Susan Mayne said the link between sodium intake and blood pressure is “strong and well documented,” but

In fact, it’s very difficult in the current marketplace NOT to consume too much sodium. The average intake today is over 3,400 milligrams—significantly more than the 2,300 milligram limit recommended by federal guidelines. And it’s not just adults who are eating too much sodium: Children and teens consume more than is recommended.

Vox, for example, provides a terrific chart on the amounts of sodium in foods.  It starts with this:

Susan Mayne goes on to explain that

the FDA assessed the sodium content of thousands of products in the marketplace and engaged with experts in industry, academia, and government to get the best available scientific and technical input. We know that sodium has important functions in many foods, such as taste, texture, and microbial safety… Our approach encourages gradually reducing sodium in the majority of foods that contain it…Moreover, our draft targets apply to processed and prepared foods that are eaten both at home and outside the home.

Despite the voluntary nature of the guidance and the lengthy timeline (up to ten years) for implementation, the makers of processed foods are sure to object.  At their urging, the House committee on appropriations, in draft report language, urged the FDA to postpone guidance on salt until the CDC and Institute of Medicine update the Dietary Reference Intake standards for sodium intake.

The Salt Institute, the trade association for the salt industry, issued a press release charging malpractice:

The issuance today of new “voluntary” sodium reduction mandates by the FDA is tantamount to malpractice and inexcusable in the face of years of scientific evidence showing that population-wide sodium reduction strategies are unnecessary and could be harmful. This effort will limit the food choices of Americans, not increase them as the FDA claims. It will make our food less safe and endanger public health.

In JAMA, CDC Director Thomas Frieden rebuts the scientific arguments point by point and, in my view, demolishes them.  He explains how important this initiative is to public health:

Thirty-nine countries have established sodium targets for foods and meals, with 36 of those adopting voluntary approaches. Setting targets helps create a level playing field for the food industry, supporting reductions already begun by companies such as Walmart, Darden, Unilever, PespsiCo, General Mills, Mars, Nestlé, and others. The United Kingdom set voluntary sodium reduction targets in 2003; from 2003 to 2011 sodium intake decreased 15%. During this same period, average blood pressure decreased, and, following no change in prior years, deaths from ischemic heart disease and stroke decreased by approximately 40% [the reference for this last statement is BMJ Open. 2014;4(4):e004549].

Most people would be healthier cutting down on salt intake.  Food company executives know this.  Politico Morning Agriculture points out that some Big Food companies have joined the public health community in supporting the FDA’s proposal.

The band of strange bedfellows – the American Heart Association, Mars, Academy of Nutrition and Dietetics, Nestlé, PepsiCo, American Public Health Association, Unilever and the Center for Science in the Public Interest – all signed on to a letter last month to Senate Appropriations ag subcommittee Chairman Jerry Moran and ranking member Jeff Merkley to support the FDA on sodium. Find that here.

From a public health perspective, the FDA initiative is a step in the right direction but could go further.  It should have required mandatory salt reduction.  Judging from the Salt Institute’s reaction, this is still a big step.  The New York Times quotes Michael Jacobson:

“The F.D.A. found a sweet spot between doing nothing and regulating…This will at least give the public benchmarks against which we can gauge sodium content of foods.”

FDA resources:  

• Federal Register Notice.  The home page explains how to submit comments by October 31 to Docket No. FDA-2014-D-0055
• Draft Guidance Document in PDF (132KB)
• Draft Food Categories and Draft Voluntary Targets for Sodium Reduction (Appendix Table 1) (XLSX: 43KB)
• Summary Explanation of the Draft Food Categories and Draft Voluntary Targets for Sodium Reduction (Appendix Table 1) (PDF: 277KB)
• Sodium Reduction At A Glance
• Presentation: FDA’s Voluntary Sodium Reduction Initiative (PPTX 3MB) 
• Constituent Update: FDA Issues Draft Guidance to Industry for Voluntarily Reducing Sodium
• Blog: Reducing Sodium in the Food Supply
• At a Glance: Lowering Sodium in the Food Supply
• Frequently Asked Questions on FDA’s Sodium Reduction Strategy
• Additional Information and History of Actions on Sodium Reduction

The FDA issued its final rules for the Nutrition Facts panels, but now I want to know: What ever happened to its front-of-package (FOP) initiatives?

The New York Times editorial on the new food label raised this very question.

But the labels, which most food companies will have to use by July 2018, still have serious limitations. They require busy shoppers to absorb a lot of facts, not all of which are equally important, and then do the math themselves while standing in the grocery aisle. And the labels are on the back of the package, where only the most motivated shoppers will look.

The editorial refers to the FDA’s front-of-package initiatives early in the Obama administration.  These involved two reports from the Institute of Medicine.  The first, released in 2010, examined about 20 existing front-of-package schemes cluttering up the labels of processed foods and evaluated their strengths and weaknesses.  It recommended that FOP labels deal only with calories, saturated fat, trans fat, and sodium.  My question at the time: why not sugars?  The committee’s answer: calories took care of it.

But the IOM’s second report in 2011 included sugars and recommended a point system for evaluating the amounts of it and those nutrients in processed foods.  Packages would get zero stars if their saturated and trans fat, sodium, or sugars exceeded certain cut points.

The Times editorial explained what happened next:

the Grocery Manufacturers Association [GMA] called the Institute of Medicine’s recommendation “untested” and “interpretive.” Along with the Food Marketing Institute, it developed its own front-of-package labeling system, which includes some useful information, but is more complex and less helpful than the institute’s version.

As I stated at the time, the FDA let the GMA get away with this and has said not one more word about front-of-package labels.

According to the Times, the FDA is still studying the matter.

it’s not clear when or if the agency will require front-of-package labels. The food industry, of course, wants to make its products appear as healthy as possible. The F.D.A. would serve consumers best by taking the Institute of Medicine’s good advice and putting clear and concise nutrition labels right where most shoppers will see them.

It certainly would.  It’s time to take those IOM reports out of the drawer and get busy writing rules for them.

Guest Blog

The FDA’s new rules for food labeling are finally here

The changes are a step toward better health and less obesity, especially in children

By Marion Nestle on May 24, 2016

The FDA’s announcement of final rules for its overhaul of labels on food packages is a signature accomplishment of Michelle Obama’s Let’s Move! campaign to end childhood obesity within a generation.

In 2010, in setting the agenda for Let’s Move!, the White House Task Force on Childhood Obesity called for improving the clarity, accuracy, and consistency of food package labels to enable parents and children to make healthier food choices.  The Task Force noted that more than half the adult public used food labels to decide what to buy, but that the current labels had hardly changed since the FDA’s regulations of 1993.

The FDA actually began work on revising the food label in 2005 with a request for public input on updating serving sizes, and it began formal rulemaking in 2008.  The FDA proposed rules and issued its last call for comments in 2014.

I attribute this nine-year process to details and politics.

First, the details. The Federal Register notice on the food label takes up 943 pages, and it takes another 170 pages to explain the changes in serving sizes.

FDA’s fact sheet on the changes explains the politics.  Most changes are relatively uncontroversial: the greater emphasis on calories, the removal of calories from fat, the requirement for “dual column” labels for “per serving” and “per package,” the updating of serving sizes to more closely reflect actual intake, and the rewording of the Daily Value footnote.  As Michelle Obama put it, ”you will no longer need a microscope, a calculator, or a degree in nutrition to figure out whether the food you’re buying is actually good for our kids.  So that’s a phenomenal achievement.”

Indeed it is, especially in light of a political climate in which the food industry and Congress do all they can to undermine public health measures in school food and child nutrition programs.

Mrs. Obama alluded to the ongoing political controversy: “most important of all, this label will tell you how much sugar in your snack was added during processing, and how much of it comes from ingredients like fruit.”

The new food label distinguishes between intrinsic sugars in food and those added in manufacturing; it also sets a Daily Value for the maximum amount of sugars recommended for diets of 2,000 calories a day.  I credit the Center for Science in the Public Interest for this accomplishment; it petitioned FDA for these changes in 2013 (its first added sugar petition was in 1999).

The Washington Post got right to the core of the controversy: “Why the sugar industry hates the FDA’s new Nutrition Facts label.” Americans consume roughly twice the amount of sugar recommended for good health, and sugars are rampant in processed foods.  All it takes is one 16-ounce soft drink to reach the 50-gram daily maximum.

The Sugar Association, the trade group for producers of sugar cane and sugar beets invokes science as the reason for its intense opposition: “We are concerned that the ruling sets a dangerous precedent that is not grounded in science, and could actually deter us from our shared goal of a healthier America.”

The Association argues, correctly, that the sugars that occur naturally in fruits are biochemically identical to those added in manufacturing.  But this argument misses how added sugars dilute the nutritional value of food products.  Much research supports the health benefits of eating fruit, whereas added sugars raise risks for obesity and other chronic conditions.

The Sugar Association does not really care about science.  It cares about what will happen to sales if people read labels and reject products with added sugars.  This, of course, is one of the purposes of Added Sugars on food labels.

The Association has reason to worry.  Since 1999, per capita consumption of sugars has fallen in the United States, although it still exceeds the 10 percent of calories recommended by the World Health Organization last year.  The new label should accelerate that downward trend.

An even greater worry is that labeling added sugars might encourage manufacturers to reduce the amounts in their products.  The FDA’s listing of trans-fatty acids on food labels in 2006 led to an immediate reductionin the use of hydrogenated oils as ingredients in food products.  I expect to see grams of sugars decline by the time these rules take effect in May 2018 (small food producers get until May 2019).

I see the new label as a political win for public health and Let’s Move!  But let’s keep this in perspective.  Healthful diets are based on foods, not food products.  We would all be healthier eating foods that do not come with Nutrition Facts panels, and saving most of those that do for once-in-a-while occasions.

The views expressed are those of the author(s) and are not necessarily those of Scientific American.

Recent Scientific American Articles by Marion Nestle

• What Science Says about Eating Right
• Eating Made Simple

The terms “healthy” and “natural” help to sell food products.  They are about marketing, not health.

This makes life difficult for the FDA, which has the unenviable job of defining what the terms mean on food labels.

In a victory for the maker of KIND bars, the FDA has just said that the bars can be advertised as healthy—and that the agency will be revisiting its long-standing definition of the term.  This is what that definition says now:

You may use the term “healthy” or related terms as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the conditions for total fat, saturated fat, cholesterol, and other nutrients…In addition, the food must comply with definitions and declaration requirements for any specific NCCs [Nutrient Content Claims].

The chronology :

• March 2015: FDA issues a warning letter to KIND stating that product labels make nutrient content claims without meeting the requirements for making such claims.
• December 1, 2015: KIND files citizen petition asking FDA to permit use of “healthy” because nuts, even though higher in fat than FDA permits, are healthy.
• April 20, 2016: FDA says KIND products now meet labeling requirements
• May 10, 2016: KIND announces that the FDA has reversed its stance and will allow it to use “healthy.”

As reported by Food-Navigator-USA (in a remarkably thorough account of these events),

Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition at the FDA, said: We do not object to the specific statement that you would like to place on your bar wrappers, on the condition that there will be no other nutrition-related statement, such as express or implied nutrient content claims, on the same panel of the label…We agree with you that our regulations concerning nutrient content claims are due for a reevaluation in light of evolving nutrition research.”

What this sounds like is that FDA will be soliciting comments on the meaning of “healthy.”   It also sounds like the FDA agrees that fat is not an appropriate criterion.  But will the FDA set a limit on sugars?  KIND bars are sweetened.

This looks like the FDA will request comments as the start of its interminable rulemaking process.

In the meantime, here’s the Wall Street Journal’s video explanation of the absurdity of the current rules.

Natural

The FDA is further along in that process for “Natural.“  The comment period closed and Politico Pro Morning Agriculture reports that more than 5000 came in.  These have not yet been posted, but Morning Ag has some.  It says opinions vary.  Widely.

• FDA should prohibit using the term.
• Acceptable post-harvest processing and production methods [including GMOs]
• No chemicals, no additives, and no kitchen chemistry
• Some forms of processing can be used – and indeed may be necessary.
• ‘Natural’ means that this product contains no artificial or synthetic ingredients.

I’ve commented many times in the past on the ongoing debates about “natural.”

I repeat: When it comes to food labels, “healthy” and “natural” are marketing terms.  Their purpose is to sell food products.

Caveat emptor.

Mars, the very same company that has been trying for years to position chocolate as a health food, appears to be joining the food movement, and big time.

Take a look at its GMO disclosure statement on the back of this package of M&Ms.

If it’s too small to read, the statement is in between MARS and the green Facts Up Front labels)

PARTIALLY PRODUCED WITH

GENETIC ENGINEERING

And this is before Vermont’s GMO labeling rules come into effect in July.

Mars also has come out in support of the FDA’s proposals on voluntary sodium reduction.  The company explains that through its “new global Health and Wellbeing Ambition,

Mars Food will help consumers differentiate and choose between “everyday” and “occasional” options. To maintain the authentic nature of the recipe, some Mars Food products are higher in salt, added sugar or fat. As these products are not intended to be eaten daily, Mars Food will provide guidance to consumers on-pack and on its website regarding how often these meal offerings should be consumed within a balanced diet. The Mars Food website will be updated within the next few months with a list of “occasional” products – those to be enjoyed once per week – and a list of “everyday” products – including those to be reformulated over the next five years to reduce sodium, sugar, or fat.

Last year, the company supported the FDA’s proposal to require added sugars labeling with a Daily Value percentage on the Nutrition Facts panel.

It also said it would stop using artificial dyes in its candies.

How to interpret these actions?  I’m guessing they mean that the movement for good, clean, fair food has gained enough traction to put long-established food brands on notice: make your products healthier for people and the environment, or else.

Yesterday, the House Appropriations Committee passed the 2017 Agriculture-FDA spending bill.

As Politico explains (behind a paywall, unfortunately)

The bill would boost funding for rural development to $2.9 billion and allocate an additional $33 million over fiscal 2016 levels for the FDA to carry out the requirements of the Food Safety Modernization Act.

This isn’t nearly enough to permit FDA to carry out its functions.

The committee also passed amendments to:

• Block the USDA from carrying out rules to protect chicken farmers with contracts with processing companies (they own the birds).
• Exempt e-cigarettes from FDA regulations that restrict e-cigarettes advertising.

Can someone please explain to me why agricultural appropriations committees have jurisdiction over FDA and FDA spending is linked to agriculture spending?  OK, this is an historical anomaly; the FDA used to be part of USDA, but that was nearly a century ago.

Today’s FDA is part of the public health service, along with the CDC.

Shouldn’t health committees decide how much funding should go to FDA’s mandate to protect public health?

Just asking.