Search results: fda new food safety rules

Here’s what’s come in on Scott Gottlieb’s nomination as FDA Commissioner since my post last week.

From the New England Journal of Medicine: a scathing commentary observes that “Gottlieb’s background places the agency, and the public, in a difficult position.”   Two reasons: (1) “His previous experience in academic medicine, applied science, and government service is threadbare.”  (2) “Gottlieb has been enmeshed in highly remunerative relationships with the biopharmaceutical industry, including sitting on various corporate boards…Gottlieb seems unlikely to have earned his corporate-board perches with scientific expertise.”

From Politico: Gottlieb says he will recuse himself–for one year (that’s all?)–from some (not all?) agency decisions dealing with more than 20 drug companies.  This is because he is a board member or adviser to those companies or funds them through his venture capital roles.  Here is his financial disclosure form.

From StatNews: More details on Gottlieb’s financial entanglements with drug companies: “Gottlieb’s critics argue that his expansive resume creates a conflict-of-interest minefield that could cast doubt on the FDA’s decision making.”

From the New York Times:

Dr. Gottlieb, a resident scholar at the American Enterprise Institute, has also been a prolific writer and public speaker, criticizing the agency’s approach. “In so heavily prioritizing one of its obligations — the protection of consumers — the F.D.A. has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market,” Dr. Gottlieb wrote in 2012 in National Affairs, a conservative-leaning political journal.

Also from the New England Journal of Medicine: A commentary discusses the challenges faced by an FDA Commissioner having to do with evidence for drug efficacy, drug development, and drug prices.  It concludes: “All these challenges require a strongly resourced FDA working at the cutting edge of regulatory science. A commissioner who is able to advocate for such a vision, which includes less dependence on industry funding, will bring the agency into the 21st century.”  Will someone so closely tied to the drug industry fit this description?

Concerns about Gottlieb center on his financial ties to the drug industry.

But what about food?

A reader reminds me about pre-election promises to get rid of the FDA Food Police.

From The Hill, September, 2016:

In a fact sheet posted online Thursday, the campaign highlighted a number of “specific regulations to be eliminated” under the GOP nominee’s economic plan, including what they called the “FDA Food Police.”

“The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food,” it read.“The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperatures and even what animals may roam which fields and when,” the statement continued. “It also greatly increased inspections of food ‘facilities,’ and levies new taxes to pay for this inspection overkill.”

This is one of FoodNavigator-USA’s special edition collections of articles on similar themes, in this case food labeling and lawsuits over labeling issues.  These are a quick way to get up to speed on what’s happening from a food industry perspective .  FoodNavigator introduces this collection:

Food and beverage companies have faced a tsunami of false advertising lawsuits over the past five years. But how big of an issue is this for the industry, who has been targeted, and what strategies are working, both for plaintiffs and defendants in these cases? In this special edition, we also look into labeling issues and trends, from healthy, Paleo and grass-fed claims to NuTek’s potassium salt petition.

• FOOD LITIGATION 101: Are you up to speed?  There have been hundreds of class action lawsuits directed against food and beverage companies in recent years over everything from evaporated cane juice to Non-GMO claims. But has the false advertising litigation trend peaked, and if not, what are the new areas of vulnerability for food companies? .. Read
• More farm-related claims to appear on pack, Innova Market Insights forecasts: Now that clean label has moved on from being a trend to becoming “the new rules of the game,” Innova Market Insights predicts more brands will rely on ‘farm to fork’ claims and bucolic imagery as a differentiator… Read
• Paleo certification requests have doubled annually, scheme embraced by ‘household names,’ says Paleo Foundation: Demand for Paleo-certified products are on the rise. But is the diet – and the certification scheme – based on sound science? We chat with Paleo’s critics and proponents to get the inside scoop… Read
• Dairy from cows fed GM feed is not ‘all-natural’, alleges lawsuit vs Dannon – but will it fly?  Has the FDA’s probe into ‘natural’ claims on food labels put a stop to the tidal wave of false advertising lawsuits engulfing food manufacturers? Not if a new complaint against Dannon is anything to go by, which also delves into the thorny issue of GMOs, another area currently being scrutinized by regulators. .. Read
• Future of Nutrition Facts, menu labeling & food safety are unclear under Trump, CSPI says: While President-elect Trump’s position on food policy is relatively unclear still, changes to the exhaustively researched and intensely debated Nutrition Facts label, menu labeling rule and food safety regulations could all be on the chopping block under the new administration, warns a top nutrition policy expert… Read
• Comments in FDA docket reveals consumers’ shifting perceptions of ‘healthy’: If the FDA’s decision to wade into the ‘natural’ debate seemed like an act of sadomasochism, its decision to re-examine the criteria underpinning ‘healthy’ claims on food labels looks set to be equally painful, judging by the first wave of public comments filed in the docket… Read
• FDA hints at how conventional foods can make structure/function claims: For the first time, FDA weighs in on what marketers must have on hand to support claims about conventional foods’ direct impact on consumers’ bodies. .. Read
• Soup-To-Nuts Podcast:The rise & future potential of grass fed claims: Grass-fed claims on products are a beacon for consumers who are health-conscious, want minimally processed food and care about animal welfare, and as such manufacturers increasingly are using them on products across categories and channels to drive up sales sharply… Listen now
• ProTings closes $1.2m financing round, changes name to Protes after spat with Original Tings: Brooklyn-based pea protein chip pioneer Proformance Foods has closed a $1.2m financing round led by a leading CPG company, and changed its brand name from ProTings to Protes following a trademark dispute with B&G Foods, which owns the Original Tings brand… Read
• Vox Pop: Consumers had this to say about GMO labeling…On the heels of President Barack Obama signing into law a federal bill requiring the disclosure of genetically modified organisms (GMOs) on packaged food and beverage products, we at Beverage Daily and FoodNavigator-USA asked consumers at a downtown Chicago farmers market what they thought of GMOs… Watch now
• Are ‘GMO-free’ (as opposed to ‘non-GMO’) claims legally defensible? As the Non-GMO Project states on its website, ‘GMO-free’ claims are “not legally or scientifically defensible due to limitations of testing methodology” coupled with cross-contamination risks. In future, however, that could change as testing methods become more sophisticated, predicts Clear Labs, a Californian start-up which recently hit the headlines after identifying human and rat DNA in hamburgers [albeit within safe parameters]… Read
• Label Insight: Your SmartLabel landing pages could become more important than your website or facebook pages: While the SmartLabel initiative has been dismissed by some as an elaborate conspiracy by big food companies to avoid mandatory on-pack GMO labeling statements, it will ultimately have far broader significance – and potentially a huge impact on how consumers view all food and beverage products – predicts product data and image platform Label Insight… Read
• House approves federal GMO labeling bill that nullifies Vermont law: The US House of Representatives has voted to pass a federal GMO labeling bill (306:117 votes) that would pre-empt and nullify all state-led GMO labeling laws including the one that has just come into effect in Vermont. .. Read
• Hampton Creek to settle worker classification lawsuit: Just Mayo maker Hampton Creek – one of a growing number of food companies sued for allegedly misclassifying workers as independent contractors as opposed to employees – is settling its case in order to avoid the hassle and expense of protracted litigation, court documents show… Read
• Kellogg, Post & General Mills urge courts to toss ‘meritless’ sugar lawsuits: Kellogg, General Mills and Post Foods have urged the courts to ditch high-profile lawsuits over the sugar content in their cereals, on the grounds that their claims are pre-empted by federal law and that no reasonable consumer would find their labels to be false or misleading… Read
• Dole Foods 9th Circuit ruling reignites all-natural lawsuit, ’emboldens plaintiff’s bar’: The Ninth Circuit Court of Appeals has reversed (in part) a lower court’s ruling that Dole Foods’ ‘all natural fruit’ labeling likely isn’t deceptive, resurrecting a four-year-old lawsuit, and giving fresh ammunition to plaintiff’s attorneys pursuing ‘all-natural’ cases… Read
• Parties clash over Welch’s ‘made with real fruit’ fruit snack label claims: Reasonable consumers may well be misled by the packaging of Welch’s fruit snacks, a magistrate judge has concluded, prompting a lengthy rebuttal from the defendants in court documents filed this month. .. Read
• Shoppers aren’t confused by our labels, Chobani tells court: ‘Plaintiffs count on a consumer who is a veritable fool’: A false advertising lawsuit alleging that Chobani’s labels are confusing and deceptive, paints American consumers as credulous fools unable to apply common sense when they go shopping, argues the yogurt maker in court documents urging the judge to toss the case… Read
• GMA to FDA: Sodium reduction guidance must be re-worded or industry will face a tidal wave of ‘frivolous litigation’: Two years isn’t enough time for food manufacturers to make the kind of reductions in sodium that the FDA is asking for, says the Grocery Manufacturers Association (GMA), which also urges the agency to tweak the wording of its guidance in order to avoid “a wave of frivolous litigation.”.. Read
• American Bakers Association backs ‘potassium salt’ petition: It sounds more clean label: The American Bakers Association (ABA) has joined the CSPI, Unilever, and other food manufacturers in voicing its support for a citizen’s petition asking the FDA to permit ‘potassium salt’ as an alternate name for potassium chloride on food labels, while the Salt Institute remains resolutely opposed… Read

Presidential candidate Donald Trump gave a speech to the Economic Club of New York about his tax reform plan to “make America great again.”

The plan would eliminate some programs he finds annoying, the FDA’s food safety regulations among them.

The tax plan, including the FDA provisions, was posted on Trump’s website, but it is no longer there.

Fortunately, @nycsouthpaw did a screen capture and posted it on Twitter.  Among other things, Trump would like to eliminate:

Food safety lawyer Bill Marler, who begs producers of unsafe food to “put me out of business” is getting his wish and notes how well the new food safety rules are working.  He says Trump must love him: Killing the FDA is good for business:

How did “The Donald” know that my business has dropped over the last few years as the regulatory work of our governmental agencies have kicked into gear.

Who knew that food safety would be an issue in this year’s election, let alone Skittles.

Chase Purdy writing in Quartz says “The system for catching dangerous pathogens in America’s food supply is finally working.”

Here’s the best evidence: the remarkable decline in cases of STEC (Shigella Toxin E. Coli).

Quartz quotes food safety lawyer Bill Marler: “You look back over time and, from 1993-2003, about 90% of my firm’s revenue was from E. coli cases connected to hamburger.”

What changed?  Regulation.

The USDA now considers STEC to be an adulterant and does not permit meat and poultry contaminated with it to be sold.

But then there’s Salmonella.  It is not considered an adulterant.  Why not?  Because it occurs so frequently that USDA considers it normal.  Cases of Salmonella have not declined as much as they should.

In the meantime, the FDA is diligently following through on its food safety rulemaking.  On August 24, it opened three more sets of draft guidance documents for public comment.

• Draft Guidance for Industry #235 – Current Good Manufacturing Practice Requirements for Food for Animals: helps producers of animal feed comply with Good Manufacturing Practice requirements.  And see .  Federal Register Notice for the Draft Guidance for Industry on Current Good Manufacturing Practice Requirements for Food for Animals
• Draft Guidance for Industry #239 – Human Food By-Products for Use as Animal Food: helps providers of byproducts of human food production with how to use them safely in animal feed.  And see Federal Register Notice for the Draft Guidance for Industry on Human Food By-Products for Use as Animal Food
• Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: helps food companies decide if and how FSMA rules apply to their operations.  And see Federal Register Notice for the Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities

FDA officials explain:

When we were drafting and seeking public comment on the rules that will implement theFDA Food Safety Modernization Act (FSMA), we promised that we would do whatever we could to help the regulated industry understand and meet the new requirements….Meeting the FSMA mandate involves cooperation between the FDA and the food industry. From the smallest food operation to the largest company, we want to be sure that we’re all on the same page and these draft guidances will help get us there.

Onward and upward.  This is progress.  It would be nice if it went faster but it’s real progress—even if Bill Marler still has plenty of work to stay busy.

The FDA has announced its Final Rule on Substances Generally Recognized as Safe (GRAS).

The FDA explains:

Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives…The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.

Uh oh.  “Appropriate qualified experts?”  Like those selected by the companies themselves?  The FDA has failed the public on this one.

Consumers Union (CU) says

FDA missed a major opportunity to clean up the food system… Companies will still be able to introduce novel substances into food in secret, without having to show they are safe.  The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients. That is unacceptable and deeply disappointing [CU should know.  It filed comments on the FDA’s proposed GRAS rules in 2011].

Senator Ed Markey (Dem-MA) says

FDA’s Final Rule On Food Safety Process Is A Missed Opportunity…The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take home exam that industry doesn’t even have to hand in…I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply [Sen. Markey sent FDA a letter in April asking if the agency needs statutory authority to ensure the safety of GRAS substances and encouraging the FDA to issue guidance on how to prevent conflicts of interest for outside experts evaluating GRAS substances.

The backstory

The FDA’s final GRAS rule is the result of a settlement agreement following a 2014 lawsuit filed by the Center for Food Safety. The basic issue: GRAS substances are not subject to FDA premarket approvals required for food additives.  Manufacturers are allowed to decide for themselves whether their additives are GRAS without informing the FDA. The new rules confirm this self-managed GRAS notification procedure.

I wrote about this issue in an editorial for JAMA Internal Medicine in 2013 when I commented on a study by Tom Neltner and his colleagues on the blatant conflicts of interest in FDA approval of GRAS substances.

Their study examined conflicts of interest among scientific experts serving on panels deciding whether food additives–substances that preserve, flavor, blend, and thicken food—should be deemed generally recognized as safe (GRAS) and exempt from Food and Drug Administration (FDA) premarket approval requirements.  Their findings are alarming. An astonishing 100 percent of the members of 290 expert panels included in their review worked directly or indirectly for the companies that manufactured the additive in question.  Even more alarming, the experts on these panels form a tight professional cadre.  Although 850 people served on the panels, 10 experts served on 27 panels or more, and one of these ten participated in three-quarters of the panels.

My editorial reviewed the lengthy history of FDA’s dithering about the GRAS process.  None of this would matter if all food additives were safe.  But some are not.  I also pointed out:

The problems created by conflicts of interest for the FDA go well beyond those related to food additives and GRAS exemptions.  A recent analysis of requests for waivers by people serving on FDA advisory committees views conflicts of interest as a severe threat to scientific integrity.  As Neltner et al. argue, the lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, particularly the additives that the FDA does not even know about. It also raises questions about conflicts of interest in other regulatory matters.

The FDA’s decision is a loss for public health.

It constitutes yet another reason not to eat products with long lists of additive ingredients.

Addition, August 16

The Environmental Working Group also issued a statement.

EWG is disappointed the FDA has decided to once again ignore its legal obligation to ensure the safety of our nation’s food supply…The so-called “GRAS loophole” – originally intended to only allow known ingredients proven safe to skip regulatory approval – has swallowed the law, permitting novel chemicals to be added to food without government oversight.

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.

Helena Bottemiller Evich of Politico Morning Agriculture, has produced an alarming investigation of the Obama Administration’s failure to support its own food safety initiatives.  Fortunately, Politico has released it from behind the paywall so it can be read by non-subscribers.  Do read it.  It’s a depressing slice of political reality.

The Obama administration and Congress have all but squandered an opportunity to give the anemic Food and Drug Administration, which is responsible for the safety of 80 percent of the nation’s food supply, a level of oversight the public long assumed it already had.

On paper…the Food Safety Modernization Act…mandated more inspections and much tougher anti-contamination standards for everything from peaches to imported pesto sauce, and it placed more emphasis on preventing outbreaks than on chasing them down after people become sick.

But almost five years later, not one of the sweeping new rules has been implemented and funding is more than $276 million behind where it needs to be. A law that could have been legacy-defining for President Barack Obama instead represents a startling example of a broad and bipartisan policy initiative stymied by politics and the neglect of some of its strongest proponents.

The result is shown in this chart.

She adds: 

The White House has routinely put nutrition policy ahead of food safety, sat on key regulations for months and made only halfhearted attempts to fund the law…Congress, too, bears blame: With no real pressure from the White House or the public, Capitol Hill has given the FDA less than half of what the agency says it needs to actually enforce the new rules, once they take effect.

I’m not so sure about the “putting nutrition ahead” part of this.  Critics have long complained that the White House could have done much more to promote healthier diets.  They recall the lack of support for the Interagency Working Group’s recommendations for nutrition standards for marketing to children.  Menu labeling has just been delayed a year (although advocates tell me that this compromise was necessary to keep labeling for pizza places and movie theaters—ultimately a victory).  

This administration has about a year left to get its legacy in order.  A full-court press in support of the FDA is just what is needed.  Now!

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

FDA’s documents on the gluten-free rule:

• FDA: Gluten-Free Labeling
• FDA: Gluten-Free Labeling Final Rule Q&A
• Consumer Update