Search results: fda new food safety rules

On January 1, the USDA’s useless rules for labeling bioengineered (BE) foods, those formerly known as genetically modified (GMOs), went into effect.

Will the new rules help you figure out which items in the produce section or anywhere else in the store have been genetically engineered?

Not a chance.

I am particularly curious about what’s in the produce section.  It’s easy enough to know which genetically modified foods have been approved by the FDA; the FDA has a website for this purpose.

But just because they’ve been approved does not necessarily mean they are in production and in your supermarket.

To know which ones are genetically modified, it would be nice to have labels.

Instead, we have the results of USDA’s obfuscation, as I discussed in a blog post two years ago: Goodbye GMO, Hello Bioengineered: USDA publishes labeling rules.  It’s worth repeating:

NutraIngredients.com had an intriguing (to me, at least) article about the latest complaints about FDA’s lack of action on GRAS ingredients—those Generally Recognized As Safe.

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make changes, the authors found.”

The article referred to a this paper, Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

The starting point for this paper is a study done by the Government Accountability Office (GAO) ten years ago: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS)

The new paper argues that ten years later, the FDA has done little to address the GAO’s concerns.

Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. …most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers…FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

This took me right back to a blog post I did in 2016: The FDA’s unfortunate ruling on GRAS regulations.

Scott Faber, Vice President of Government Affairs for the Environmental Working Group summarizes Trump’s Full-Scale War on Food.  Since taking office, he writes, Trump has:

• Proposed to cut food safety funding for the Food and Drug Administration by $117 million.
• Proposed to cut funding for the Supplemental Nutrition Assistance Program, or SNAP, by $193 billion – a 25 percent cut – and cut international food aid by $2 billion.
• Delayed new labeling rules for menus and packaged foods that would give consumers more information about calories and added sugars, and so far failed to issue a draft rule to implement a new law on disclosing genetically modified ingredients in food.
• Weakened new rules designed to drive junk food out of U.S. schools.
• Proposed to eliminate several Department of Agriculture programs that helped farmers sell directly to local consumers.
• Proposed to eliminate funding for an entire division of the Centers for Disease Control and Prevention that works to reduce obesity.
• Withdrawn new rules to protect drinking water supplies from polluters and proposed cutting the Environmental Protection Agency’s budget by 31 percent.
• Proposed to suspended two of the largest farmland stewardship programs and mothball others.
• Postponed new rules designed to strengthen animal welfare standards on organic farms and proposed to eliminate funding for programs that help farmers switch to organic farming.
• Reversed a ban on a pesticide linked to brain damage in kids and proposed cutting EPA funding for pesticide review programs by 20 percent.
• Punted on new rules to protect farmworkers from pesticides, and proposed to eliminate a program to train migrant and seasonal farmworkers.
• Mothballed new voluntary sodium guidelines that would drive reformulation of foods.
• Called for so-called regulatory “reforms” that would block agencies like the FDA and USDA from adopting new rules designed to keep food safe, update food labels or provide students healthier meal options in schools.

This is an impressive list, calling for serious resistance.

How?  That’s the question….

Several food safety advocacy groups are suing the FDA to take responsibility for ensuring the safety of food additives.

Doesn’t the FDA already do this?  No, it does not.

As the press release puts it [with my emphasis in bold],

Federal law requires FDA to ensure that substances used in food are safe, taking into account consumers’ entire diet and all exposure to the chemical and similar chemicals. But any substance designated as “generally recognized as safe” (GRAS) by FDA or by a food or chemical company can bypass the rigorous pre-market review and approval process applied to food additives. The GRAS exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil, but has been applied in recent practice to novel chemicals and is now a loophole that has swallowed the law.

Under pressure from industry, in 1997 and again in 2016, FDA adopted a practice that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe .

I commented on the FDA’s 2016 ruling at the time.  Former FDA Commissioner David Kessler referred to this GRAS policy as a “joke,” noting that it allows the industry to decide whether its own products are safe.

I am particularly interested in this suit because I wrote a commentary on an article about conflicts of interest in GRAS determinations in 2013.   As I said about the article’s findings,

At present, manufacturers of all food additives are permitted to decide on their own whether a substance is GRAS for human consumption, unless the additive affects food color. Companies also can choose whether to even notify the agency about a new additive. In practice, many manufacturers do inform the FDA. But…about a thousand additives are believed to be in the food supply without the FDA’s knowledge…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.

Let’s hope the lawsuit gets this situation fixed.

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.