Currently browsing posts about: FDA

Listing calories in chain restaurants, you may recall, was authorized by Congress as part of the Affordable Care Act in 2010.

That was an astonishing seven years ago.  In the interim, the FDA wrote regulations, took public comments, rewrote regulations, scheduled them for implementation in 2017, and delayed them until 2018.

New York City, you might also recall, instituted menu labeling in 2008.  The world did not come to an end.

The City said it would go ahead and implement the federal version of the rules as originally scheduled.

The National Association of Convenience Stores objected (the industry has opposed menu labeling from the get go) and went to court to stop the City from doing this.

The FDA—a public health agency, mind you—is supporting industry in this suit.

Even if the City’s characterization of the FDA’s posture as a delay were correct, which it
is not, the City cannot rely upon a supposed void created by the agency to justify its position. As the Supreme Court has made clear, localities may not use the purported “failure of . . . federal officials affirmatively to exercise their full authority” as an excuse to “use their police power to enact a regulation” in a regulatory realm that is otherwise expressly preempted…[New York] may not choose to take its own path in the face of this clear expression of Congressional purpose.

The New York Times wrote about this, pointing out that since most chain restaurants are already in compliance with the law,” what’s the big deal?

I’m quoted:

Marion Nestle, a professor of nutrition and public health at New York University, suggested that the latest delay was part of an industry push under the Trump administration to eliminate the federal menu labeling requirement altogether.

The longer the delay, the more the industry can fight it.

This is a consumer-unfriendly move on the FDA’s part, and not a good sign of what is in store for food politicies under FDA’s jurisdiction.

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.

It’s pretty depressing to watch what’s happening to the gains in food and nutrition policy so hard won in the last few years.

Nothing but bad news:

Menu labeling:  The FDA is submitting interim final rules, a tactic to delay implementation of menu labeling, which was supposed to start on May 5.  Why?  The National Association of Convenience Stores and the National Grocers Association filed a petition asking for the delay.   Pizza sellers have been lobbying like mad to avoid having to post calories.

Food labels (calories, added sugars): As the Washington Post puts it, the food industry is counting on the current administration to back off on anything that might help us all make better food choices.  At least 17 food industry groups have asked for a delay in the compliance date for new food labels—for three years.  Why?  They are a burden to industry.  The soon-to-be FDA Commissioner, Scott Gottlieb, said this about food labels:

As a general matter, I support providing clear, accurate, and understandable information to American consumers to help inform healthy dietary choices,” Gottlieb wrote, according to documents obtained by The Washington Post. “ … However, I am mindful of the unique challenges that developing and communicating such information can pose, particularly on small, independent businesses.”

Definition of dietary fiber: The American Bakers Association wants the FDA to take back its new, stricter definition of dietary fiber, (it excludes synthetic fiber) due to go into effect in July 2018.

School meals: The USDA says it is about to announce new school meal “flexibility” (translation: rollback of nutrition standards).

The score: Big business 4, public health 0

Happy May Day.

For further reading:

• Vox’s Julia Belluz reviews these issues, but also comments on Michelle Obama’s enduring legacy.
• Politico summarizes USDA’s proposed actions.

Addition: It gets worse.  Politico reports that the congressional spending bill:

Contains a rider blocking funds from being used to work on “any regulations applicable to food manufacturers for population-wide sodium reduction actions or to develop, issue, promote or advance final guidance applicable to food manufacturers for long term population-wide sodium reduction actions until the date on which a dietary reference intake report with respect to sodium is completed.”

Politico also points out that the previous draft of the appropriation bill merely encouraged FDA to delay its salt reduction proposal until the reference intake report is updated (this, by the way, will take years).

More documents:

• USDA’ proclamation on school meals
• CSPI’s press release
• Background: the letter from Senator Pat Roberts (R-KS) requesting these changes
• The FY2017 omnibus spending bill that includes the school lunch changes
• RWJ Foundation’s statement

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.”

Two things:

I.  The White House wants the FDA to take a $40 million cut for the rest of this year, according to Politico.  Politico got a copy of a detailed chart given to congressional appropriations committees.  Here’s the FDA piece:

The FDA is supposed to absorb the cut by not hiring people it otherwise planned to.

II.  President Trump has nominated Scott Gottlieb to be FDA Commissioner.  The New York Times describes Gottlieb as a venture capitalist with strong ties to the pharmaceutical and biotechnology industries.

Scientific American summarizes what is known about the nominee, but its discussion is all about drugs and says not one word about food.

If he supports a deregulatory agenda, which it looks like he does, what will happen to inconvenient food regulations such as labels, restrictions on health claims, and food safety?

Let’s keep a close eye on how this one plays out.

I just received this invitation:

Save The Date

FDA invites our Constituent Update subscribers to Save the Date for the

FDA Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food

Thursday, March 9, 2017 (8:30 AM‐5:30 PM)

Hilton Washington DC/Rockville Hotel

 1750 Rockville Pike

Rockville, Maryland 20852

This refers to FDA’s “public process to redefine the healthy” nutrient content claim for food labeling.”

This involved opening its proposals up for public comment, extending the comment period until April 26 this year., and holding this public meeting “to facilitate further dialogue on this topic.”

This all came about as a result of the KIND company’s petition to FDA to advertise its nut-grain-and chocolate bars as “healthy,” even though the nuts and chocolate have more fat than is allowed in the FDA’s current definition.  The FDA agreed that KIND could use the term.

The irony is that this enormous effort applies to processed food products.  OK, some are more processed than others, but eating whole, relatively unprocessed foods is what’s really healthy.

This is about how food companies can market products.  It is not about health.

FDA has produced these documents:

• Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
• Constituent Update: FDA to Redefine “Healthy” Claim for Food Labeling

Remember menu labeling—the amazing number of calories posted on your favorite items at chain restaurants?  For those of you who don’t live in New York City or other places with calorie labels, they are supposedly coming soon to places near you.

Here’s FDA-speak for what is happening:

In December 2015, section 747 of the 2016 Omnibus Bill prohibited FDA from using appropriated funding to implement, administer, or enforce the menu labeling requirements until one year after FDA finalized the draft September 2015 menu labeling guidance. While FDA originally issued a statement indicating the Omnibus Bill extended the compliance date, FDA is clarifying that the compliance date remains December 1, 2016, but, consistent with the Omnibus Bill, FDA will not begin enforcing the final rule until May 5, 2017, which is one year after the date that the Notice of Availability for the final guidance published in the Federal Register.  For more information see: Menu and Vending Machines Labeling Requirements.

Got that?

Really, these are worth waiting for.

Did you really want to eat that 650-calorie muffin?

The FDA wants to tighten up the rules for labels and advertising of “structure/function” claims on infant formulas.  It has proposed “guidance” and asks for comments on it.

This is a good proposal and needs all the support it can get.

Background

“Structure/function” claims were allowed by the Dietary Supplement Health and Education Act of 1994.  These are pseudo health claims that are really about marketing, not health.  Example: this brand of infant formula “supports digestion.”

All infant formulas must meet FDA nutritional requirements and there is no meaningful difference in any of them.  Structure/function claims market one brand over another.  Worse, they make infant formulas seem better than breast milk and help to discourage women from breastfeeding.

In September, the FDA announced that it was proposing draft guidance for industry, entitled “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.”  This says that the infant formula industry must actually produce evidence that the claims do what they say.  Formula makers must substantiate structure/function claims with “competent and reliable evidence,” preferably from clinical research.

Infant formula makers would much rather not bother.

This proposal deserves enthusiastic support.  If you agree with it, please write the FDA and say so.

ChangeLab Solutions has filed a position paper on this topic with the FDA—excellent background reading.

It also has developed a template letter, which you can adapt and send.

But even a shorter statement that you think structure/function claims should not be used to market infant formulas without real science behind them would help.

Here’s the quick one I sent in.  Feel free to copy.  But individual letters carry more weight.

How to do this?

• Go to the FDA docket website: look for ID: FDA-2016-D-2241.
• Go to the first of the two FDA documents listed there.
• Click on “Comment Now!”
• Fill in the Comment box by saying you are commenting on FDA-2016-D-2241.
• Upload your letter
• Following the instructions for the required items (the others are voluntary)

The FDA documents

• FDA announcement
  Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling
• Federal Register Notice