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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

I am late getting to the FDA’s July announcement of the release of its work plan for the next ten years, Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025.

The FDA organized the plan under goals for:

• Food safety
• Nutrition
• Animal health
• Organizational excellence

The FDA based the plan on basic principles:

1. Public health is the first priority
2. Partnerships are the key to success
3. Scientific expertise and research are the foundation
4. The program is committed to operating openly and transparently

Comments can be submitted on the strategic plan at any time.  Instructions for how to do so are here.

One possibility is to ask for further details.  The plan does not say how the FDA will accomplish the objectives, how much it will cost to achieve them, or whether it has adequate funding for everything it does (hint: it doesn’t).

Some of what it wants to do is puzzling.  For example, one Nutrition objective is this:

2.1: Provide and support accurate and useful nutrition information and education so consumers can choose healthier diets consistent with the Dietary Guidelines for Americans and other evidence-based recommendations.

I assume this refers to Nutrition Facts labels and menu labels, but one of its sub-objectives is:

Strategy 2.1d: Promote collaboration with stakeholders, including industry, consumer, and public health groups, to enhance consumer nutrition education directed towards age and demographic groups with specific needs.

I wish the report said more about this.  Surely the FDA is not suggesting that the food industry take responsibility for nutrition education?  I hope not.

The documents:

• Federal Register Notice
• FDA Home Page for the Plan
• The Strategic Plan for 2016-2015
• Blog: Charting a Path Forward on Food Safety, Nutrition and Animal Health

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.

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.