Currently browsing posts about: FDA

Let’s start with the report issued by the Department of Health and Human Services’ Office of the Inspector General (OIG).  Now that the Food Safety Modernization Act gave the FDA the authority to issue recalls of unsafe food, the OIG wanted to know how it was using that authority.  OIG’s opinion:

FDA did not always have an efficient and effective food-recall process that ensured the safety of the Nation’s food supply. We identified deficiencies in FDA’s oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES). Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always

(1) evaluate health hazards in a timely manner,

(2) issue audit check assignments at the appropriate level, (

3) complete audit checks in accordance with its procedures,

(4) collect timely and complete status reports from firms that have issued recalls,

(5) track key recall data in the RES, and (6) maintain accurate recall data in the RES.

FDA Commissioner Scott Gottlieb responded to the OIG report.

The FDA has authority to act in a variety of ways when it is made aware of an unsafe food product. But often the fastest and most efficient way to ensure unsafe foods are recalled quickly is by working directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on….Fortunately, most companies are cooperative and rapidly initiate a voluntary recall of a hazardous food product. On average, the recall occurs within four calendar days of the problem being discovered…Sometimes the recall process does not work as well as we’d like.’

In that response, he explains that the FDA has more work to do.   He also says so on Twitter.

Politico’s Dan Diamond interviewed Gottlieb last week. As Politico Morning Agriculture puts it, “Pour coffee & listen here” to the interview.

In the meantime, CSPI and other food-safety advocacy groups are asking the FDA to reveal the names of retailers that are selling recalled products.  What they—and food safety lawyer Bill Marler—are also arguing is that the FDA needs to release the names of retailers who are selling recalled goods as a measure to help consumers protect themselves.  The FDA appears to consider this information proprietary.  If so, it is putting business profits above public health and should rethink that policy.

As the Washington Post puts it, the FDA’s interpretation

differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption.

Documents 

• The OIG’s preliminary findings in 2016
• The OIG report summary 
• The full OIG report
• USA Today’s account
• The New York Times’ account

The FDA announced last week that it is terminating its Food Advisory Committee (see the Federal Register notice) 

The U.S. Food and Drug Administration today announced it will not renew the charter of the Food Advisory Committee. FDA instead will address relevant issues using other standing committees and consulting with individual additional experts in appropriate subjects as needed. In addition, the agency will continue its robust stakeholder engagement program and to solicit broad public and expert input on its policy documents and regulations.

The FDA’s Food Advisory Committee has held only a handful of meetings over the past several years and has not met since 2015. Therefore, FDA has determined that the effort and expense of maintaining the advisory committee is no longer justified…The Food Advisory Committee was established on March 6, 1992. The termination of the Food Advisory Committee is effective December 12, 2017.

I was a member of the first Food Advisory Committee from 1992-1994—as one of four consumer representatives on a committee of about 30.  We were there during the time the FDA was approving genetically modified bovine somatotropin and the Flavr Savr tomato.  The four of us did all we could to get the FDA to label GMOs, but no luck.

My abiding memory of this committee was our debriefing when we rotated off it.  By that time, we were puzzled as to the committee’s purpose (since the FDA never seemed to pay much attention to our recommendations).

The answer: the purpose of the committee was to give the FDA early insight into how its decisions—decisions it had already made—would be perceived.

Oh.

Nevertheless, I co-signed a letter to the FDA calling for retention of the committee and for making it more useful.

CFSAN [FDA] has indicated that it will continue to hold workshops, meetings, conferences, and webinars to engage with its stakeholders. While we appreciate the outreach FDA does, only an advisory committee meeting can provide helpful recommendations to the agency that are the result of interactive discussion among stakeholders. Moreover, industry and academic experts may speak with an independent voice when they are members of advisory committee meetings, while in public meetings, they may be representing the view of companies that employ or fund them.  Most importantly, many of the alternative forms of outreach identified by the FDA will not be subject to the transparency and conflict-of-interest requirements associated with advisory committees.

This committee could help the FDA with the many challenges it faces carrying out its food and nutrition mandates.  But this looks like another FDA decision already made.

I know that everyone loves chocolate, but to snort???

The FDA, ever on the job, has issued a warning letter to Arco Globus Trading that its snortable Coco Loko product–cocoa powder infused with caffeine, gingko, taurine, and guarana–is being marketed illegally as an unapproved street drug.

the claims made in your promotional materials for Legal Lean Syrup and Coco Loko demonstrate that these products are intended to be used as alternatives to illicit street drugs…With respect to Coco Loko, a powder substance, you describe it in your labeling as a “snuff” and you promote it to be “snorted” (inhaled intranasally).  Intranasal administration of a powder substance can trigger laryngospasm or bronchospasm and induce or exacerbate an episode of asthma.  Furthermore, the ingredients listed on the product label for Coco Loko include taurine and guarana.  The safety of these ingredients for intranasal administration has not been evaluated.

I can’t find an official website for the product (it seems to have disappeared) but the FDA says that Coco Loko does not qualify as a supplement (it is snorted, not eaten, and it actually intended for use as a street drug:

• “Endorphin rush . . . it triggers a positive feeling of well being in your body similar to morphine.”
• “Serotonin rush . . . will produce an elevated mood and a state of euphoria similar to the feeling of ecstasy.”
• “Euphoric energy . . . Raw cacao will give you a steady rush of euphoric energy . . ..”
• “Raw cacao . . . is also known to help with anxiety and to reduce stress.”
• Coco Loko Review by I Suck At Talking (Youtube video on your website): “Raw cacao is linked to numerous health benefits . . . lower blood pressure and improved blood circulation . . ..” (1:04 – 1:13)

Snorting cocoa powder?  Really?  Not a good idea (even though no calories that way).

You can’t make this stuff up either.

The FDA is taking comments about developing a list of dietary supplement ingredients in safe use before Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994.

It announced a public meeting for October 3 ton this issue.

The FDA also announced that it is accepting public comments on its draft guidance. on New Dietary Ingredients (NDIs).

Here are the FDA documents:

• Federal Register Notice Announcing the Public Meeting
• Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry
• Federal Register Notice for the Draft Guidance
• Background and Information about Submitting NDI Notifications
• Public Meeting page

What this is about

A timeline may help:

• 1994: Congress passed the Dietary Supplement Health and Education Act which essentially deregulated dietary supplements.
• It did, however, require marketers of “New Dietary Ingredients (NDIs)” to submit a premarket notification to the FDA at least 75 days before introducing it—unless the ingredient had a history of safe use before that date.
• 1997: FDA issues regulations for NDIs
• 2011 (January): The Food Safety Modernization Act passes.  This required the FDA to clarify when an ingredient is considered NDI.
• 2011 (July):  FDA publishes draft guidance
• 2017 (September):  FDA issues draft guidance for comment

As the FDA explains, one purpose of this guidance is to improve compliance with the NDI notification requirement.

In 2012, FDA estimated that the number of dietary supplements on the market was 55,600 and that 5,560 new dietary supplement products come on the market each year. This is in contrast to the approximately 4,000 products that were on the market in 1994, when DSHEA was enacted.

As of December 2014, we had received and completed our evaluation of just over 750 NDI notifications since the first notification was received in 1995.

These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles

The FDA also explains:

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

How are we to interpret this?  

My take is that DSHEA is a public health disaster.  It allows supplement companies to use pretty much whatever ingredients they want and to continue doing so until there is substantial evidence for harm.

This must be an attempt by the FDA to exercise some kind of control over ingredients in supplements.  As such, the measure deserves support.

File comments by December 4; go to http://www.regulations.gov and type FDA-2017-N-4625 in the search box.

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.”