Currently browsing posts about: FDA

On my 12th-floor Manhattan terrace, I grow cilantro every summer.  I like to have it handy.  And I know it’s local, organic, seasonal, and deer-free—and unlikely to be contaminated with Cyclospora.

The CDC reports 358 people to be ill with Cyclospora, most likely because they ate cilantro imported from Mexico.

It doesn’t take much web surfing to find out anything you want to know about such problems.  I like to use three sources:

The CDC

• Information about Cyclospora
• A paper on Outbreaks of Cyclosporiasis — United States, June–August 2013
• A fact sheet
• An explanation of investigations of foodborne outbreaks
• 2014 Outbreak Investigations
• 2013 Outbreak Investigations
• Advanced Molecular Detection for Cyclospora
• Time to Think About Cyclosporiasis
• A Webinar for health-care providers

The FDA

• A statement
• Advice for consumers.
• An import Alert
• An explanation of how the US is working with Mexico to make cilantro safer
  

Bill Marler

• His blog

Yesterday, the FDA announced a delay in implementation of menu labeling until December 1, 2016.

Since the FDA issued the menu labeling final rule on December 1, 2014, the agency has had extensive dialogue with chain restaurants, covered grocery stores and other covered businesses, and answered numerous questions on how the rule can be implemented in specific situations. Industry, trade and other associations, including the grocery industry, have asked for an additional year to comply with the menu labeling final rule, beyond the original December 2015 compliance date. The FDA agrees additional time is necessary for the agency to provide further clarifying guidance to help facilitate efficient compliance across all covered businesses and for covered establishments to come into compliance with the final rule. The FDA is extending the compliance date for the menu labeling rule to December 1, 2016, for those covered by the rule.

Here are the relevant Federal Register notices:

• Federal Register Notice for the Compliance Date Extension
• Menu and Vending Machines Labeling Requirements

Let’s be clear about what’s going on here.  New York City, where I live, has had menu labeling since 2008.  The world has not come to an end.

The Affordable Care Act made menu labeling go national in 2010.  The Supreme Court affirmed that law in 2012.

The seemingly endless delays look like successful lobbying at the expense of consumers and public health.

The New York Times account quotes me on this point:

This is a huge victory for the restaurant lobbyists,” said Marion Nestle, a professor in the department of nutrition, food studies and public health at New York University. “Food companies must be hoping that if they can delay menu labeling long enough, it will just go away.

The pizza industry, one of the chief lobbying groups on this issue, is pleased by the decision.  Lynn Liddle, Chair of the American Pizza Community sent out this statement yesterday:

FDA’s delay confirms both the serious deficiencies in the final rules and the urgent need for enactment of the bipartisan Common Sense Nutrition Disclosure Act (H.R. 2017).  Unfortunately, FDA proceeded with an approach to final rules that impose significant compliance costs without achieving any meaningful improvements in consumer education.  After years of uncertainty, FDA still has not addressed basic questions regarding implementation.  The American Pizza Community looks forward to continuing to work with Members of Congress to secure timely passage of the Common Sense Nutrition Disclosure Act.

If you can’t get federal agencies to back off on public health, go right to Congress.

The pizza industry had already succeeded in getting this provision in the House Agricultural Appropriations bill:

SEC. 744. None of the funds made available by this Act may be used to implement, administer, or enforce the final rule entitled ‘‘Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments’’ published by the Food and Drug Administration in the Federal Register on December 1, 24 2014 (79 Fed. Reg. 71156 et seq.) until the later of— (1) December 1, 2016; or (2) the date that is one year after the date on which the Secretary of Health and Human Services publishes Level 1 guidance with respect to nutrition labeling of standard menu items in restaurants and similar retail food establishments.

Although this act is not yet passed and it’s not clear whether this provision would have survived, the FDA got the message (or maybe the White House made sure that it did?).

Menu labels inform the public about the number of calories in the foods they are buying.

The ferocity of lobbying on this idea suggests that restaurant companies would rather you did not have this information.

The FDA, alas, is not helping much on this one.

I’m still catching up on what happened during the week I was offline in Cuba (more on that later this week).

One big event was the FDA’s announcement that it no longer considers artificial trans fat as generally recognized as safe (GRAS) for human consumption, meaning that processed food manufacturers need to get rid of it.  They get three years to do so.

Here are the relevant documents:

• Federal Register Notice: Final Determination Regarding Partially Hydrogenated Oils June 2015
• Federal Register Notice: Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information; Extension of Comment Period December 2013
• Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)
• FDA Blog: Protecting Consumers from Trans Fat
• Press Release: The FDA takes step to remove artificial trans fats in processed foods

Center for Science in the Public Interest, which has petitioned the FDA to get rid of trans fats for decades, describes this move as a “huge advance.”

As for complications:

• The Environmental Working Group (EWG) is worried about the half-gram loophole:  “FDA memos show…80 percent of these uses [of partially hydrogenated oils containing trans fat] don’t require disclosure of the presence of trans fat because of the half-gram loophole.”
• Politico Pro reports that “food industry lawyers are already scouring the document in hopes of finding some way to shield them from legal action” and that a ban on trans fat will increase demand for palm oil causing widespread deforestation across Indonesia and Malaysia.
• Politico Pro also reports on a lawsuit filed immediately against Heinz for using trans fat in its frozen microwave french fries and tater tots while marketing its products as trans fat free.

I vote for the FDA’s move as a long-awaited step in the right direction.  Progress!

Addition, July 5:  The Wall Street Journal’s editorial board has a somewhat different view.  Trans fats are already gone, thanks to consumers, and all the FDA has done is to set up a basis for class-action suits.

I was interested to read Michael Taylor’s comments on the recall of Blue Bell ice cream contaminated with Listeria.  Mr. Taylor is Deputy FDA Commissioner for food safety.

This was an outbreak in which 10 people were hospitalized and three died.  The best place to begin on this is on the CDC website for the Blue Bell outbreak.  It provides excellent graphics summarizing the number of cases and where they occurred:

This outbreak was particularly awful because inspections had found severe violations of standard food safety procedures, yet the company ignored them.  The result: people died.

Mr. Taylor asks if this outbreak could have been prevented with better FDA regulation.  In 2010, Congress passed the FDA Food Safety Modernization Act (FSMA) but it’s taken time for the implementation.  Taylor says:

the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections.Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.

But, he says, to implement the law, the FDA needs funding: “If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.”

Congress, no doubt, will continue to keep the FDA on a short string.  No industry likes being regulated and the food industry fights regulation in every way it can.

The FDA needs to do more to ensure food safety but can’t without inspectors.

That leaves legal approaches.  For these, I go right to the websites of the Marler-Clark law firm, which specializes in food safety cases.

Here’s what Bill Marler and his colleagues have had to say about the Blue Bell case (most recent first and I may be missing some):

• June 6  Listeria found in Blue Bell ice cream from Alabama plant
• June 2: Blue Bell Agrees to Do What It Should Have Been Doing All Along
• May 31: A Blue Bell Listeria Timeline – 2010 to 2015
• May 22: So, Why Did Blue Bell Ignore FDA’s: “Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods?”
• May 21: Blue Bell Missed Warning Signs to Avoid Listeria Contamination, Illnesses, Recalls, Layoffs and ?
• May 16: Bad Listeria Management Causes 2850 Blue Bell Employees Out of Work
• May 15: Kruse: “An Agonizing Decision” – But It Was Preventable
• May 15: Blue Bell Knowingly Sold Ice Cream From A Plant With Listeria
• May 14: Blue Bell Enters Consent Decree with Texas and Oklahoma (Likely Alabama Too) To Do What It Always Should Have Been Doing – Make Safe Food
• May 14: Blue Bell Ice Cream For Sale: Stupid Is As Stupid Does
• May 7: Paul Kruse, President and CEO of Blue Bell Ice Cream – My Advice, Get a Good Criminal Lawyer
• May 7: Blue Bell Ice Cream Manufacturing – An Accident Waiting to Happen
• April 20: Listeria outbreak kills three in Kansas linked to ice cream consumed from Blue Bell Creameries
• April 8 (?): Blue Bell Ice Cream Listeria Outbreak
• March 15: Marler – The Food Safety Lawyer – Update On Blue Bell Ice Cream Listeria Outbreak
• March 13: Blue Bell Creameries Listeria Outbreak Sickens 5 in Kansas Killing 3

Marler-Clark is filling a critical regulatory gap by suing companies that cause foodborne illnesses and deaths.  But this is after-the-fact.

As Bill Marler has been pleading since 2007: please put me out of business.

Prevention would be much, much better.  Hence the need for more FDA resources.

Update, June 12: The CDC concludes its investigations and the FDA releases reports

Here are two more items on the endless disputes over sugar intake.

1.  The IOM’s 25% of calories from sugar “recommendation”

I was surprised to see the Institute of Medicine’s upper limit of sugar safety cited in a JAMA commentary on sugars and heart disease. The authors disagreed with the conclusions of a study by Yang et al. in JAMA Internal Medicine:

Most US adults consume more added sugar than is recommended for a healthy diet. We observed a significant relationship between added sugar consumption and increased risk for CVD mortality.

The authors of the commentary say:

The relationship between added sugar intake and CVD mortality remains unresolved. The study by Yang et al¹ does not support implementation of health policies limiting sugar intake because a relatively small fraction of the total population ingests excessive amounts of sugar by the IOM criteria….Laws attempting to limit excess sugar intake have been passed and overturned on legal grounds. Aside from the legal questions, there is insufficient scientific evidence to support pursuit of policies limiting sugar intake.

They then go on to say:

The Institute of Medicine (IOM) recommendation is that less than 25% of total kilocalories come from added sugar.

Oops.  The IOM made no such recommendation.

Instead, the IOM said 25% of calories was the upper limit of safe sugar intake for nutrient deficiencies.  The risk of nutrient deficiencies increases above that percentage.  That IOM report said nothing about the relationship of sugar quantity to risk of chronic diseases.

Most health authorities recommend no more than 10% of calories from added sugars as a means to reduce the risk of obesity, diabetes, and heart disease.

Most research shows that chronic disease risks increase with increasing sugar intake.

 2.  What is the FDA doing about “Added Sugars” on food labels?

According to all sources, the FDA is still working on what to do about Added Sugars on the new Nutrition Facts panel.  It is engaged in two studies of this question.

It says the added sugars study is complete and the data are being analyzed.  It says the format study is in the works.

The FDA was criticized for proposing added sugars on the label without having done the research first.  Apparently, the White House Office of Management and Budget took 9 months to approve the FDA’s proposal to do the sugar research.  The approval came after the FDA issued its label proposal.

The bottom line on sugar: Less is better.

Today’s New York Times has a front-page story about how the FDA knew that certain weight-loss supplements contained unlabeled amphetamine-like substances but did nothing about it, perhaps because its head supplement official came from the industry (and has since returned to it).

Let’s start with the science.

In 2014, Pieter Cohen and his colleagues noted that several athletes had been disqualified from competition after tests found evidence of a methamphetamine analog (N,α-diethyl-phenylethylamine) in their urine.  The athletes said that the chemical must have come from their workout supplements.  Cohen et al. tested the supplements and identified the analog as one with entirely untested stimulant, addictive, or other adverse effects in humans.  They recommended its immediate removal from all dietary supplements.

Earlier that year, the FDA reported that 9 of 21 supplements containing Acacia rigidula to test positive for varying amounts of another methamphetamine analog, β-Methylphenethylamine (BMPEA).   The FDA investigators said this compound could be misidentified as amphetamine during certain kinds of analyses, but did not identify the products found to contain BMPEA.

Cohen et al. then did their own tests of the kinds of supplements the FDA had tested.  

The stimulant was present at quantities such that consumers following recommended maximum daily servings could consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements.

The New York Times explains the context:

The controversy comes at a time when the supplement industry is under increased scrutiny. Last week, 14 state attorneys general, led by Eric T. Schneiderman of New York, called on Congress to provide the F.D.A. with more power to regulate supplements. Mr. Schneiderman’s office in February accused four major retailers of selling contaminated herbal supplements, and one of the companies, GNC, has agreed to extensive new testing and quality control procedures for its store-brand herbal products.

This brings us to the politics.

The supplement industry, of course, is doing everything it can to oppose and stop Schneiderman’s work.

Recall that Congress passed the Dietary Supplement Health and Education Act in 1994, essentially deregulating the industry.  The act allowed absurd health claims for supplements and essentially removed much of the FDA’s authority to regulate these products.

The result was an increase in sales despite remarkably little evidence for efficacy.

As for conflicts of interest at FDA:

• Daniel Fabricant, the head of the FDA’s dietary supplement division at the time this was happening, came to the agency from the Natural Products Association, “Over 75 years of serving the natural products industry.” He has since left the FDA and now heads the NPA.
• The NPA spent nearly $1.5 million on lobbying in 2013 and 2014.
• The current head of the FDA’s dietary supplement division, Cara Welch, also came to FDA from the NPA.

Since DSHEA, the dietary supplement industry has gotten a pass.  Suggestions:

• Congress should rescind DSHEA and give the FDA the authority to regulate supplements as it does food.
• The FDA should appoint officials who are independent of the industries they are supposed to regulate.

The Government Accountability Office has just released a new report.

Much of the report is about the need for better coordination of the food safety oversight responsibilities of the USDA (meat and poultry) and those of the FDA (everything else), not to mention the 13 other agencies that deal with aspects of food safety (the report provides a handy summary chart).

This report points out that both agencies

have mechanisms in place to facilitate interagency coordination on food safety that focus on specific issues, but none provides for broad-based, centralized collaboration…[Existing]mechanisms do not allow FDA, FSIS [USDA], and other agencies to look across their individual programs and determine how they all contribute to federal food safety goals. Nearly all the experts GAO interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The Food Safety Working Group (FSWG) served
as a centralized mechanism for broad-based food safety collaboration and resulted in a number of accomplishments, including improved coordination. However, the FSWG is no longer meeting…Without a centralized collaborative mechanism on food safety, there is no forum for agencies to reach agreement on a set of broad-based food safety goals and objectives.

The GAO complains that “for more than a decade, we have reported on the fragmented nature of federal food safety oversight.”

Actually, its complaints go back longer than that but here’s one from 1999:

I will have to go through my files but as I recall, the GAO started arguing for a single food safety agency sometime in the early 1990s.  Political realities make that idea impossible.  Instead, we have the Food Safety Working Group which seems to have stopped meeting.

It’s good the GAO is still on the case.  We need better food safety oversight.

Tomorrow’s example: Caramel apples.

This morning’s Politico Pro Morning Agriculture says that FDA menu labeling (see Monday’s Post) is not the only food rule being held up by the White House.

The issue: The White House is supposed to sign off or reply within 90 days, or formally request an extension.  That’s not happening with menu calorie labeling or four others:

• The Common or Usual Name for Raw Meat and Poultry rule: this refers to what you can call meat and poultry with added water, salt or other ingredients.  The White House has been sitting on rule for review since April 30.   Chicken producers love it.  Some meat producers don’t.  Here’s the initial proposal.  It’s not clear whether or how it’s been altered.
• Child Nutrition Program Integrity and Child and Adult Care Food Program proposals: these rules, also sent in April, deal with USDA’s implementation of the Healthy Hunger Free Kids Act. The integrity rule deals with mismanagement.  The other one requires USDA to update the meals to comply with dietary guidelines every 10 years.
•  USDA’s catfish inspection rule: Sent to the White House on May 30, this would implement a section of the 2014 farm bill that puts USDA, not FDA, in charge of catfish inspections (see previous post on this).
• EPA’s Renewable Fuel Standard for 2014: This was sent August 22.  The White House has not extended the review period.  f the administration does take more time to officially complete its review, it could push the release of the rule governing how much ethanol needs to be mixed into gasoline for 2014 into 2015.

What’s going on?  Politics, of course.  But I can only speculate on what they might be.