Currently browsing posts about: FDA

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.

It’s been 4 years since President Obama signed the Affordable Care Act authorizing menu labels to go national.

In 2011, the FDA proposed rules for public comment.  It proposed final rules in 2013:

• Rules for restaurant menu boards
• Rules for vending machines

But the FDA has never released the final rules.

How come?

The rumors I’m hearing say they are being held up by the White House Office of Management and Budget.

I first wrote about the delay in April 2013.

I complained about the delay again four months ago, when rumors suggested that it was due to pressures from owners of pizza chains and movie theaters.

I quoted Politico Pro Agriculture on the White House-induced delay:

It was three months ago today that the White House first received FDA’s final rules for calorie labels on menus and vending machines, and by the Office of Management and budget’s own rules, that means time is up. Interagency review at OMB is supposed to take no more than 90 days before the final release of a measure, though that timeframe is often extended with little explanation on more controversial initiatives. While OMB is always mum on its schedule for rule reviews and releases, the end of the standard review period is sometimes a hint that something will be coming, if not today — the day before a long weekend — then soon. In the meantime, brush up on the issue here: http://politico.pro/1mKNcFr and here: http://politico.pro/1lzZLDe.

Come on White House OMB: the election is over.  Let the FDA release the rules, please.

This is about public education, which is supposed to be bipartisan.

Remember menu labels?  We’ve had them in New York City since 2008.

In 2010, President signed national menu labeling into law as part of the Affordable Care Act.  The FDA proposed rules for labels in 2011, collected comments on the proposed rules, missed the July 3, 2014 deadline for issuing them, and by all reports sent them to the White House Office of Management and Budget last April.

• Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Proposed Rule
• Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Proposed Rule

What is the holdup?  Lobbying of course.

• The delay on releasing the final rules is widely reported to be due to lobbying efforts by industry groups.  Known to have visited the White House and FDA officials are, among others, the Food Marketing Institute, Publix Super Market, Schnuck Markets, Kroger, Dominos Pizza, the Pizza Hut Franchise Association and Hungry Howies.
• The Food Marketing Institute (FMI), the National Grocers Association (NGA) and Food Industry Association Executives (FIAE) held a lobbying “fly-in” to prevent FDA’s final menu labeling rule for calorie disclosures being extended to grocery stores.
• A bill backed by the supermarket industry is the Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) which would require menu labeling only for establishments where the majority of business is derived from restaurant-type food.

As for whether menu labels do any good:

• A CDC study reports that nearly all adults say they notice menu calorie labels, but only 57% say they use them.
• Research on the effectiveness of menu labeling has yielded mixed results and more research is needed, says a review published by the Robert Wood Johnson Foundation.
• One recent study says menu labeling has little influence on calories ordered regardless of how overweight people are.
• Menu labeling raises ethical issues related to population health and social equity, says another study.

At the moment, studies of the effects of menu labeling are restricted to laboratory models or situations in New York and other cities that passed such laws within the last few years.

More definitive research must wait for the final FDA rules and their application.

How about releasing the rules soon?  They’ve been dragging on way too long.

 

 

In June I wrote about the FDA’s advice to pregnant women to avoid eating fish high in methylmercury.  The advisory said to avoid the four fish highest in methylmercury:  shark, swordfish, king mackerel, and tilefish.

I was surprised that the advisory didn’t warn about the high mercury levels in albacore tuna, and I was skeptical about the FDA’s  insistence that pregnant women must eat fish.

Now Consumer Reports advises pregnant women not to eat tuna at all.

Consumer Reports:

• Asks  FDA Deputy Commissioner Mike Taylor to fix the charts it released with its advisory to make it clear that tuna is a high-mercury fish
• Issues copies of the charts showing amounts of methymercury in various kinds of fish.
• Publishes an article on the problems with mercury in fish.
• Gives the methods used as a basis for the article.

So what’s going on here?

In my book, What to Eat, I included a chapter on this very topic: “The Methylmercury Dilemma.”  Here’s a quote:

Albacore tuna clearly belonged on the list of fish to avoid, but advice to restrict its consumption would surely affect the livelihoods of people who fish for, can, and sell tuna.   Because hardly anyone knows the difference between one kind of tuna and another, fish companies worried that consumers would interpret advice to avoid albacore tuna as advice to avoid all tuna.  Industry lobbyists urged the FDA to keep albacore tuna off the methylmercury advisory.   Somehow, albacore tuna got left off.

That was in 2006.   Consumer Reports tells us that pretty much all tuna is too high in methylmercury to be consumed by pregnant women.  So this comment still seems relevant, no?

Evidence: Here’s the response from the National Fisheries Institute:  “Consumer Reports has long history of intentionally mischaracterizing tuna.”

Food Navigator—USA’s Elaine Watson just put together a special edition on the revamping of the Nutrition Facts label.  Her title: Radical overhaul or a missed opportunity?

To understand what’s happening with food labels, you can start with the FDA’s home page on its proposed revisions.  The comment period has ended.  You can read the comments that have been filed on the Nutrition and Supplement Facts panels, and those filed on the proposed changes to the standards for serving sizes.  These are fun to read; opinions, to say the least, vary.

But back to Food Navigator, which collects in various pieces on the topic in one place.  The “Radical overhaul” piece contains a summary of the major provisions.  Others in the series are also useful (I’m quoted in some of them):

Does vitamin D belong on the Nutrition Facts panel?

FDA proposals to list “added sugars” on the Nutrition Facts panel have already generated heated debate, so it’s perhaps unsurprising that its plan to include vitamin D is proving equally controversial…

Should ‘added sugars’ be listed on the Nutrition Facts panel?

A row is brewing over the merits of including ‘added sugars’ on the Nutrition Facts panel, with critics arguing that our bodies don’t distinguish between ‘naturally occurring’ and ‘added’ sugar – and neither should food labels – and supporters saying it will help consumers identify foods with more empty calories.

 Nutrition Facts overhaul is a missed opportunity for long chain omega-3s EPA and DHA, says GOED

The FDA’s overhaul of the Nutrition Facts panel misses a public health opportunity by prohibiting firms from even highlighting long chain omega-3 fatty acids EPA and DHA on the panel, says GOED.

What are the biggest contributors of added sugars to the US diet?

Check out this analysis of NHANES data to see where our added sugars are coming from plus read new comments about the ‘added sugars’ labeling proposal from Ocean Spray cranberries and others.

Former FDA commissioner: Nutrition Facts overhaul doesn’t go far enough

FDA proposals to overhaul the Nutrition Facts panel on food labels don’t got far enough, says former FDA commissioner David Kessler, M.D.

Behavioral scientists: Changing serving sizes on Nutrition Facts label could have unintended consequences

FDA proposals to change the way serving sizes are calculated to better reflect real-life eating behavior could encourage some people to eat even more unless the wording is changed, says one expert group.

Until phosphorus gets on the USDA’s radar, labeling policy won’t change: NKF

While phosphorus is an essential nutrient found naturally in some foods such as egg yolk and milk, it is increasingly added to packaged foods via a raft of phosphorus additives, and some experts believe it should be listed on the Nutrition Facts panel.

Canada’s proposed Nutrition Label changes emphasize calories, sugar

Health Canada is proposing changes to nutrition labels that would make them easier for consumers to read.

RD: There’s a health continuum for every food; what pillars do you want to stand on?

Rachel Cheatham, RD, founder of nutrition strategy consultancy FoodScape Group, talks food labeling at the IFT show.

Is your product ready for nutrition label changes?

“A 16-ounce drink and a two-ounce bag of potato chips are a single serving. If it’s bigger than that, from 200 to 400%, then you need to declare two columns of information—one for the serving size and one for the whole container.”

Proposed nutrition labels more effective than current labels: survey

Consumers find proposed labels easier to read in less time.

How much do consumers use (and understand) nutrition labels?

New research from the NPD Group is questioning how many US consumers even routinely check nutrition labels anymore.

 FDA’s proposed nutrition label changes emphasize calories, serving sizes

If approved, the new labels would place a bigger emphasis on total calories and update serving sizes, while also drawing attention to added sugars and nutrients such as Vitamin D and potassium.

CRN, NPA submit comments on FDA’s proposed changes to food, supplement labels

Both the Council for Responsible Nutrition and the Natural Products Association have submitted a comments on FDA’s proposed revisions for food and dietary supplement labels.

The FDA’s next step is to deal with the comments and issue final rules.  By when?

Eventually.  Stay tuned.

The FDA is taking comments on its proposals to revamp the food label through August 1, 2014 (instructions are at bottom of post).

I’ve already filed comments on Added Sugars and on whether Vitamin D should be added to food labels.

And I just filed further comments on the FDA’s proposals for the Nutrition and Supplement Facts Labels.  If you would like to read what I said, click here.

I’ve also filed comments on the FDA’s Serving Size proposals.

These proposals are highly technical and tough to slog through, so I tried to deal with the big picture.

July 27, 2014

TO:                  FDA

FROM:           Marion Nestle, Professor of Nutrition, Food Studies and Public Health, New York University

RE:                  Comments: Serving size proposals, Docket No. FDA-2004-N-0258

In addressing the question of how to change serving size designations on food labels, FDA is faced with an impossible dilemma .  Serving sizes, which are supposed to be based on amounts typically consumed from packaged products, are invariably perceived as recommendations for dietary intake.

To comment on each of the bold-face, italicized points:

• Typically consumed:  This information derives from dietary intake surveys which invariably underestimate actual intake, often by 30% to 40%.

• Packaged foods: Food labels only appear on packaged foods.  RACC amounts on packaged foods are often much lower than amounts served in restaurants or fast-food places (pizza is an obvious example).  It is unclear whether amounts reported as consumed are from packages (with Nutrition Facts labels) or are from restaurants or fast-food places where portion sizes can be much higher than those for foods in packages.

• Recommendation:  Substantial anecdotal information suggests that people view labeled serving sizes as what they should be eating.  They view the serving sizes as meaningless compared to the portion sizes of foods they are accustomed to eating.

What is well established is that overall calorie intake has increased since RACCs were established in 1993 and marketplace portion sizes have also increased.

Therefore, any increase in RACC runs the risk of being interpreted as a validation of current portion sizes and as a recommendation to eat more.

On the other hand, larger portions have more calories.  These must appear on the label.

To address this dilemma, FDA should:

• Make dual-column labeling mandatory for all food and beverage packages likely to be consumed in one sitting.
• Require total calories in the package to be displayed on the front of the package.
• Include a footnote explaining that the serving size is not meant as a recommendation

INSTRUCTIONS FOR FILING COMMENTS

The FDA provides:

• All necessary information in one place.
• A short guide and checklist

File comments here

• Nutrition and Supplement Facts Label: Docket FDA-2012-N-1210  Comment here now
• Serving Sizes: Docket FDA-2004-N-0258  Comment here now