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Thanks to Elaine Watson at FoodNavigator-USA for writing about Coca-Cola’s efforts to get the FDA to let it put vitamins in its drinks.  OK, its “healthier” drinks.

Historically, the FDA discouraged (putting it mildly) makers of candy and other junk foods from adding vitamins so they could be marketed as “healthy.”  This was known as the “jelly bean rule.”   Vitamins could not be added to jelly beans—or Coca-Cola.

It’s not really a formal rule, but here’s what the FDA says in 21CFR104.20:  ​​

The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.

But what about the exceptions?

• Gummy Bears: vitamins are be added to gummy bears, but these are typically sold as dietary supplements, not foods. They can do this because the Dietary Supplement Health and Education Act of 1994 authorized much looser rules for supplements.  Even though gummy bears are candy, the FDA isn’t going to fight this one.
• Glaceau Vitamin Water:  Coca-Cola now owns this company. Some Vitamin Waters have as much sugar as a Coke.  They have Nutrition Facts labels and are marketed as foods, and look to me to be in violation of the jelly bean rule,.  The FDA hasn’t done anything about them, even though they are vitamin-enriched sugar water.  If you have any idea why not, please tell me.

For decades, Coca-Cola has tried to get the FDA to ease up on the jelly bean rule.  Now it is trying again.

Its argument?  The rule, by not allowing the addition of vitamins to sugary teas and coffees, stifles innovation.

Its assurance?  It won’t add vitamins to Coke, but will add them to its other, presumably “healthier” (meaning, I suppose, less sugary) beverages.

As I wrote earlier, candy makers are trying this trick too.

I wonder how long the FDA can hold out on this one.  I wish it luck.

I don’t know whether to laugh or cry when I hear things like this.  According to a report from the Associated Press, the FDA plans to follow the Trump administration’s deregulaory agenda by getting rid of the standard of identity rules for frozen cherry pies.

The rules currently require commercial frozen cherry pies to be filled with “mature, pitted, stemmed cherries that are fresh, frozen, and/or canned,” to contain at least 25% cherries by weight, and to have no more than 15% of the cherries with blemishes.

In October, then-FDA Commissioner Scott Gottlieb sent out this tweet.

In a June email, the FDA said it planned to revoke the standard for frozen cherry pies in April. It has kept its word.

My questions:

• Without the standard of identity, are we likely to have more or fewer cherries in frozen cherry pie?  [Want to make a bet?  I’m guessing fewer].
• What lobbying group got the FDA to do this, and why did the FDA agree?
• Did ex-Commissioner Gottlieb really consider this a top priority for FDA? [If so, we are in even worse trouble than even I imagined].

I’m stuck on regulatory priority.  Food safety, anyone?

As for the origins of the cherry pie count, see this excellent piece in the Washington Post by historian Xaq Frohlich.

Last week, the USDA and FDA ended their turf battle and announced a joint framework for jointly regulating cell-based meat products.

Congress instructed them to do this in a statement related to the Appropriations Act:

Not later than 60 days after the date of the enactment of this Act, the Secretary of Agriculture and the Commissioner of Food and Drugs shall enter into a formal agreement delineating the responsibilities of the two agencies for the regulation of cell-cultured food products derived from livestock and poultry. Such agreement shall be made public on the USDA and FDA websites within one day of the completion of the agreement.

These products, not yet on the market, are made from animal cells grown in tissue culture; no animals are killed in the process.

What to call these emerging products is a matter of some debate.  Proponents call them such things as in vitro, lab-based, vat-grown, or clean.

The meat industry wants them called artificial, synthetic, or fake.  It publishes a flier called “Fake Meat Facts.”

The proposed plan calls for the FDA to regulate the collection of animal cells, cell banks, and cell growth—the processes.  USDA will oversee production, as it does for live animals and poultry.

Much must be at stake.  The agencies’ framework is proactive; the products are not expected to be marketed for several years.

The meat industry is relieved that USDA is in charge.

National Cattlemen’s Beef Association President Jennifer Houston said, “The formal agreement announced today solidifies USDA’s lead oversight role in the production and labeling of lab-grown fake meat products.”

“This is what NCBA has been asking for, and it is what consumers deserve,” Houston said.

The market for these products is expected to be huge, but questions remain:

• Lab-based: Is it really environmentally friendly?
• And yes, more research is needed.

We will be hearing a lot more about these products as they head to market.

The FDA held a public meeting last week on lab-grown “meat,” meaning, in FDA-speak, “foods produced using animal cell culture technology.”  The meeting agenda is here.

At issue are:

• Basic questions about transparency, marketing, environmental sustainability (see report by Friends of the Earth).
• The safety of these products (Consumer Reports has questions about the safety of these products).
• Can these products be called meat?  (The Atlantic calls this issue “farcical”).
• Which agency, FDA or USDA, should regulate them and decide such questions?

The FDA’s announcement of the meeting, and FDA Commissioner Scott Gottlieb’s statement staked FDA’s territory over these products.  Gottlieb said:

The FDA has a long history of ensuring food safety and applying our statutory framework while supporting rapidly evolving areas of technological innovation in food. The agency currently evaluates microbial, algal and fungal cells generated by large-scale culture and used as direct food ingredients. The agency administers safety assessment programs for a broad array of food ingredients, including foods derived from genetically engineered plants, and also manages safety issues associated with cell culture technology in therapeutic settings.

But if these foods are meat, then USDA is responsible for their regulation.  In a statement to Politico (behind paywall), a USDA spokesperson said:

According to federal law, meat and poultry inspections are the sole purview of USDA, so we expect any product marketed as ‘meat’ to be USDA’s responsibility. We look forward to working with FDA as we engage the public on this issue.”

Politico points out what’s at stake in the jurisdictional dispute.

There are at least 10 lab-grown meat companies across the globe that are furiously working to figure out how to get their products to market. Some of the startups are driven by a desire to reduce animal agriculture’s environmental footprint as developing countries increasingly drive demand for meat and dairy products. Major investors who’ve moved to get into the action include innovators like Bill Gates, Richard Branson, and Tyson Ventures, an investment arm of meat giant Tyson Foods.

The meat industry, as you might expect, does not want these foods to be called “meat.”  But the industry has not reached agreement on strategies (some meat companies have invested in lab-grown meat startups).

The US Cattlemen’s Association (USCA) in February asked federal government regulators to adopt a definition for meat that would exclude cell-cultured products (often called “clean meat“).  This week though, the more-powerful National Cattlemen’s Beef Association (NCBA) asked the same regulatory agency to rule the opposite.

The NCBA wrote  a letter to USDA stating its position:

NCBA is alarmed by the growing number of flagrantly deceptive food product labels proliferating the marketplace. Consumers have the right to expect that the information on food labels is truthful and not misleading, just as all food products should expect to compete on a fair, level playing field…NCBA firmly believes that the term beef should only be applicable to products derived from actual livestock raised by farmers and ranchers.

Global Meat News has a good summary of the industry’s concerns.

Four members of Congress chided the FDA for jumping into this:

Cell-based food technologies and products are an emerging science, and both agencies should be working collaboratively on a scientific approach towards a framework to regulate these products.

Good luck with that.  The Food and Environment Reporting Network (FERN) has a report on the FDA meeting.  I’m quoted:

Between the two agencies, I favor FDA…USDA’s primary role is to support and defend industrial agricultural production. The agency tolerates, but is unenthusiastic about organics. It will do the same for lab-based meat.

The FDA has opened questions about lab-grown meat for public comment.  File comments here.  The deadline is September 25.

Added comment

At a Politico Summit meeting today,

FDA Commissioner Scott Gottlieb said…that the agency is working closely with USDA on early efforts to establish a regulatory framework for lab-grown meat, or “cell-cultured foods,” the FDA’s preferred name for it.

We shall see.

The Trump Administration announced its new plan to reorganize government.  Obviously, this affects the agencies dealing with agriculture, food, and nutrition issues—USDA, FDA, and FDA’s parent agency, HHS.  Here is my translation of the major shifts being proposed:

• Move most of USDA’s nutrition programs—SNAP, WIC, the Child and Adult Care Food Program, and the Farmers’ Market Nutrition Program—to HHS.
• Move FDA’s food safety oversight to USDA, putting USDA in charge of all food safety.
• Downsize the Public Health Service Commissioned Corps.

Congress would have to vote on all this so there’s no point in going too deeply into the weeds at this point, but I have just a few comments:

• Putting all food safety oversight in one agency is a good idea, but not if it’s USDA.  USDA’s principal purpose to to support agribusiness.  Holding agribusiness responsible for food safety puts USDA in conflict of interest.
• Moving SNAP and WIC into HHS (or whatever its new name will be) would make sense if HHS weren’t already overwhelmed by everything else it has to deal with (more than a trillion dollars in spending).
• The proposal still leaves school breakfasts and lunches and commodity programs in USDA, meaning that food assistance programs will still be split between USDA and HHS.
• Downsizing the Commissioned Corps doesn’t make much sense either.  Public health needs all the health it can get.

Whatever happens with this is unlikely to happen quickly.  USDA will not be happy about losing SNAP’s $80 billion a year or WIC’s $6 billion budget.

Many other agencies are also affected by these proposals.  My prediction: Congress will have a lot of trouble coming to agreement on these ideas.

Maybe this is just another attempt to distract us from more pressing matters.

Law Professor Timothy Lytton, an expert on food regulatory policy, has plenty to say about why moving food safety to USDA won’t work (in my paraphrasing):

• Congressional committees are unlikely to support any reorganization that would reduce their power.
• Industry associations are unlikely to support a reorganization that would disrupt their influence with existing agencies.
• The two agencies are different in jurisdiction, powers and expertise; a merger would require a complete overhaul of federal food safety laws and regulations, a task of extraordinary legal and political complexity.
• A merger might create new forms of fragmentation.
• Reorganization is expensive and will take years.  The payoff is unclear.

As I’ve explained before, plans for a single food safety agency have been in the works for years, but have encountered many barriers.  The Food Safety Modernization Act was meant to be step #1 in a three-step process:

1. Pass and implement rules governing FDA’s oversight of pretty much all foods except meat and poultry (this is now done).
2. Fix USDA’s food safety rules governing meat and poultry so they are consistent with FDA’s (in the talking stage, hopefully).
3. Merge the food safety responsibilities in one agency.

These proposals, alas, ignore step #2.  Good luck with that.

The FDA did something quite unusual.  It issued an apparently frank description of where it is in investigating the Romaine lettuce E. coli outbreak that has sickened 197 people, put 89 in the hospital, and killed five—so far.

It published a chart summarizing what the agency has learned about the various distribution channels along the way to the contaminated lettuce that made people sick.

As the FDA explains:

As can be seen in the diagram, in the current outbreak, and based on the information we have to date, there are still no obvious points of convergence along the supply chain…These pathways lead back to different farms, sometimes many farms, where possibly contaminated lettuce could have been harvested during the timeframe of interest.  The only point of commonality in our traceback efforts to date is that all of the farms are located in the Yuma growing region…What does this traceback diagram tell us?  It says that there isn’t a simple or obvious explanation for how this outbreak occurred within the supply chain…The contamination likely happened at, or close to, the Yuma growing area.  Our task now is to investigate what happened.

I used “apparently” with reference to the FDA’s frankness because food safety lawyer Bill Marler, who represents many of the victims of this outbreak,* points out that the FDA must know the names of the farms, distributors, and sellers of the contaminated lettuce, but refuses to say who they are.  Of his own work, Marler says:

We are in the unique position to know many, but not all, of the “points of sale” – restaurants and grocery stores – involved in the E. coli O157:H7 outbreak linked to romaine lettuce. Having over 100 clients allows us to dig deep into their purchase history and consumption history.

We have already determined clusters of illnesses linked to Panera, Texas Roadhouse, Red Lobsters and Papa Murphy’s. We also have identified a processor – Freshway Foods.

If you knew the names of places selling contaminated lettuce, wouldn’t you have sense enough not to eat in them?

• Here is Marler’s video of one of the children sickened in this outbreak.  Heartbreaking.

You have to have some sympathy for egg producers.  Egg consumption has been declining for years.

Egg producers blame the decline on cholesterol concerns; eggs are by far the largest dietary source of cholesterol.

Now Pete and Gerry’s Organic Eggs is petitioning the FDA to forget about cholesterol and update its definition of “healthy” so the company can advertise its eggs as “healthy.”

FDA Commissioner Scott Gottlieb said in a speech last month that the FDA would be updating the definition.

I, of course, think “healthy” is a slippery slope best avoided, and that Congress never should have allowed health claims on foods in the first place.,

But too late for that.

I don’t envy the FDA’s challenge here.  The petition is based on the dietary guidelines, but what the guidelines say about dietary cholesterol, and therefore eggs, is extremely confusing.

As I explained in a previous post, the guidelines no longer recommend a cap on dietary cholesterol of 300 mg/day (the equivalent of 1.5 eggs), but do say that people should eat as little cholesterol as possible.

Good luck on this one.

On May 4, the FDA gave food companies a gift when it announced a 1.5-year extension of compliance dates for the Nutrition Facts label.

We are taking this action because, after careful consideration, we have determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.

On its website, the FDA now says:

The FDA extended the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule, from July 26, 2018 to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply – until January 1, 2021.

CSPI, understandably, is miffed:

The reality is that the labels are already on more than 29,000 products on grocery shelves, and more appear weekly.  So today’s announcement should be a call to action for companies to provide consumers the information they want now, rather than waiting for the legal deadline.