by Marion Nestle

Currently browsing posts about: FDA

Jul 29 2013

FDA’s latest round of food safety proposals: food imports

The FDA has finally released safety rules for imported foods, two years after Congress passed the food safety law.  OK.   We now have them.  At last.

Here’s what the FDA is up against:

  • 150 different countries ship foods to the U.S.
  • These account for about 15% of the food supply, but 50% of fresh fruits and 20% of fresh vegetables.
  • The agency has the capacity to inspect about 2% of imported foods.

To deal with this disconnect, the FDA proposes to hold importers accountable for the safety of what they ship to us.

The proposed rules allow two ways to do this: Importers can do their own onsite safety audit, or they can verify that their suppliers did so.

Both methods involve verification by certified verifiers that suppliers used “prevention-oriented food safety practices” (HACCP in other words), and achieved the same level of food safety as domestic growers and processors.

Neither requires inspection by FDA, although importers may use inspection.

The proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days.

The previous proposed rules, for produce safety and food production facilities (see below), have been given another 60 days for public comment.  Comments on all proposals will now be due at the same time.  The FDA expect to issue the rules 12 to 18 months after the comments come in and then it will take another 18 months for rules to go into effect.

What does all this mean?

The FDA hardly has the resources to manage U.S. inspections so expecting it to do foreign inspections is unrealistic.  This plan shifts the regulatory burden to producers and shippers (why does this sound like foxes guarding henhouses?).

The FDA also intends to certify third-party auditors.  These invariably involve conflicts of interest, although that system  seems to have worked fairly reasonably well for organic foods.  But we are talking about the safety of imported foods here, and lives are at stake.

This is undoubtedly the best the FDA can do given its limited resources and its problems with Congress.  This Congress is hardly likely to view food safety as a national priority and give the FDA what it needs.

Recall: FDA appropriations go through agricultural appropriations committees, not health appropriations.  And this Congress cannot even pass a decent farm bill.

Congratulations to the FDA for making the best of a bad situation.  And fingers crossed that the proposals survive, get implemented by 2015, and nothing bad happens in the interim.

The document collection:

For a detailed discussion of the pros, cons, and questions, see the account in Food Safety News

May 13 2013

FDA is on the job: health claims

The FDA has sent a warning letter to a supplement manufacturer, Europharma, to cease and desist making health claims for several of its products.  The company, says the FDA, is promoting these products

for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act…because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

For example:
  • The Calm Kids web page links to articles that say “In clinical trials of children with ADD, phosphatidylserine was able to improve attention and reduce symptoms. In fact, 11 of 18 children receiving phosphatidylserine had no further ADD symptoms at all.”
  • The CholestCaps web page links to an article that says “Indian Gooseberry [ingredient in CholestCaps formula]…reduces symptoms of allergies, particularly hay fever [. . .].” and “Indian Gooseberry has proven beneficial in all the disease conditions tested so far [. . .].”
  • The CuraMed web page links to articles that say “Today, we extract curcumin [primary ingredient in CuraMed] from turmeric to use as a natural medicine for cancer, Alzheimer’s disease, arthritis, and many other chronic diseases.”

What’s interesting about this is that the focus is on what the articles say, not what is stated on the website.  This is a new approach for FDA and it will be interesting to see if it works.

According to FoodNavigator.com, Europharma is filing objections, is not admitting wrongdoing, but has removed links to the offending literature from its website.

Progress?

May 9 2013

Wrigley’s withdraws caffeinated gum out of respect for the FDA

The Associated Press says Wrigley’s will temporarily cease and desist trying to market caffeinated gum (see previous post).

The company said Wednesday that it has stopped new sales and marketing of Alert Energy Caffeine Gum “out of respect” for the agency…”After discussions with the FDA, we have a greater appreciation for its concern about the proliferation of caffeine in the nation’s food supply…”

Temporarily?

FDA Deputy Commissioner for Foods and Veterinary Medicine issued this statement:

On May 8, 2013, Wrigley (a subsidiary of Mars) announced its decision to pause production, sales, and marketing of Alert Energy Caffeine Gum. This announcement was made following a series of discussions with the FDA in which the agency expressed concerns about caffeine appearing in a range of new foods and beverages.

The FDA applauds Wrigley’s decision and its recognition that we need to improve understanding and, as needed, strengthen the regulatory framework governing the appropriate levels and uses of caffeine in foods and beverages. The company’s action demonstrates real leadership and commitment to the public health.

We hope others in the food industry will exercise similar restraint….

Congratulations to all concerned.  It’s good to see the FDA on the job.

For an instant explanation of what this is about, see the Wall Street Journal’s elegant illustration:

image

 

May 7 2013

Grocery Manufacturers Association says: Eat less, move more (it’s your fault, not ours)

The Grocery Manufacturers Association (GMA) recently released an interactive  guide to using Facts Up Front, its front-of-package nutrition symbols.

Here’s an excerpt from the GMA’s Infographic:

The GMA’s press release said Facts Up Front

empowers consumers to make informed choices. It arms them with critical nutrition information about their favorite products…Through this website, we are providing consumers with the knowledge and tools they need to build a healthful diet.

The website includes, among other things:

The GMA says:

Facts Up Front labels…highlight nutrition information – calories, saturated fat, sodium and sugar per serving – in a clear, easy-to-understand format. The labels also provide consumers with valuable information about “nutrients to encourage”…The labeling program was developed in response to First Lady Michelle Obama’s call on the food and beverage industry to help consumers construct a healthy diet for themselves and their families.

As I’ve explained in previous posts, I can’t believe that this is what the First Lady had in mind.  I view Facts Up Front as the industry’s end run around the FDA’s long delayed attempt to make front-of-package nutrition information actually useful to consumers.

I’m greatly in favor of eating less, eating better, and moving more as a way to manage weight in today’s food marketing environment.  

But coming from GMA, the message takes on additional meaning: it’s up to you to make healthful food choices.  The companies represented by GMA take no responsibility for the effects of their products on health or of their marketing on your food choices.

Feb 28 2013

Let’s Ask Marion: What’s The Recommended Daily Allowance of Sugar?

Here’s another one of those occasional queries from Kerry Trueman.  This one, posted at Huffington, is about FDA regulations for labeling sugars.

Trueman: I’ve just begun to sink my teeth into Michael Moss’s extraordinary food industry exposé, Salt Sugar Fat: How the Food Giants Hooked Us, a book you’ve rightly lauded as a “breathtaking feat of reporting.” As Moss points out, the FDA is happy to give us guidelines on how much salt and fat to include in our daily diets, but–as a glance at any nutritional label shows–they’ve declined to make any recommendation at all about sugar.

Does this mean that:

(a) It’s OK to eat as much sugar as you like, or:

(b) There may be an unsafe level of sugar consumption, but the FDA just doesn’t have the resources to figure out what that level is, or:

(c) The FDA knows how much sugar we can eat without harming our health, but the food industry won’t let them tell us.

How is the average American supposed to interpret this absence of information?

Nestle: Whoa. Slow down. Let’s back up a minute. The FDA sets nutritional standards for food labels, but the Institute of Medicine (IOM) sets nutritional standards for dietary intake. To understand what’s happening with the FDA and food labels, we have to talk about what the IOM used to call the Recommended Dietary Allowances (RDAs) but now calls Dietary Reference Intakes (which, confusingly, include RDAs and other standards, such as Upper Limits).

In 2002, the IOM set standards for total carbohydrates–sugars and starches (which are converted to sugars in the body). In its review of the evidence, the IOM set the RDA for total carbohydrates at 130 grams a day (roughly 4 ounces) to meet the needs of the brain for fuel. This amount is much less than typically consumed by adults.

As for sugars, the IOM noted that the average intake of sugars among adolescent males was 143 grams per day, and that the heaviest users were consuming 208 grams per day–much more than the amount of total carbohydrate needed.

Since sugars are not required nutrients, the IOM could not set an RDA. And although it did not have enough evidence to set an Upper Limit, the IOM suggested that the maximum level of intake of added sugars (as opposed to those naturally present in foods) should be a whopping 25% or less of calories.

Americans typically consume around 20% of calories from added sugars. Taken at face value, the IOM suggestion made it sound as if current intake levels were just fine. The sugar industry happily viewed 25% as a recommendation, not a maximum.

Before the sugar industry got after them, many countries recommended an upper level of sugar intake at 10% of calories. That’s what the U.S. Pyramid did in 1992.

The sugar industry does not like the 10% recommendation. It means, for example, that just one of Mayor Bloomberg’s 16-ounce sodas takes care of recommended sugar intake for the day.

Robert Lustig, who is largely concerned about what too much fructose does to us, thinks that 50 grams of sugar (sucrose or HFCS) is a reasonable Upper Limit for most people. This would provide 25 grams of fructose, which the body can handle with relative ease. What’s interesting about his cut point is that it means 200 calories a day, or 10% of calories for a 2000 calorie diet. So there we are at 10% of calories again.

If the FDA wanted to be helpful, it could do two things.

1. Require companies to list added sugars under the carbohydrate category on food labels.

2. Set a DV for sugars at 50 grams.

In the meantime, everyone would be healthier eating less sugar. 

Feb 13 2013

Petition to FDA: it’s time to put “added sugars” on food labels

Center for Science in the Public Interest (CSPI) held a press conference this morning to announce that 10 health departments, 20 health and consumer organizations, and 41 health professionals (including me) have signed a letter in support of its petition asking the FDA to:

  • Initiate a rule-making proceeding to ensure that the content of sucrose and HFCS in beverages is limited to safe levels consistent with authoritative recommendations. 
  • Revise the “Sugars” line on Nutrition Facts labels to address “added sugars.”
  • Set targets for lower levels of added sugars in other foods that provide significant amounts. 
  • Conduct a public education campaign to encourage consumers to consume less added sugars.
Why?  Check out CSPI’s infographic:  Sugar: Too Much of a Sweet Thing.
The petition also asks the FDA to work with the food industry to:
  • Limit the sale of oversized sugar-sweetened beverages in restaurants
  • Limit the sale of oversized sugar-sweetened beverages from vending machines
  • Develop means to reduce the use of added sugars.

Our letter of support begins:

The undersigned scientists and organizations are concerned about Americans’ excess consumption of added sugars…Every edition of the Dietary Guidelines for Americans (going back to 1980) has recommended reducing consumption of added sugars, but Americans are consuming more added sugars (including sucrose, high-fructose corn syrup, corn syrup, and other caloric sweeteners) now than they did in 1980. And that high level of consumption…is contributing to serious health problems.

If the situation with trans fats was any indication, the food industry will reduce the sugars in its products if it has to disclose them.

This is not the first time that CSPI has tried to get added sugars labeled (see petition from 1999).  I’m hoping the letter of support will encourage the FDA to take action this time.

Maybe it will even put sugars on front-of-package labels, as the Institute of Medicine suggested in 2011.

Feb 7 2013

Yet another food worry? Nanoparticles.

As You Sow, an advocacy group for environmental corporate accountability, has been paying close attention to nanotechnology.  It has just issued a report, Slipping Through the Cracks: An Issue Brief on Nanomaterials in Foods.

An Issue Brief on Nanomaterials in Foods

 

According to an account in the New York Times, the CEO of As You Sow, Andy Behar, says:

We’re not taking a no nano position…We’re saying just show it’s safe before you put these things into food or food packaging.
Nanotechnology, as I have discussed previously, is the use of tiny particles for many purposes, among them food.  These particles are really, really small, on the scale of nanometers (nm), one billionth, or 10−9, of a meter.
Are they safe to eat?

The FDA’s nanotechnology web page provides a 2007 report from a task force, a 2012 fact sheet, and a draft-for-comment on how industry should deal with nanoparticles in foods and food packaging.

The fact sheet says:

FDA has long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies…The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting also may merit examination to determine any effects on product safety, effectiveness, or other attributes. Understanding nanotechnol­ogy remains a top FDA priority. FDA is monitoring the evolving science and has a robust research agenda to help assess the safety and effectiveness of products using nanotechnology.

My translation: the FDA has no idea whether this technology is safe or not and is depending on industry to find out.

Because the FDA does not require labeling of nanomaterials (the European Union does), you have to decide for yourself whether this is something you want to add to your list of food worries.

Just a thought: real foods don’t have added nanoparticles.

Feb 1 2013

Wonder of wonders: food companies favor GMO labels!

Stephanie Strom reports in today’s New York Times that a group of food companies—among them several that put millions of dollars into opposing California’s Proposition 37 last November—are now favoring labeling of genetically modified foods.

Those companies won the election; Proposition 37 lost, although not by a very wide margin.   

But in the process, two things happened: they lost credibility, and they created a movement for GMO labeling initiatives in other states.

Advocates for GMO labeling figured out that although Big Food and Big Soda were willing to invest $40 million to defeat the California labeling initiative, they might hesitate if confronted with initiatives in many other states.

Good thinking.  Ms. Strom reports the previously unthinkable:

Some of the major food companies and Wal-Mart, the country’s largest grocery store operator, have been discussing lobbying for a national labeling program.

Executives from PepsiCo, ConAgra and about 20 other major food companies, as well as Wal-Mart and advocacy groups that favor labeling, attended a meeting in January in Washington convened by the Meridian Institute, which organizes discussions of major issues.

…“They spent an awful lot of money in California — talk about a lack of return on investment,” said Gary Hirshberg, co-chairman of the Just Label It campaign, which advocates national labeling, and chairman of Stonyfield, an organic dairy company.

…Mr. Hirshberg said some company representatives wanted to find ways to persuade the Food and Drug Administration to proceed with federal labeling.

I have to say that I never thought I’d live to see this happen.  I was one of four consumer representatives to the FDA’s Food Advisory Committee in the early 1990s when the FDA was considering approval of GMOs and whether or not to require them to be labeled.

We warned the FDA that if GMOs were not labeled, the public would wonder what the industry was trying to hide.  This, we said, would not only hurt the FDA’s credibility, but would end up hurting the GMO industry as well.

As I discuss in my book, Safe Food: The Politics of Food Safety, the FDA’s main arguments at the time were that (a) it would be misleading to label GMOs because they were no different from foods produced through traditional genetic crosses, and (b) the process by which foods are produced is not material.

Even then, it was evident that argument (b) made no sense.  The FDA already permitted foods to be labeled as Made from Concentrate, Previously Frozen, Irradiated, and, later, Organic.

As I’ve discussed previously, GMO labeling is no big deal.  All the label needs to say is “May be made from genetically modified corn, soy, or sugar,” as Hershey’s does in Great Britain.

Let’s hope the FDA takes notice.

 

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