Currently browsing posts about: FDA

In 2012, ConAgra petitioned the FDA to approve use of a health claim on labels and advertising for its whole grain products.  Here’s what ConAgra asked for:

Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.

or

Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.

To say that the FDA was less than impressed with evidence supporting this claim is to understate the matter.  After a comprehensive review of the evidence, here’s what the FDA says ConAgra can use:

Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.

or

Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.

No, this is not a joke.

Congress insists that the FDA must approve health claims, whether supported by science or not.

According to FoodNavigator, ConAgra is happy about this decision.  The first thing anyone will read is “whole grains may reduce the risk of type 2 diabetes.”

As I keep saying, health claims are about marketing, not health.  And qualified health claims are the worst examples.  A plague on all of them!

I was invited to write the editorial to accompany a study published today in JAMA Internal Medicine looking at the highly conflicted process used to decide whether food additives are Generally Recognized as Safe (GRAS).

Here’s the study.

Here’s my editorial.

I know this sounds completely crazy, but here’s what the study found:

• Manufacturers get to decide whether food additives are safe or not.
• Manufacturers get to decide whether to bother to tell the FDA the additives are in the food supply.

And if they do volunteer to inform the FDA (and many do),

• Manufacturers get to decide who sits on the panels that review the evidence for safety.

In reading the study, it seemed to me that:

• As long as not too many people roll over dead after eating foods with new additives, nobody will ever have a clue whether the additive is safe.
• The regulatory gap has spawned an entire enterprise of GRAS consultants and GRAS consulting firms who are in the business—presumably lucrative—of providing the scientific documentation the FDA needs to determine additive safety.

Some of the consultants need to do a better job.  The FDA raises enough questions that about 15% (my estimate) of the requests would be denied.

The good news: If the FDA sees the safety documentation, it does its job.

But what happens to the rejected additives?  Or the ones that don’t get voluntarily sent to FDA?

Nobody really knows (think: caffeine in alcohol drinks–the FDA had no idea).

We need a better food safety system in this country and conflicts of interests in GRAS additive approvals are a good place to start.

Here’s what USA Today has to say about this (I’m quoted).

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

FDA’s documents on the gluten-free rule:

• FDA: Gluten-Free Labeling
• FDA: Gluten-Free Labeling Final Rule Q&A
• Consumer Update

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:

• FDA Food Safety Modernization Act (FSMA)
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
• Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• Fact Sheet: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
• Fact Sheet: Proposed Rule on Accreditation of Third-Party Auditors 
• Consumer Update

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

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.

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?

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:

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:

• Nutrition Calculator
• Interactive Label
• Nutrition Quiz
• Information for professionals
• Spanish-language version

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.

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.