Currently browsing posts about: FDA

I haven’t said anything about pet food in a while, but plenty is happening with it since my pet food books came out—Pet Food Politics (2008) and Feed Your Pet Right (2010).

A few items I’ve collected over the past month or so.

• FDA regulations: The FDA finally issued its proposed rule for processing standards for all facilities engaged in manufacturing, processing, packing or holding animal feed and pet food.  These include  Good Manufacturing Processes (GMPs) and risk-based preventive controls (formerly known as HACCP), among other provisions.
• Safety tips: Food Safety News lists ten ways to make pet food safer—pay attention and follow food safety procedures diligently, for one thing.
• Double standard: Bill Marler complains that the FDA is constantly announcing recalls of Salmonella-contaminated pet foods, even though few of them result in cases of Salmonella in pets or humans, whereas foods for humans take forever to get recalled even when they cause illness.
• Pet food recalls: The FDA certainly lists plenty of pet food recalls, and even has a web page for them.
• FDA oversight: The FDA is on the job and testing.  Bravo issued recalls because of potential Listeria contamination.  It did so because the FDA says an independent lab detected the bacteria in a sample.
• Marketing wars: Pet Food Industry, the excellent publication for manufacturers, has a juicy story about the marketing claims war between Nestlé (no relation) Purina PetCare and Blue Buffalo.  Each has sued the other.  Blue Buffalo has already been called on its advertising claims, perhaps in response to a complaint from  Hill’s Pet Nutrition.
• The ongoing mystery: Pet jerky treats, mostly imported from China, linked to at least 3 human illnesses and more than 1,000 dog deaths and 4,800 dog illnesses, mostly from gastrointestinal problems, liver and kidney disease, and neurological and skin conditions.  The FDA says it still can’t figure out the cause, despite 7 years of trying. symptoms in their pets,” said FDA.

If we can’t get pet food right, there’s not much hope for human food either.

Good try FDA.

ProPolitico Morning Agriculture has a story today that surprises me.  Food companies are opposing the FDA’s proposal to revoke the GRAS status of trans fats (see previous post).

Why am I surprised?  I thought we were done with this one.  I didn’t think it was all that difficult to find substitutes for partially hydrogenated oils.  When trans fats went on food labels, most companies didn’t take long to go trans-fat free.

Now food companies are complaining that the FDA has gone too far, needs to allow companies to keep small amounts in foods, and doesn’t really have the authority to revoke GRAS status.

Among the 1600 comments received by the FDA are these:

• ConAgra Foods
• Nestle (no relation)
• The Schwan Food Company,
• Archer Daniels Midland
• Grocery Manufacturers Association (GMA).  Note: its comment is 104 pages.
• Food Marketing Institute

Writing in favor of the revocation are:

• Center for Science in the Public Interest
• Academy of Nutrition and Dietetics

As a reminder of what this is about, here’s a taste of what I said about trans fats in What to Eat:

Trans fats are not normal.   Hydrogenation causes some of the hydrogens in unsaturated and polyunsaturated fatty acids to flip abnormally from the same side of the carbon chain (in Latin, “cis”) to the opposite side (“trans”).   The normal cis unsaturated fatty acids are flexible, which is why they are liquid; they bend and flow around each other.   But the change to trans causes unsaturated fatty acids to stiffen.  They behave a lot like saturated fatty acids in the body, where they can raise cholesterol levels and increase the risk of heart disease.

Mind you, this is not new information.   My trans fat file has papers on heart disease risk dating back to the mid-1970s.   In 1975, for example, British scientists suggested that one reason poor people in England had higher rates of heart disease was that they so often ate fish-and-chips fried in partially hydrogenated oils.   Since then, researchers have consistently found trans fats to be just as bad–or worse–than saturated fats from the standpoint of heart disease risk.

The recent meta-analysis says much the same thing.

Let’s get rid of trans fats once and for all and be done with them.  I hope the FDA holds firm on this one.

Yesterday, Emily Main of Rodale Press sent me this question:

Have you ever heard of this new “sweetness enhancer” that just got approved by the FDA? It’s called Sweetmyx and is made by a company called Senomyx, and is apparently licensed by Pepsi for exclusive use.  All I can really find out about it is that it enhances the sweet flavor of other sugars, so soda companies can use less sugar in their regular products…Do you have any insight about it?

Nope.  Never heard of it..  All I could find out was that Pepsi had an exclusive deal to use it, according to a Bloomberg report.

Sweetmyx, a new ingredient by Senomyx Inc. (SNMX), received approval for foods and beverages, clearing the way for PepsiCo Inc. (PEP) to use it to make lower-sugar beverages taste sweeter.

The Flavor and Extract Manufacturers Association’s expert panel has determined that Sweetmyx is generally recognized as safe as an ingredient, San Diego-based Senomyx said today in a statement. PepsiCo has the exclusive right to use the product, a so-called flavor modifier, in many nonalcoholic drinks under a 2010 agreement.

While I was trying to discover what Sweetmyx is, exactly, this notice came in from the FDA: 

On March 11, 2014, Senomyx, Inc. issued a public statement suggesting that its food ingredient Sweetmyx (also known as S617) was generally recognized as safe (GRAS). The statement appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination. In fact, the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient. The company’s statement has been corrected and now notes that a third party organization made the determination.

A company can make an independent GRAS determination without notifying the FDA. However, the agency does have a voluntary GRAS notification program whereby a company can inform the FDA of the company’s determination. The FDA maintains an inventory of such GRAS Notices on its website, allowing the public to confirm whether FDA has filed and responded to a GRAS notice.

When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients.

For more information on the GRAS notification process, please see: Generally Recognized as Safe (GRAS).

Recall from one of my previous posts the shocking gap in FDA regulatory authority over GRAS determinations.

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

In the case of Sweetmyx, the company’s consultant says it’s safe so why bother to see if the FDA agrees.

My questions:

• Pepsi: don’t you want FDA approval before putting this stuff in your drinks?
• Chemists: what is Sweetmyx anyway?
• FDA: don’t you think you ought to take a look at this thing?
• Congress: how about insisting that the FDA establish a better system for dealing with food additives

Hey, I can dream.

Additions, March 14:

A reader reminds me that the Center for Food Safety filed a lawsuit to get the FDA to do a better job on GRAS determinations (more information is here).

Another reader points out that Coca-Cola also was flirting with Senomyx a few years ago but evidently gave up the idea.

And another notes that Senomyx’s financial report makes it clear that the company knows it has regulatory issues: “Senomyx may be asked to complete additional studies to evaluate and/or monitor the safety of new flavor ingredients in order to maintain applicable regulatory approvals and/or obtain regulatory approvals outside of the United States.”

Over the weekend, Politico announced that the Grocery Manufacturers Association (GMA) and Food Marketing Institute (FMI) were finally going to launch their long-threatened $50 million campaign to promote voluntary “Facts Up Front” labels on food packages.

In case you never noticed these labels—and I doubt most people do—here is an example:

GMA and FGI conducted their own survey.  This—no surprise—found that people love Facts Up Front labels, but I find that hard to believe.  Neither do others, according to Politico reporters.

For what $50 million will buy, see yesterday’s Washington Post, page A5 (thanks Politico).

Recall the history

Facts Up Front (formerly known as Nutrition Keys), was originally launched as an end run around what the FDA was then trying to do with front-of-package labeling initiatives.  This happened early in 2011.

The GMA/FMI ploy brought the FDA’s initiatives to a halt—despite the agency’s investment in two Institute of Medicine (IOM) studies to establish a research basis for front-of-package labels.

These, in turn, followed on the heels of the food industry’s ill-fated Smart Choices—an attempt to promote highly processed foods as healthy.

GMA/FMI’s goal was to head off any possibility that the FDA would mandate red, yellow, and green traffic light signals.

Red signals might discourage consumers from buying products made by the companies GMA and FMI represent.

The food industry had cause to worry.  The IOM was considering—and eventually published—a front-of-package scheme similar to traffic lights.  It used checks or stars to evaluate the content of calories, saturated and trans fat, sodium, and sugars, all nutrients to watch out for.

GMA/FMI got its much more complicated—and, therefore, harder to understand—Nutrition Keys out first.  This preempted the IOM recommendations.

The FDA gave up.  The two IOM reports went into a drawer and the FDA has done nothing with them.

Why is GMA/FMI doing this now?

Surely, it is no coincidence that GMA/FMI is rolling out this campaign on the heels of Let’s Move!’s triumphant release of the FDA’s new food labeling proposals.

They must be worried that the FDA will unearth the two IOM reports, adopt the IOM recommendations, and start rulemaking for front-of-package labeling.

One sign of the food industry’s strategy comes from Bruce Silverglade, who for years was head counsel for the Center for Science in the Public Interest (CSPI), but has now revolved to a Washington, DC law firm that represents food companies.  He told Politico:

The general view in the industry is that nutrition information has really moved to the front of the pack. What FDA is doing is essentially proposing a new model of an old dinosaur.

As Michele Simon tweeted: “that comment…is rich coming from ex-@cspi lawyer who fought for label.”

What’s wrong with Facts Up Front? 

Plenty.

The IOM recommended that front-of-package labels be:

• Simple: easy to understand
• Interpretive: putting judgments in context
• Scaled: indicating good, better, and best

Facts Up Front does none of the above.

Facts Up Front is a tool for selling, not buying.

Its purpose is to make highly processed foods look healthier, whether or not they really are.

Whether slightly better-for-you processed foods will help anyone make better food choices and be healthier remain open questions.

What should happen now?

With Let’s Move! really moving, this seems like a great time to urge the FDA to pull out those IOM reports and get busy on a front-of-package labeling method that will really help the public make healthier dietary choices.

Release of the FDA’s proposals for revisions of the Nutrition Facts label got, to say the least, lots of attention.

A few items need some follow up.

The politics

The best discussion of the First Lady’s involvement in the new food label comes from Helena Bottemiller Evich at Politico:

• On yesterday’s release
• On Mrs. Obama’s emerging role in nutrition policy
• On the likely effects of the new label on the food industry

The reaction of the Grocery Manufacturers Association (GMA)

How’s this for a brilliant response?

We welcome First Lady Michelle Obama’s announcement of the proposed updates to the Nutrition Facts panel and thank her for her leadership on this and broader health issues.  The nation could not ask for a more thoughtful, effective or passionate advocate than Michelle Obama.

For 20 years, the Nutrition Facts panel has been an invaluable tool to help consumers build more healthful diets for themselves and their families, and the time is right for an update.

Diets, eating patterns and consumer preferences have changed dramatically since the Nutrition Facts were first introduced.  Just as food and beverage manufacturers have responded by creating more than 20,000 healthier product choices since 2002, and by providing tools like Facts Up Front front-of-pack labels, the FDA is responding with a thoughtful review of the Nutrition Facts panel.

We look forward to working with the FDA and other stakeholders as these proposed updates to the Nutrition Facts label make their way through the rule making process.

It is critical that any changes are based on the most current and reliable science.  Equally as important is ensuring that any changes ultimately serve to inform, and not confuse, consumers.

How you can file comments

A frustrated reader complains that he can’t find information on the FDA’s website about how to file comments.     That’s because the proposals haven’t been published yet.

They are scheduled for publication in the Federal Register on March 3.  Look for instructions then.  After that, the FDA will collect comments for 90 days.

Two sets of proposed rules will be open for comment:

• Food Labeling: Revision of the Nutrition and Supplement Facts Label  (367 pages)
• Serving Sizes of Foods that can Reasonably be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (145 pages)

Start drafting comments now!

Congress can’t pass a farm bill but it has plenty of time to micromanage nutrition and health.  Buried in the pork-filled Consolidated Appropriations Act of 2014 (see Monday’s post) are some zingers.  Here’s one:

This refers to the ill-fated IWG report I’ve discussed previously. To recap:

• Congress asked the FTC to examine the effects of food marketing to children and make recommendations.
• The FTC, USDA, FDA, and CDC got together and produced a report recommending voluntary guidelines for marketing to children based on the nutritional quality of the foods.
• I thought the guidelines were weak in addition to being voluntary (they allowed lots of junk foods to qualify).
• The food industry disagreed, strongly, and went to Congress to object.
• Congress caved in to industry pressure and said the report could not be released unless the FTC produced a cost-benefit analysis.
• End of story.
• Why Congress feels that it’s necessary to do this again is beyond me.

I suppose we should be glad our legislators are at least doing something.

As for the food industry’s role in all this: when food companies say they are doing everything they can to reduce marketing junk foods to kids, you now know what they really mean.

By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods, energy shots, for example.

Under the law, the FDA pretty much has to keep hands off of supplements, except when something egregious happens, like people getting sick or dying.

The FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs.  It just issued:

• Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages
• Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages

These documents, however, are guidance.  The are not regulations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Why is FDA doing this?  I’m guessing for two reasons.

1.  The weird ingredients in energy drinks:

We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods. 

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.

2.  The high caffeine levels in those drinks.

Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks.

But the levels in energy drinks are so much higher that the FDA has questions about whether GRAS applies to them.

These guidance documents are open for comment.  If you care about such issues, weigh in now.

In the strange way the U.S. government works, Congress has produced the “Consolidated Appropriations Act of 2014,” which authorizes payments for government services, including those related to agriculture.

This is not the farm bill.  It’s what Congress decides taxpayers will pay for in the farm bill as well as bills that cover other programs run by USDA.

The House summary of agriculture appropriations is a lot easier to read than the bill itself, although it contains its share of double speak.  Try this:

WIC – This program provides supplemental nutritional foods needed by pregnant and nursing mothers, babies and young children. The bill provides full funding for WIC at $6.7 billion – $153 million below the fiscal year 2013 enacted level…This level will ensure all eligible participants will be served.

Can someone please explain to me how a cut of $153 million will ensure service to everyone who is eligible?  WIC is not an entitlement; eligible people cannot be served once the money runs out.

The bill does provide full spending—$82.2 billion—for SNAP, but only because it has to.  SNAP is an entitlement and spending for it is mandatory.  Unless, of course, Congress ever passes the farm bill, which currently contains a $9 billion proposed cut.

And here’s more double speak.  “The legislation includes several provisions to reduce spending and increase oversight of taxpayer dollars.”  How?  By authorizing spending for:

• Oversight and monitoring requirements for the WIC program, including a directive for the Secretary of Agriculture to increase oversight of vendors to help rein in food costs;
• A provision requiring USDA to submit a plan for reducing high error rates and improper payments in the National School Lunch and School Breakfast Programs;
• Requirements for the Secretary of Agriculture to help weed out and eliminate waste, fraud, and abuse in the SNAP program – including a directive to ban fraudulent vendors, and a prohibition on advertisements or outreach with foreign governments.

And why does the FDA’s budget still get decided by committees dealing with agricultural appropriations?

The FDA is a public health agency in the Department of Health and Human Services, which is funded by entirely different committees which you might think understand its mission a lot better than committees fussing about legislation that

restricts the Grain Inspection, Packers and Stockyards Administration (GIPSA) from implementing certain regulations that would allow harmful government interference in the private market for the livestock and poultry industry.

I can hardly wait to see what the farm bill will look like.