Currently browsing posts about: Omega-3-fats

The FDA just announced that it is planning to research health claims on infant formulas such as “supports brain and eye development.’’ The FDA wants to:

assess women’s understanding of and response to various statements on infant formula labels. The study results will be used to help the Agency to understand the role that certain types of statements on infant formula labels have in influencing formula choice….The study will focus on purchase choice, perceived similarity of the formula to breast milk, and perceived likelihood that the formula has certain health benefits.

Translation: the FDA thinks that claims for omega-3 fatty acids—DHA, in this case—on infant formulas mislead mothers into thinking the formulas are better than breast milk.

Despite lack of evidence for benefits, infant formula makers have been so successful in marketing the addition of these omega-3 fatty acids that you can hardly buy a formula without them.

I was in Ecuador a few months ago and saw this sign:

The idea?  Omega-3’s will make your kid smart.

My book, What to Eat, has a chapter on infant formula and baby food. Here are some relevant excerpts:

Infant formulas cause controversy and are endlessly contentious for three important reasons. Formulas are (1) largely unnecessary (most mothers can breast feed their infants), (2) not as perfect as breast milk for feeding babies, and (3) more expensive than breast feeding.

Breast milk is nutritionally superior to formula, but from a marketing standpoint it has one serious disadvantage: it is free. Beyond one-time purchases of breast pumps, storage bottles, or special clothing, nobody makes money from it.

For mothers who cannot, should not, or do not want to breast feed, formula is a socially and nutritionally acceptable substitute. But formula companies do not only promote formulas to mothers who must use formula. In subtle and not-so-subtle ways, they promote the use of formulas to all pregnant women and new mothers.

I go on to explain that because formula is the sole food for infants, its composition is highly regulated. Therefore, all infant formulas have the same composition, and all virtually indistinguishable.

Competition for market share explains why formula companies want to put distinctive nutrients in their formulas–especially nutrients considered “conditional.” A conditional nutrient is one that might have some benefits under some circumstances. Even if the health benefits are minimal or questionable, they can be used in advertising.

That is the principal reason why so many formulas now have fatty acids added—omega 6 arachidonic acid (ARA) and omega-3 docosahexaenoic acid —the same one that is in fish oil. These two fatty acids are normally present in breast milk, and there is some evidence, weak and questionable as it may be, that they support infant brain development and vision.

Formula makers got the FDA to agree that ARA and DHA are normal components of food (which they are) and, therefore, are Generally Recognized As Safe (GRAS). This means that companies could add ARA and DHA to infant formulas without having to prove that either of them really did anything useful or beneficial.

I then explain that the FDA apparently agreed to the GRAS petition with some reluctance, as indicated by its answer to the question, “What is the evidence that addition of DHA and ARA to infant formulas is beneficial?”

The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.

My interpretation of the proposed research study is that the FDA thinks the addition of ARA and DHA may discourage mothers from breastfeeding and may unnecessarily cause them to buy more expensive formula.

If you agree, tell the FDA you think the study is a great idea, and the sooner it gets going, the better.

You can file comments at http://www.regulations.gov.  Refer to Docket No. FDA–2011–N–0098]

In its continuing effort to crack down on companies making deceptive claims that omega-3 promotes healthy brain and eye development in children, the FTC has just announced deceptive advertising charges against NBTY, a marketer of children’s vitamins.

In February, the FTC  issued warning letters to 11 companies that make products like this one (“pediatrician recommended,” yet).

The FTC said the companies had better get busy and make sure they are not violating the law by “making baseless claims about how the supplements benefit children’s brain and vision function and development.”

The FTC cautioned the companies to make sure they had:

“scientific evidence to support claims that their products boost, improve, enhance, or support brain and vision function and development in children…[and]claims relating to intelligence, cognitive function, learning ability, focus, mood, memory, attention, concentration, visual acuity, and eye health.”

Now, the FTC has reached a settlement with the companies for $2.1 million in refunds, not only because of the unsupported health claims but also because the products did not contain the advertised amount of omega-3’s (see legal complaint):

the multivitamins featured characters such as the Disney Princesses, Winnie the Pooh, Finding Nemo, and Spider-Man.  Product packaging and print ads promoting the vitamins had bold graphics highlighting that the products contained DHA, but in reality, the products allegedly had only a trace amount of DHA.

While the vitamins’ packaging touted the purported health benefits of 100 milligrams of DHA, a daily serving of the Disney and Marvel multivitamins for children ages four years and older contained only one thousandth of that amount (0.1 mg or 100 mcg), according to the FTC’s complaint.

The settlement:

• Bars NBTY, NatureSmart, and Rexall Sundown from misrepresenting the amount of any ingredient contained in any product.
• Bars them from misrepresenting that any ingredient, including DHA, promotes brain or eye health or provides any other health benefit, unless the claim is true and backed by competent and reliable scientific evidence.

• Specifies that any violations could subject the NBTY, NatureSmart, and Rexall Sundown to civil penalties.

I wonder if the FTC is taking a look at the DHA “brain development” claims for Nestlé’s Juice Juice?  Just a thought.

This just in: The FTC announces a settlement with Dannon Yogurt to stop making unsubstantiated, exaggerated health claims for activia.  Dannon may no longer claim that:

• Any yogurt, dairy drink, or probiotic food or drink reduces the likelihood of getting a cold or the flu (unless FDA says it’s OK)
• Activia yogurt will relieve temporary irregularity or help with slow intestinal transit time, unless the ad conveys that three servings of Activia yogurt must be eaten each day.
• Any other yogurt, dairy drink, or probiotic food or drink will relieve temporary irregularity or help with slow intestinal transit time unless the company has two well-designed human clinical studies that substantiate the claim.
• The health benefits, performance, or efficacy of any yogurt, dairy drink, or probiotic food or drink, unless the claims are backed by competent and reliable scientific evidence.

The FTC wants science to back up health claims.  What a concept!

If you don’t have a small baby, or your baby is breastfed(and see note at end) you no doubt are missing the furor over “functional” ingredients that companies have been adding to infant formulas.

DHA (an omega-3 fatty acid) came first.  As I discuss in my book, What to Eat, infant formula companies could not wait to add it.  They knew they could market it on the basis of preliminary evidence associating DHA with visual and cognitive benefits in young infants.    Although evidence for long term benefits is scanty, the companies also knew that they could charge higher prices formulas containing DHA.

The FDA approved the use of DHA in infant formulas on the grounds that it is safe, but did not require the companies to establish that DHA makes any difference to infant health after the first year.  Because of its marketing advantage, virtually all infant formulas now contain DHA.  Surprise!  They also cost more.

Companies now want to add other ingredients, such as prebiotics, probiotics, lutein, lycopene, and betacarotene, which also can be marketed as healthier and at higher prices.

In response, the Center for Budget and Policy Priorities (CBPP), has issued a report on the lack of evidence for the benefits of functional ingredients and the substantial harm they will cause to the economic viability of the WIC program, the USDA’s assistance program for low-income mothers and children.

WIC buys about half the infant formula sold in the United States each year.  WIC is not an entitlement program, meaning that the number of participants is limited by available funding (a GAO report explains how this works).

The CBPP report says:

As pressure mounts to limit federal discretionary spending, it is critical to ensure that WIC not spend funds on foods with functional ingredients that do not deliver clinically significant benefits. WIC spent approximately $850 million on infant formula last year, and a recent USDA study found that more than ten percent of that spending ($91 million annually) is attributable to higher-priced formulas with functional ingredients.  Under current law, the additional cost to WIC of providing foods with these ingredients is likely to grow substantially as such foods proliferate.

As the report explains, formula companies do not have to demonstrate that the added–and more expensive–ingredients do any good:

There is no mechanism within the national WIC program that requires USDA to review the research evidence on the claimed benefits of these functional ingredients or to base decisions about whether to offer foods containing such ingredients on their benefits and the specific needs of WIC participants. Currently, instead, infant formula manufacturers themselves decide whether WIC offers infant formulas with new functional ingredients, while state WIC programs decide whether WIC should offer other foods with such ingredients.

As I keep saying, functional foods (and ingredients) are about marketing, not health.  If companies are going to add functional ingredients–and charge higher prices–they need to have some convincing scientific evidence to back up their claims.

Postscript: Laurie True of the California WIC program writes:

Congressman George Miller, Chair of the House Education and Labor Committee, is writing the bill that reauthorizes the WIC Program this week. He should include a provision requiring independent scientific review of the efficacy of these “functional ingredients” before USDA allows them in WIC foods and infant formula.

Note:  Lori Dorfman sends a Berkeley Media Studies Group issue paper on how to advocate for hospitals and workplaces to make it easier for moms to breastfeed.

The European Food Safety Authority (EFSA) has just rejected a proposal from Merck to allow it to use a health claim stating that omega-3 supplements promote  eye and brain health in infants.  Merck wants moms to take omega-3 supplements during pregnancy and give such supplements to their infants.  EFSA reviewed nearly 90 studies on this topic and concluded that the study results were not “informative.”    In other words, they showed no benefit.  Imagine.  The EFSA demands scientific substantiation of health claims.  I wish we could do that.

Here’s another example from the pomegranate folks.  They do brilliant advertising, but this time the British are complaining that these marketers went too far when they posted billboards stating that pomegranate (“antioxidant powerhouse”) juice will help you cheat death.  The British advertising standards agency balked.  Here too, pesky science gets in the way.  Studies not only fail to support a benefit of antioxidants but sometimes show harm.

Our Congress, however, forces FDA to permit health claims, no matter how absurd.  Try the FDA-allowed “qualified” health claim for omega-3’s: “supportive but not conclusive evidence  shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” [my emphasis].  The FDA allows omega-3’s to be added to infant formulas, but here’s what it says about them:  “The scientific evidence is mixed…There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.”

The EFSA interprets all this as unworthy of a health claim.

What can the FDA do?  If it says there isn’t enough evidence, it gets sued and loses.  The courts tend to rule that food companies can say whatever they like about health benefits on the grounds of free speech and the First Amendment.

In January, the FDA published “guidance” for industry about how it plans to evaluate the scientific basis of health claims.     Guidance is just that.  It is non-binding.

Hello new administration.  How about taking a fresh look at the health claims situation and paying close attention to what regulators in Europe are doing.  How about considering just saying no to health claims.

Yes Virginia, there is indeed a trade association for everything and omega-3 fats have their very own.  This one is hard at work trying to get the FDA to approve a full health claim (as opposed to the current qualified claim) for omega-3 fatty acids and heart disease risk.  The FDA now allows this statement: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” (my emphasis). I can understand why the omega-3 industry wants something stronger.  Health claims, as I keep insisting, are about marketing, not health.

Thanks to Dr. Freedhoff for passing along his Weighty Matters blog post about Voortman’s new Omega-3 Zeer-Oh cookies. He got them in Canada. Maybe we will get to have them here soon? OK, so sugar is the first ingredient. But they are “Zero grams trans fat!”

My latest interview with Eating Liberally is now posted. This “Ask Marion” delves into how to figure out the risks and benefits of eating raw fish: methylmercury (risk) v. omega-3 fats (benefit). It is also posted on Huffington, in the Living Now section.

A reader in California writes: Hello, I am reading your book, what to eat, overall I am very much enjoying it, but I have noted a few things that I have to disagree with you on. One in particular regards Flaxseeds as a source for Omega-3 fatty acids…I am well aware that Flaxseeds are a great source of Omega-3 fatty acids, but they also have a very dense husk. My understanding is that if you eat the Flaxseeds in their whole form your digestive system is not able to breakdown the outer casing of the seeds and allow for the absorption of the fatty acids contained inside…You seem to believe that you can absorb the fatty acids in flaxseeds while they are in their whole form and I would love to hear back from you about the basis for your opinion.

My response: The writer is referring to a comment in What to Eat about a cereal said to contain 2,000 milligrams of omega-3 fatty acids per 2-ounce serving. The question is whether any of that is usable. I would assume that the seeds have been broken during processing so that some of their fats can be absorbed, but I am unfamiliar with research on this question. Readers: do you know anything about this? If so, please post.