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It’s hard not to think of multivitamin supplements (which also include minerals) as perfectly safe, since the amounts of specific nutrients rarely exceed recommended levels.  But according to recent reports, formulation mistakes get made and these don’t always get caught by quality controls.  Here are two examples.

According to FoodProductionDaily.com, 25% of Adverse Event Reports (AERs) sent into the FDA last year concerned multivitamin supplements. This, says one supplement trade association, should not be interpreted to mean that there is anything wrong with the supplements.  Maybe not, but how about checking?

I say this because of the high zinc levels in the Nutro pet food recently recalled by Mars (see previous post).  Thanks to Sophie for sending a link to a report that some bags of the kibble contained zinc at more than 2000 ppm as compared to the 75 ppm that is supposed to be there.   This, of course, is why I keep insisting that everyone, not just pet owners, should be concerned about the quality of pet food.  We only have one food supply.  If a problem exists with pet food, it’s quite likely that something similar could happen to ours.

The take-home lessons:

• For food manufacturers: Don’t trust the suppliers of vitamin/mineral mixes; test them!
• For the government: How about requiring all supplement manufacturers to follow HACCP (science-based food safety) plans, with testing and quality control.
• For customers (this means you): Contact the consumer affairs representative listed on the package label, ask if the company tests vitamin and mineral levels in finished products, complain if it doesn’t, and demand to see test data if it does.

Addendum: October 16, 2009: Thanks to Anthro for sending a link to this October 7 article from the website of the New England Journal of Medicine: “American roulette – contaminated dietary supplements.”   This is only to be expected from deregulated industries.

If the FDA is now going after health claims (see yesterday’s post), will it also start going after dietary supplements?  These, as I explained in my most recent column in the San Francisco Chronicle, get to make all kinds of unsubstantiated claims without the FDA being able to do much about them.  More and more evidence is coming in suggesting that supplements can be harmful as well as ineffective.   The latest example: antioxidant supplements are said to interfere with the beneficial effects of physical activity.    Will such studies encourage the FDA to insist that manufacturers demonstrate safety and efficacy before they put supplements on the market?  That would be a refreshing change, no?

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.

In early April, the New York Times briefly reported the results of an eating behavior experiment.  Investigators asked college students to choose foods from menus that differed in only one feature; one menu offered a salad and the other did not.   The point?  To find out whether the presence of a salad on the menu influenced what else the students ate.   It did.   The students choose French fries more often from the menu with the salad.  The authors’ interpretation: the “health aura” of salads gives people permission to indulge.  Their paper will be published in the Journal of Consumer Research.

Health aura explains a lot about current food marketing trends.  You may have noticed that vitamins, antioxidants, and omega-3’s are added to everything these days.  Coupled with the downturn in the economy, health aura does wonders for sales of dietary supplements.  Despite underwhelming evidence for their effectiveness, supplements fly off the shelves.  They cost a lot less than health care (and, perhaps, do less harm).

The Government Accountability Office, the agency that keeps a close eye on government integrity, says the FDA ought to be doing a much better job of regulating dietary supplements.  It grants that the FDA has taken “some” or “limited” action to go after potentially unsafe products,  of which, apparently, there are plenty.  The agency, it says, cannot do its job because it lacks resources and recall authority and gives supplements too low a priority.

This is old news, but the report provides an excellent summary of the history and current status of the dietary supplement industry and its regulation.  As is typical of GAO reports, the clarity of presentation is exceptional.  Here’s  what the New York Times reporter says about it.

The National Center for Complementary and Alternative Medicine has released its annual statistics on use of such therapies.  I love the definitions: complementary therapies are used along with conventional medicine; alternative is in place of, and integrative uses both.  And here’s what everyone is using:

Investigators keep trying to find health benefits from taking supplements of vitamins A, E, and beta-carotene but keep coming up with the same conclusion: antioxidant supplements do no good and – worse news – appear to cause harm.   Here we have the single-nutrient problem again.  When in doubt, get nutrients from foods.

I guess the world needs this. I know that lots of people think glucosamine helps relieve their arthritis pains, especially in the knees, but the science on it is really iffy. Any number of reviews conclude that glucosamine is ineffective but safe as a placebo. Well, at least you can get it now from vegetarian sources, made in China. Reassured? The manufacturer says “Most of the world’s glucosamine is manufactured in China anyway. What we’re doing is supplying a safer and purer glucosamine coming from the same geographical location.”