by Marion Nestle

Currently browsing posts about: Supplements

Nov 19 2009

Supplement woes, again

The supplement industry has its hands full these days trying to keep up with negative publicity about taking vitamins.    Its latest damage-control efforts are aimed at some Norwegian studies published in this week’s Journal of the American Medical Association (JAMA).  Norway does not fortify foods with folic acid and investigators evidently wanted to know if the vitamin was safe.  They gave various combinations of vitamin supplements to heart disease patients.  Oops.   Patients taking folic acid and vitamin B12 had higher death rates than those taking no supplements or vitamin B6.  The excess deaths were generally from cancer, mostly of the lung.

Implications?  Like all such studies, this one requires interpretation.  The supplement industry has one interpretation.  Others are likely to follow.

But maybe it’s time to think more carefully about adding folic acid to the food supply?  We add folic acid to flour in the U.S. in an effort to reduce prenatal risks for neural tube disease (NTD).  Rates of NTD have decreased with folic acid fortification, but they might have done so anyway.  Maybe taking single vitamins is not such a good idea?  Maybe we need a whole lot more research on mechanisms of action?  Do vitamins promote the growth of cancer cells, for example?  Are people with heart disease especially susceptible to excessive vitamin intake?  And maybe we need stronger regulation of dietary supplements?  What a concept!

For the supplement industry, these kinds of studies mean bad news.  Nutrition Business Journal worries about how such research will affect sales.  Watch the industry spin on this one.

Nov 4 2009

Europe rejects droves of health claims

In what the functional food industry refers to as a “bad day at the office,” the European Food Standards Agency (EFSA) rejected hundreds of health claims, particularly those for probiotics.  More recently, it rejected a claim that glucosamine prevents cartilege degeneration.  Hard as it may be for the food and supplement industries to believe, EFSA just can’t find scientific evidence to support those claims.

A representative of the company that applied for the glucosamine claims says his company now anticipates a loss in product sales, and complains that it had “invested quite heavily in this submission, in terms of effort and financial outlay.”

Too bad.

Why can’t they come up with the science to support those claims? For one thing, who would want to do the research?  Danone and Yakult have just announced two $50,000 grants to study probiotics.  This won’t go far and the sponsorship is an almost certain guarantee that the results will be just what the companies paid for.

Independent research is much more complicated.  Consider folic acid, for example.  The latest clinical trial of folic acid and colon cancer went to a lot of trouble to prove that folic acid supplements are harmless.  In most people, they have no effect on colon cancer, neither benefit nor risk.  Among the few people who had unusually low levels of the vitamin in their blood, the supplements appeared to have some protective effect.  You can interpret results like this either as evidence for no benefit or as evidence that folic acid supplements might benefit some people under some circumstances.

And that brings us to supplements again.  A trade association for supplement manufacturers says:

While it cannot be denied the food and supplement industry has entertained its fair share of cowboys, our concern is that the [EFSA] regulation goes so far as to throw the baby out with the bathwater. At the very point in time when consumers need most information to help them make the right food and supplement choices to help them offset largely preventable chronic diseases, we see the industry being gagged.

“Cowboys” are indeed a problem, and one well known to the American supplement industry. Says the head of the Council for Responsible Nutrition, the euphemistically named supplement trade association:

Fifteen years ago, our biggest threat was an over-reaching FDA….More recently, the problem has been an FDA that’s under funded and lacks the political will to do what it needs to do. And as a result today, many of the problems that burden the dietary supplement industry are ones that come from within the industry itself from that lack of oversight….Companies… intentionally – or inadvertently – put prescription drugs or anabolic steroids into their products and call them dietary supplements; products that just don’t do what they claim.  Also some companies practice economically motivated adulteration, passing off shoddy products as something more than they are … and ignore the new GMP requirements in hopes that they will fall under the radar screen.

Perhaps in response, the Boston Globe says we should repeal the 1994 law that deregulated dietary supplements and give the FDA some regulatory teeth.  Good idea.

Please forgive my endless repetition of this mantra: health claims are about marketing, not health.

Sep 30 2009

Distress in the supplement industry

Ah those British.  So ahead of us in so many ways.  A professor in Aberdeen had the nerve to suggest that supplements don’t make healthy people healthier.  The industry reacted accordingly. More interesting is the expectation that sales of vitamin and mineral supplements are expected to drop by 50% in the near future.  Imagine: the British don’t think they do much good.

But maybe Americans don’t either?  The September issue of Nutrition Business Journal (NBJ) is full of doom and gloom.  The FDA wants to regulate supplements.  Congress is rethinking the Dietary Supplement Health and Education Act of 1994 (DSHEA) – the one that deregulated the industry.  Today’s New York Times discusses congressional hearings about problems with sports supplements that contain steroids but don’t say so.

So maybe DSHEA wasn’t such a great idea.  Sports supplements and those for weight loss are getting bad press for the harm they cause.   Coupled with the economic downturn, none of this is helping sales.  NBJ says last year’s 5% growth in supplement sales is the lowest since 1997 and predicts that next year will be worse.

Why?  As NBJ explains, it gets letters from doctors saying things like this: “I’ve become stronger in my conviction that taking supplements is nothing more than a giant crapshoot.”

This, I argue, is the entirely predictable result of deregulation.  The supplement industry worked relentlessly to get itself deregulated.  It even wrote the language of the bill that Congress eventually passed (I describe this history in detail in Food Politics).  This industry is now facing the consequences of its own actions.

How ironic that supplement makers will be begging the FDA for regulation if for no other reason than to gain some trust.

Jul 25 2009

No wonder athletes take supplements: testosterone!

I’m not usually an avid reader of the sports pages but a recent article in the New York Times caught my eye.  A couple of over-the-counter dietary supplements adored by high school football players – Tren Xtreme and Mass Xtreme (manufactured by American Cellular Labs) – turn out to contain “designer” (translation: artificially synthesized) testosterone.

Why do high school athletes take this stuff?  Obviously, because it works. Never mind the effects of excess testosterone on bone growth in adolescent boys (not good).

The article sheds considerable light on the murky business of selling such products, the use of illicit drugs in sports, the wink-wink attitudes of everyone involved, and the difficulties faced by federal regulators.

Add this to the reasons why we need Congress to allow real regulation of dietary supplements.

Jun 17 2009

Pesky problems with multi-nutrient supplements

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.

May 14 2009

Will the FDA start regulating supplements?

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?

Apr 16 2009

Europe demands scientific support for health claims. Why can’t we?

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.

Apr 14 2009

Choosing foods: salads, French fries, and supplements

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).