Currently browsing posts about: Supplements

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.

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.

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: