Currently browsing posts about: Supplements

Sunday’s New York Times has not one but two articles about “functional foods,” those with something added over and above what’s in the food in the first place.

A front-page story, “Dessert, laid-back and legal,” describes brownies.  No, not brownies laced with marijuana.  This time they contain the sleep-inducing drug melatonin.

The brownies, according to the Times, contain just as much melatonin as are found in drug pills but are cheaper and can be purchased with food stamps (another reason for taking a look at the whole question of SNAP benefits?).

Since melatonin is a drug and not an approved food additive, the makers of these products are trying to get around the annoying FDA restrictions by marketing the brownies as “dietary supplements.”  Supplements, by order of Congress when it passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, do not have to meet FDA’s rigorous scientific criteria for safety or efficacy.

DSHEA applied to supplements, not foods, but the FDA has chosen to regulate foods containing such additives by the weaker rules applying to supplements and to deal with them as a regulatory gray area.   Is melatonin a drug, a supplement, or in brownie from a food?  The FDA is going to have to decide this, and fast.

A much longer story in the business section, “Foods with benefits, or so they say” (in which I am quoted) focuses on the entire point of functional foods: the ability to put something in a product that allows you to market it using health and wellness claims.  Health claims sell food products.  People like buying products with a “health aura,” no matter how poorly the health claim is supported by science.  Science is irrelevant here.  Marketing is what’s relevant.

As I discuss in my book, Food Politics, until the early 1990s, the FDA did not allow health claims on food products.  Claiming a specific health benefit for a food, said the FDA, meant that the food was being marketed as a drug.  If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

When Congress passed the Nutrition Labeling and Education Act in 1990, it struck a deal with the food industry.  The industry was objecting that because Nutrition Facts labels required them to say what was bad about their products, they ought to be allowed to say what was good about them.  Congress agreed, and forced the FDA to review the science linking certain food ingredients to health benefits as a basis for permitting health claims.

The FDA approved some claims but rejected others.  The rejected companies took the FDA to court, and the courts mostly ruled in favor of the companies on the grounds of the First Amendment.  The FDA stopped trying to control unsupported health claims and only recently has taken then on again.

But as sales soar, federal regulators worry that some packaged foods that scream healthy on their labels are in fact no healthier than many ordinary brands. Federal Trade Commission officials have been cracking down on products that, in their view, make dubious or exaggerated claims. Overwhelmed regulators concede that they are struggling to police this booming market, despite recent settlements with makers of brands like Kellogg’s Rice Krispies and Dannon’s Activia, which the authorities say oversold their health benefits.

To the distress of international food marketers, the U.S. currently has much looser regulations about health claims than are available in Europe.  The European Food Safety Authority has been reviewing thousands of petitions for health claims on food products and turning most of them down as scientifically unsubstantiated.  That doesn’t stop American food makers from loading on the claims.

From the ivory tower in which I sit, the remedy is easy: don’t allow health claims on processed foods at all.  The claims are all inherently misleading, as would be obvious if you gave it a minute’s thought.

But if they aren’t worth much to you, they are worth plenty to the marketers of processed foods.  And that’s what this is really about.

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!

You have to pity the poor supplement industry.  It is taking a real beating these days.

First, the Government Accountability Office told a Senate committee that the dietary supplement industry routinely uses “questionable and deceptive” marketing practices and gives potentially dangerous advice.

USA Today agreed.  In an editorial, it noted that:

Industry spokesmen have gotten away for years with minimizing all this as just the work of a handful of bad apples. Lobbyists say responsible makers and distributors should not be burdened with more government oversight. But the problem is big enough that another GAO study last year found nearly 1,000 reports in a 10-month period of specific health problems linked to supplements, including nine deaths, 64 life-threatening illnesses and 234 hospitalizations. Nobody knows how many other incidents never got reported.

In defense, an industry spokesman blamed the FDA:

As FDA Deputy Commissioner Joshua Sharfstein acknowledged last week, DSHEA strikes the right balance, but FDA needs to do more to maintain that equilibrium. FDA must use the tools it was given under the law to address the issues that hurt the credibility of responsible companies and undermine consumer confidence.

And now, the September issue of Consumer Reports list the “Dirty Dozen” supplements that research links to nasty problems such as cancer, coma, heart problems, kidney damage, liver damage, or death: aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe.  The FDA has been warning about the ones shown in red for years.  But these and the others are still on the market.

Among other suggestions, Consumer Reports advises:

Beware of these categories. Supplements for weight loss, sexual enhancement, and bodybuilding have been problematic, the FDA said, because some contain steroids and prescription drugs.

Don’t assume more is better. It’s possible to overdose even on beneficial vitamins and minerals. Avoid any product that claims to contain “megadoses.”

Report problems. Let your doctor know if you experience any symptoms after you start taking a supplement…do it yourself at www.fda.gov/medwatch or by calling 800-332-1088.

Research in the right places. Be skeptical about claims made for supplements in ads, on TV and by sales staff. If a claim sounds too good to be true, it probably is.

Consumer Reports provides online links for assessing supplements at www.ConsumerReportsHealth.org.

Yes, I know half the U.S. adult population takes supplements and nearly everyone who takes them claims to feel better as a result.  The science, however, consistently produces reasons for skepticism, if not caution.

I discuss this discrepancy in Food Politics. Take a look and decide for yourself!

Dietary supplements are in trouble these days.  For one thing, it’s really hard to demonstrate that they do any good.  For another, these products are poorly regulated.  Some recent examples:

• Gingko biloba supplements don’t improve cognitive function in the elderly.
• St. Johns Wort supplements don’t improve irritable bowel syndrome.
• Most supplements do not improve mortality, except maybe glucosamine and chondroitin sulfate which are associated with a slight unexplained improvement in this particular review.
• Most supplements are contaminated with toxic heavy metals says a GAO report with one of this agency’s typically inimitable titles: Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Questionable Advice.

The New York Times account of the GAO report quotes Steve Mister, president of the Council for Responsible Nutrition, the supplement industry trade association, unsurprised by this finding.  Heavy metals, he said, are routinely found in soil and plants: “I don’t think this should be of concern to consumers.”

Oh great.  Glad he thinks so.  I’d be happier if we had a bit more regulation of these products.

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.

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.

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.