by Marion Nestle

Currently browsing posts about: Supplements

May 29 2012

The latest battle in the supplement wars: FDA v. DMAA

Welcome to the largely unregulated universe of dietary supplement marketing, in this case of DMAA, a.k.a. 1,3-dimethylamylamine, methylhexanamine, or geranium extract (from which it is supposedly isolated).
DMAA is supposed to stimulate athletic performance.
In April, the FDA sent letters warning ten DMAA distributors that it considered their products adulterated because:
  • DMAA does not naturally come from a food.
  • Most of it is produced synthetically
  • It might not be safe.
The FDA received 42 complaints of adverse events associated with taking DMAA supplements.  Although the reports do not prove that DMAA caused the problems, these are serious: cardiac disorders, nervous system disorders, psychiatric disorders, and death.The FDA says:

dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).

One FDA warning letter went to a company called Muscle Warfare for its DMAA supplement “Napalm” which “produces intense sensations of power, drive, energy, focus, motivation, and awareness.  Enormous strength, speed and endurance increases may result.”

Here’s how the company says Napalm works:

Upon ingestion, energy is almost instantly kicked in with Air Strike while core body heat is dramatically supported. This extra body heat may then dramatically support the release of heat shock proteins, during your workout by way of our patent pending Thermobraic Heat Shock Protein Deployment System via Myobolic-SERMS/1&2….Muscle Pumps are fueled via a remarkable creatine free, Plasma Scorch Muscle Engorgement Agent….

Just pure power and dry hard size. Anabolism is kicked in by your ultra-intense workout coupled with our powerful mTOR pathways inducing Vaso-Anabolic Branched Chain Amino Acid Blend. Further hormonal anabolic support is induced by our patent pending NMDA™ hormonal support agent. NMDA™ specifically targets growth hormone, testosterone, IGF-1 and IGF-2 release and has been scientifically shown to provide dramatic support!

As I keep saying, you can’t make this stuff up.

The supplement industry, ever eager to find an athletic supplement that everyone will want to take has reacted with outrage to the FDA’s warning letters (see NutraIntredients-USA.com for a series of articles on DMAA).

Since Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, the supplement industry has gotten a virtually free pass on regulation and its less scrupulous members push the limits of marketing to the point where the FDA has no choice but to act.

DMAA supplement marketers now argue that if DMAA comes from geraniums, synthetic DMAA should be legal. 

I had no idea people were eating geraniums, but never mind.  The flowers may not contain DMAA anyway.

According to NutraIngredients, most DMAA is synthetic (hence: not natural):

There is only one study repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85) – which analytical testing experts contacted by NutraIngredients-USA say is “not scientifically defensible“.

The supplement industry views the warning letters as signs that the FDA is going to start giving its products greater scrutiny.

That would be a step in the right direction, but maybe the FDA won’t have to.  The warning letters elicited a flood of  class action lawsuits against DMAA.

If the FDA won’t or can’t act, lawyers will take up the burden of regulating potentially unsafe and misleadingly marketed supplements.

Update, June 29:  Oops.  Investigators fail to find DMAA in geranium extracts or oils. 

Apr 10 2012

Nutritionist’s Notebook: Caffeine Cravings

On Tuesdays, I answer questions about nutrition in NYU’s student newspaper, the Washington Square News.   These appear intermittently on the newspaper’s website.  Today’s is about caffeine.

Question: What kind of effect does caffeine have on our metabolism and general health? What is an appropriate amount of caffeine to have? And are certain sources of caffeine better than others? 

Answer: Caffeine is a mild upper. It perks up your central nervous system and makes you feel more alert, energetic and cheery. Caffeine is common in plants, but coffee, chocolate and tea have the most. The amount of caffeine depends on the type, amount used and brewing time, from 30 milligrams for a small cup of weak tea to more than 300 milligrams for some of the larger and stronger Starbucks drinks. When caffeine appears on the labels, you know exactly how much you are getting.

Energy drinks made for adults, like Red Bull, contain about 80 milligrams in an eight-ounce can. Coca-Cola, Pepsi-Cola and other soft drinks marketed to children have much less — 30 to 40 milligrams in 12 ounces.

People react to caffeine in different ways and, by this stage in your life, you undoubtedly know how much of it you can handle and at what time of the day you can handle it. If you take in more than your personal limit, you may feel nervous, shaky and sleepless. The more caffeine you drink, the more you become accustomed to it and the harder it is to give up. Some researchers think that the mix of sugar with caffeine is what makes some people feel addicted to soft drinks.

Perhaps it’s the caffeine in coffee that makes researchers want to find something wrong with it. I have a thick file of papers claiming that coffee raises the risk for heartburn, cancer, heart disease, infertility, ulcers and many other health problems, but the observed effects are small, inconsistent and unconvincing. When given as a drug, caffeine stimulates urine production and suppresses appetite, but the amounts in all but the strongest coffees are too low to produce such effects. If you get shaky when you drink caffeinated beverages, it’s time to stop.

—A version of this article appeared in the Tuesday, April 10 print edition. Marion Nestle is a contributing columnist. Email her questions at dining@nyunews.com.

Additional note on the food politics of caffeineSenatorDick Durbin (Dem-IL) has just asked the FDA to enforce its own rules on drink labeling.  Some makers of high-caffeine “sports” drinks are marketing them as dietary supplements to avoid having to adhere to FDA rules on how much can go into soft drinks.

Nov 30 2011

Report from the EU: functional foods, supplements, health claims


Sebastián Romero Melchor writing in Food Chemical News (subscription required, alas) a few days ago points out that the market for functional foods in the European Union is growing.  He advises U.S. firms who want to take advantage of  its €40 billion (equal to roughly $54 billion USD) market to pay attention to some important facts:

  • Novel ingredients: Ingredients that were not consumed to a significant extent in the EU before May 15, 1997 must undergo a costly and lengthy authorization procedure so dreadful that most companies give up and choose not to include them.
  • Supplements: The European Commission has no problem with vitamins and minerals, but marketing of food supplements and fortified foods remains subject to each European country’s separate national laws.  Products legally marketed and/or manufactured in a member-state can be legally marketed throughout the EU, provided that they are (a) safe, (b) not novel, and (3) not medicinal.
  • Health claims: The European Food Safety Authority (EFSA) has issued opinions on health claims for most substances.  It has evaluted about 2,750 petitions for health claims but only approved about 600.

If only the FDA would take as rigorous a stance.

Oct 13 2011

Alas, vitamin supplements

Two studies released this week provide additional evidence that vitamin supplements are potentially harmful and, at the very least, do no good.

This depressing news comes from the Iowa Women’s Health Study.  Older women in the study who took supplements ranging from multivitamins to high doses of single nutrients had a greater risk of dying than those who did not.

Equally depressing are the results of a trial of high-dose vitamin E and selenium versus prostate cancer.  It found higher rates of the cancer among men taking vitamin E (selenium was somewhat protective).   In this trial, it was so obvious that the supplements did not protect against prostate cancer that the investigators ended it before its scheduled date of completion.

USA Today interviewed me and Dr. Jeffrey Blumberg (Tufts University) about our interpretations of these trials.

I think that the main conclusion to be drawn from this research is that supplements do not make healthy people healthier.   They may not cause harm at high doses, but they appear not to do good.

I don’t take them and I don’t recommend them—except to people who have diagnosed nutrient deficiencies or other problems handling nutrients.

Dr. Blumberg, in contrast, thinks multivitamins constitute a useful nutrition insurance policy and everybody should be taking them.

Supplements are a good example of how scientists can interpret research in different ways, depending on point of view.  I illustrate this point in Food Politics in a table in which I compare what I call “belief-based” (for lack of a better term) and “science-based” approaches to deciding whether supplements are needed, effective, or safe (see table 29, page 232).

For example, on the need for supplements, a belief-based approach rests on:

  • Diets do not always follow dietary recommendations.
  • Foods grown on depleted soils lack essential nutrients.
  • Pollution and stressful living conditions increase nutrient requirements.
  • Cooking destroys essential nutrients.
  • Nutrient-related physiological functions decline with age.

A science-based approach considers:

  • Food is sufficient to meet nutrient needs.
  • Foods provide nutrients and other valuable substances not present in supplements.
  • People who take supplements are better educated and wealthier: they are healthier whether or not they take supplements.

The statements in both approaches are true.

This is why point of view is such an important consideration in interpretation of nutrition research.

May 15 2011

Foods with benefits? Oh, please.

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.

Dec 15 2010

FTC goes after kids’ vitamin claims (yogurt, too!)

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!


Aug 9 2010

Supplements in trouble—again!

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!

May 28 2010

Dismal reports on dietary supplements

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.