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It’s not a good time for the makers of herbal and vitamin supplements.  The better the research, the fewer benefits it shows.

Herbal supplements

DNA testing is demonstrating what many of us have long suspected: herbal supplements are not necessarily what they say they are.

As the New York Times reports, a recent study shows that many products purporting to be herbal supplements, actually contain rice, corn, or wheat (gluten-sensitive folks beware):

I would feel sorry for supplement manufacturers, if they hadn’t brought this on themselves.

First, they lobbied to get Congress to pass the Dietary Supplement Health and Education Act of 1994 (DSHEA).  This lets them advertise the benefits of supplements without much in the way of scientific substantiation.  It also excused the FDA from doing much regulation.

But DSHEA also required research.  Oops.   Although the point of asking for research was to demonstrate the benefits of supplements, things haven’t worked out that way.  Most of the research shows no benefit and, sometimes, harm.

And investigations like this one show what many have long suspected.  Without federal oversight, some supplement manufacturers will do whatever they can get away with.

Fortunately, rice substituted for St. John’s Wort is harmless and hardly matters, since St. John’s Wort doesn’t seem to do much anyway.

Vitamin Supplements

The latest review of the benefits—or lack thereof—of vitamin supplements for prevention of heart disease or cancer comes to cautious conclusions.

Limited evidence supports any benefit from vitamin and mineral supplementation for the prevention of cancer or CVD. Two trials found a small, borderline-significant benefit from multivitamin supplements on cancer in men only and no effect on CVD.

Borderline significance?  Not impressive.

The Natural Products Association, which represents supplement makers, issued a response:

• Multivitamin supplements should not be expected, without the combination of a healthy lifestyle, to prevent chronic disease.
• Dietary supplements are used by more than 150 million Americans on a daily basis. Research has shown that when taken in combination with other healthy lifestyle practices, such as consuming a wholesome diet and exercising regularly, people can benefit from dietary supplements.

Translation: if you consume a wholesome diet and exercise regularly, you really don’t need supplements.  And if you are not doing those things, supplements won’t do any good.

As for the 150 million Americans who take supplements: the ones I know tell me that they don’t care what the science says; they feel better when they take the pills.

Let’s hear it for placebo effects!

The FDA has sent a warning letter to a supplement manufacturer, Europharma, to cease and desist making health claims for several of its products.  The company, says the FDA, is promoting these products

for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act…because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

What’s interesting about this is that the focus is on what the articles say, not what is stated on the website.  This is a new approach for FDA and it will be interesting to see if it works.

According to FoodNavigator.com, Europharma is filing objections, is not admitting wrongdoing, but has removed links to the offending literature from its website.

Progress?

The bad news about dietary supplements pours in.  Most of them are harmless, but this industry is largely unregulated and the lack of oversight shows.

Here’s a brief summary of recent reports and an old one I’ve been saving for an occasion like this:

Some supplements do more harm than good

     A lengthy investigative report in the New York Times describes the death of a 22-year-old Army private attributed to taking a recommended dose of a workout supplement, Jack3d, bought at a GNC store on the base.

Jack3d contains a powerful stimulant called dimethylamylamine, or DMAA for short, which has similar effects as amphetamines, but claims to produce “ultra-intense muscle-gorging strength, energy, power and endurance.”

Some supplement companies don’t report problems to FDA

The Government Accountability Office (GAO), in Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products, reports a doubling of the number of adverse event complaints to the FDA since 2008.  It attributes the increase to FDA’s enforcement efforts and to lawsuits publicizing situations in which supplement firms are not reporting problems.

Some supplement companies can’t back up health claims

Last year, the Department of Health and Human Services’ Office of Inspector General (OIG) issued two reports examining health claims on immune support and weight loss supplements, both fast-growing segments of the industry.

In its first report, Structure/Function Claims Fail To Meet Federal Requirements, the OIG points to FDA’s limited enforcement authority over such claims.  As a result, supplement companies cut corners and ignore requirements for such claims.

Some supplement companies make it hard to complain

In its second report, Dietary Supplements: Companies May Be Difficult To Locate in an Emergency, OIG says that many supplements do not put information about where to file adverse event reports on their labels.   Many companies fail to register with the FDA.  And when companies do register, they neglect to provide required information.  About 20% of dietary supplement labels dd not provide telephone numbers or addresses where consumers can report adverse events.

The supplement industry brought this on itself

A year or so ago, the New York Times published a long article about the cozy relationship between Senator Orrin Hatch (Rep-Utah) and the supplement industry.

If you want to understand how the supplement industry gets away with ignoring regulations, read how “Senator Orrin G. Hatch has helped the nutritional supplement industry, and been rewarded with donations.”

He was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable.

When Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, it effectively deregulated the industry, allowing it to use a new category of vague health claims (“structure-function”), to use Supplement Facts labels, and to escape much in the way of oversight.

Even if we assume that most supplement manufacturers are honest about what’s in their products and what the products can and cannot do, some are not.  DSHEA gave the less honest manufacturers plenty of room to cause trouble, and so they do.

We will be seeing more such reports, no doubt.

Malden Nesheim and I wrote an editorial for the Annals of Internal Medicine that has just gone online, and is likely to elicit plenty of discussion.  We comment on the highly conservative, evidence-based recommendations of the U.S. Preventive Services Task Force for taking supplements of calcium and vitamin D as a means to prevent osteoporosis.

Our commentary: “To Supplement or Not to Supplement: U.S. Preventive Services Task Force Recommendations on Calcium and Vitamin D.”  Here’s what we said:

In this issue, the U.S. Preventive Services Task Force (USPSTF) plunges headlong into ongoing debates about whether healthy adults—those who show no signs of vitamin D deficiency or osteoporosis—should be advised to take combined supplements of calcium and vitamin D to prevent bone fractures and, if so, at what level (1).

In terse statements unlikely to settle the debates, the Task Force states first that insufficient evidence makes it impossible to determine how supplementation affects fracture incidence in men or premenopausal women. Next, it deals with postmenopausal women. For this group, the Task Force says that evidence is insufficient to assess the effects of daily supplementation with greater than 400 IU of vitamin D₃ and greater than 1000 mg of calcium. The Task Force’s unambiguous conclusion: Supplementation at or below those levels does not prevent fractures. Because supplementation at or below 400 IU of vitamin D₃ and 1000 mg of calcium seems to convey a slightly increased risk for renal stones, the USPSTF recommendation for postmenopausal women is also unambiguous: “do not supplement.”

The Task Force based these decisions on 2 commissioned evidence reviews and a meta-analysis  (2 – 4). More recent data from the Women’s Health Initiative also are consistent with inconclusive findings, except among a subgroup of long-adherent supplement recipients who experienced a reduced risk for hip—but not total—fractures (5).

The Task Force’s recommendations must be interpreted in the light of ongoing disputes about the most effective method for assessing vitamin D deficiency, whether calcium and vitamin D supplements are needed by a large portion of the population, and what level of supplementation might best maximize benefits and minimize risks.

In 2011, after reviewing more than 1000 studies, the Institute of Medicine (IOM) concluded that vitamin D and calcium are indeed critical to bone health but their role in other diseases—cancer, heart disease, diabetes, immune function, and reproductive health, for example—remains uncertain. The IOM did not consider deficiencies of either calcium or vitamin D to be serious problems in the United States, except among certain population groups. Instead, because of widespread fortification and supplementation, the IOM was concerned about the possibility of adverse consequences from oversupplementation (6).

With risks as well as benefits in mind, the IOM established the average adult daily requirement for calcium at 800 to 1000 mg depending on age, the Recommended Dietary Allowance (the amount needed to meet the needs of about 97% of the population) at 1000 to 1200 mg, and the safe upper level of intake at 2000 to 2500 mg. Its corresponding recommendations for vitamin D were 400 IU, 600 IU (800 IU for older adults), and 4000 IU, respectively. The IOM viewed these levels as sufficient to maintain blood levels of 25-hydroxyvitamin D at or above 20 ng/mL, a level it considered adequate to meet population-based needs regardless of amounts synthesized as a result of sun exposure.

Vitamin D, of course, is not a vitamin in the usual sense. It is a hormone produced in response to the action of sunlight on skin. Like other hormones, vitamin D has multiple roles in the body, not all of them well-understood. Vitamin D supplementation, therefore, must be considered a form of hormone replacement therapy. As such, it raises all of the questions about efficacy, dose, and side effects currently asked of such therapies.

In that light, the 2011 recommendations of the Endocrine Society deserve special scrutiny (7). The Society approaches questions about vitamin D from a standpoint quite different from that of the IOM. It appointed its own task force to make recommendations based on the premise that vitamin D deficiencies are common among all age groups. The Society prefers 30 ng/mL of 25-hydroxyvitamin D as the target level for maximum benefits. By that criterion, virtually all U.S., Canadian, and European adults are deficient in hormone vitamin D and require daily supplements of 1500 to 2000 IU. For adults with demonstrated deficiency, the Society recommends treatment with 50 000 IU of the hormone once a week or daily supplementation of 6000 IU for 8 weeks, followed by 1500 to 2000 IU for maintenance.

This clinical endocrinology perspective differs from the nutrition science perspective of the IOM committee, whose members tend to interpret studies of single nutrients within the context of the diet as a whole. From this standpoint, the amount of hormone generated by the action of sunlight on skin (which ought to be more than adequate for people who spend time outdoors in latitudes as far north as Boston) is crucial to decisions about supplementation. The IOM and Endocrine Society debated their conflicting perspectives in an exchange published in 2012 (8 – 9). The insufficiency of research to resolve such arguments has permitted vitamin D to become “trendy.” It is advertised on boxes of fortified cereals, has its own prosupplement advocacy group, and generates millions in annual supplement sales (10).

The USPSTF’s recommendations can be understood as an attempt to clarify the present situation with respect to one specific outcome of supplementation. In doing so, its recommendations have a substantial advantage. They depend on hard end points—fractures—rather than on blood levels of 25-hydroxyvitamin D, at best an indirect measure of vitamin D adequacy. The USPSTF uses the same precautionary approach as did the IOM. In the absence of compelling evidence for benefit, taking supplements is not worth any risk, however small.

A previous attempt to sort through the various claims for vitamin D noted an urgent need for further research to answer fundamental questions about the risks and benefits of sun exposure, fortification, and supplements, and the hormone’s role in body functions beyond bone mineralization (11). The USPSTF plans to publish further recommendations on the role of vitamin D in cancer prevention. When it does, we hope it will keep in mind the value of making a single recommendation about vitamin D and calcium supplementation that will encompass all potential benefits and risks. Multiple recommendations by condition confuse practitioners and the public. While we wait for the results of further research, the USPSTF’s cautious, evidence-based advice should encourage clinicians to think carefully before advising calcium and vitamin D supplementation for healthy individuals.

References

1  Moyer VA; U.S. Preventive Services Task Force.  Vitamin D and calcium supplementation to prevent fractures in adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013. [Epub ahead of print]

2  Cranney A, Horsley T, O’Donnell S, Weiler H, Puil L, Ooi D, et al.  Effectiveness and safety of vitamin D in relation to bone health. Evid Rep Technol Assess (Full Rep). 2007:1-235. [PMID: 18088161]

3 Chung M, Balk EM, Brendel M, Ip S, Lau J, Lee J, et al.  Vitamin D and calcium: a systematic review of health outcomes. Evid Rep Technol Assess (Full Rep). 2009:1-420. [PMID: 20629479]

4 Chung M, Lee J, Terasawa T, Lau J, Trikalinos TA.  Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155:827-38. [PMID: 22184690]

5 Prentice RL, Pettinger MB, Jackson RD, Wactawski-Wende J, Lacroix AZ, Anderson GL, et al.  Health risks and benefits from calcium and vitamin D supplementation: Women’s Health Initiative clinical trial and cohort study. Osteoporos Int. 2013;24:567-80. [PMID: 23208074]

6 Institute of Medicine.  Dietary Reference Intakes: Calcium, Vitamin D. Washington, DC: National Academies Pr; 2011.

7 Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, et al; Endocrine Society.  Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1911-30. [PMID: 21646368]

8 Rosen CJ, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, et al.  IOM committee members respond to Endocrine Society vitamin D guideline. J Clin Endocrinol Metab. 2012;97:1146-52. [PMID: 22442278]

9 Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, et al.  Guidelines for preventing and treating vitamin D deficiency and insufficiency revisited. J Clin Endocrinol Metab. 2012;97:1153-8. [PMID: 22442274]

10 Supplements stand out as 2008 sales bright spot for U.S. nutrition industry. Vitamins: D still shines. Nutrition Business Journal. 2009;14(6/7):5. Accessed athttp://newhope360.com/research-and-insights/supplements-stand-out-2008-sales-bright-spot-us-nutrition-industry on 15 February 2013.

11 Brannon PM, Yetley EA, Bailey RL, Picciano MF.  Overview of the conference “Vitamin D and Health in the 21st Century: an Update”. Am J Clin Nutr. 2008;88:483S-490S. [PMID: 18689388]  

Here’s the first objection:

• From the Natural Products Association

NutraIngredients.com reports frequently on current research and opinion on dietary supplements.  Lots of people take these products and swear by them, but proving that they do much good is another matter.  It has been hard to find evidence that they make healthy people—those who take them most often—any healthier.

Here are some recent NutraIngredient reports on this topic, largely reflecting views of the supplement industry.

• Multivitamins: ‘The cheapest health insurance a person will ever buy
• Multivitamin supplements may cut cancer risk: JAMA paper
• Multivitamin Study: Making Lemons Out of Lemonade
• Multivitamins may not benefit heart disease risk, but ‘don’t forget the aim and other potential benefits of supplements’
• U.S. supplement use remains strong, CRN survey says
• Vitamin Shoppe: US supplement user confidence soars to 93% as usage increases
• Multivitamin Supplements Boost Brain Function, say U.K. Researchers
• Looking forward: The emerging evidence for vitamins and health
• Global population demands, ‘confusing’ media coverage and the 100 year old vitamin [Vitamin A]
• Multivitamins – They Won’t Wash the Windows or Change the Oil Either!
• Multivitamins may not benefit heart disease risk, but ‘don’t forget the aim and other potential benefits of supplements

According to a new study in JAMA, multivitamins might reduce the risk of some cancers, although not by much.

But even a tiny benefit, restricted to skin cancers in healthy male doctors—but not prostate cancers, alas—is good news for the supplement industry.  Supplement sellers are eager to make sure you don’t miss this research.

The study results came out on October 18.  Pfizer, the maker of the Centrum Silver pills used in the study, placed this ad in the New York Times on October 19:

But that’s not all.  CVS pharmacy sent me this personal e-mail message:

Pfizer, of course, could not be happier.

Why do I think this is about marketing, not public health?

• DMAA does not naturally come from a food.
• Most of it is produced synthetically
• It might not be safe.

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 caffeine:  SenatorDick 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.