Currently browsing posts about: Supplements

Skeptic of the value of dietary supplements that I am, I cannot help feeling sorry for Herbalife.

The company sells protein shakes and snacks, vitamins and dietary supplements, and energy and fitness drinks which, it says, “combined with healthy eating and exercise, can help you lead a healthy, active life.”

Yes indeed, healthy eating and exercise will do that for you every time.

But Herbalife has become the victim of a bizarre hedge fund bet and its consequences.

In what is one of the most blatant conflicts of interest besetting a food product, a hedge fund manager, William Ackman, made a billion dollar “short” bet that Herbalife’s stock would fall.

When the stock did not do so immediately, Mr. Ackman set out to destroy the company’s reputation to force its stock down.

He even got members of Congress, including Senator Edward Markey (Dem-Massachusetts) to call for an investigation of the company’s marketing practices, an action that caused a 14-point drop in the stock.

This decidedly unsavory story was the subject of a New York Times investigative report yesterday: “Staking $1 Billion That Herbalife Will Fail, Then Lobbying to Bring It Down.”

The company has grown into a global powerhouse, with a worldwide team of more than three million so-called members and distributors who operate as independent contractors through a system that rewards many of them not only based on actual sales, but also on their ability to recruit more distributors.

The sales tactic, popular with many nutritional supplement companies, has frequently been the target of criticism. In 1986, California authorities issued an order prohibiting Herbalife from making false claims about the weight-loss powers of its nutritional drinks.

Herbalife reported sales of $4 billion in 2012 and is sold in more than 90 countries by distributors who earn profits on product sales and additional commissions from a “multi-level marketing” compensation structure.

Ackman argues that this is a pyramid scheme that particularly disadvantages Hispanic distributors and customers.  Other hedge funds disagree and have placed “long” bets on Herbalife.

This is food politics at a breathtaking level of income.  The Times story is well worth a look.

I love this new graphic from the Council for Responsible Nutrition, the trade association for the dietary supplement industry.

My favorite: “Supplement consumers are more likely to engage in other healthy habits than non-consumers.”

This is delightfully ambiguous.  Does it mean: Supplements make consumers healthier?

Or does it mean: consumers who are healthy to begin with are the ones who take supplements?

I vote for the latter.  That’s why the great majority of studies of supplements and health show no effect.  Study subjects are already healthy and don’t need them.

By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods, energy shots, for example.

Under the law, the FDA pretty much has to keep hands off of supplements, except when something egregious happens, like people getting sick or dying.

The FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs.  It just issued:

• Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages
• Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages

These documents, however, are guidance.  The are not regulations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Why is FDA doing this?  I’m guessing for two reasons.

1.  The weird ingredients in energy drinks:

We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods. 

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.

2.  The high caffeine levels in those drinks.

Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks.

But the levels in energy drinks are so much higher that the FDA has questions about whether GRAS applies to them.

These guidance documents are open for comment.  If you care about such issues, weigh in now.

Over the weekend, the New York Times carried a front-page story about liver damage caused by an herbal supplement advertised as a “fat burner.”

It pointed out that as a result of a 1994 act of Congress, such products are virtually unregulated.  No federal agency pays much attention to their contents or claims, and Congress only lets the FDA take action against them after they are found to be harmful.

Fortunately, vitamin and mineral supplements rarely cause harm.  But the question of whether they do any good continues to trouble researchers.   As NutraIngredients_USA summarizes the latest rounds of research,

Stop wasting money on supplements, say physicians. Stop trying to position supplements as cures for disease, say industry groups.  An editorial panel of medical doctors (MDs) says the case is now closed for multivitamins: they don’t help well-nourished adults. But leading trade associations have defended the safety and efficacy of the products, calling the editorial, ‘close-minded, ‘one-sided’ and ‘overblown.’

The article refers to studies published in a recent issue of the Annals of Internal Medicine.  These showed that multivitamin supplements did nothing to prevent heart attacks or cancer, or improve cognitive function.

• Oral High-Dose Multivitamins and Minerals After Myocardial Infarction:A Randomized Trial
• Long-Term Multivitamin Supplementation and Cognitive Function in Men: A Randomized Trial
• Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force

This led to an editorial entitled:

• Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements

Its conclusion: Most multivitamin supplements do no good; some may do harm.  If you are healthy, you don’t need them.

Not that this will stop anyone from taking them….

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