Currently browsing posts about: Vitamin D

Food Navigator—USA’s Elaine Watson just put together a special edition on the revamping of the Nutrition Facts label.  Her title: Radical overhaul or a missed opportunity?

To understand what’s happening with food labels, you can start with the FDA’s home page on its proposed revisions.  The comment period has ended.  You can read the comments that have been filed on the Nutrition and Supplement Facts panels, and those filed on the proposed changes to the standards for serving sizes.  These are fun to read; opinions, to say the least, vary.

But back to Food Navigator, which collects in various pieces on the topic in one place.  The “Radical overhaul” piece contains a summary of the major provisions.  Others in the series are also useful (I’m quoted in some of them):

Does vitamin D belong on the Nutrition Facts panel?

FDA proposals to list “added sugars” on the Nutrition Facts panel have already generated heated debate, so it’s perhaps unsurprising that its plan to include vitamin D is proving equally controversial…

Should ‘added sugars’ be listed on the Nutrition Facts panel?

A row is brewing over the merits of including ‘added sugars’ on the Nutrition Facts panel, with critics arguing that our bodies don’t distinguish between ‘naturally occurring’ and ‘added’ sugar – and neither should food labels – and supporters saying it will help consumers identify foods with more empty calories.

 Nutrition Facts overhaul is a missed opportunity for long chain omega-3s EPA and DHA, says GOED

The FDA’s overhaul of the Nutrition Facts panel misses a public health opportunity by prohibiting firms from even highlighting long chain omega-3 fatty acids EPA and DHA on the panel, says GOED.

What are the biggest contributors of added sugars to the US diet?

Check out this analysis of NHANES data to see where our added sugars are coming from plus read new comments about the ‘added sugars’ labeling proposal from Ocean Spray cranberries and others.

Former FDA commissioner: Nutrition Facts overhaul doesn’t go far enough

FDA proposals to overhaul the Nutrition Facts panel on food labels don’t got far enough, says former FDA commissioner David Kessler, M.D.

Behavioral scientists: Changing serving sizes on Nutrition Facts label could have unintended consequences

FDA proposals to change the way serving sizes are calculated to better reflect real-life eating behavior could encourage some people to eat even more unless the wording is changed, says one expert group.

Until phosphorus gets on the USDA’s radar, labeling policy won’t change: NKF

While phosphorus is an essential nutrient found naturally in some foods such as egg yolk and milk, it is increasingly added to packaged foods via a raft of phosphorus additives, and some experts believe it should be listed on the Nutrition Facts panel.

Canada’s proposed Nutrition Label changes emphasize calories, sugar

Health Canada is proposing changes to nutrition labels that would make them easier for consumers to read.

RD: There’s a health continuum for every food; what pillars do you want to stand on?

Rachel Cheatham, RD, founder of nutrition strategy consultancy FoodScape Group, talks food labeling at the IFT show.

Is your product ready for nutrition label changes?

“A 16-ounce drink and a two-ounce bag of potato chips are a single serving. If it’s bigger than that, from 200 to 400%, then you need to declare two columns of information—one for the serving size and one for the whole container.”

Proposed nutrition labels more effective than current labels: survey

Consumers find proposed labels easier to read in less time.

How much do consumers use (and understand) nutrition labels?

New research from the NPD Group is questioning how many US consumers even routinely check nutrition labels anymore.

 FDA’s proposed nutrition label changes emphasize calories, serving sizes

If approved, the new labels would place a bigger emphasis on total calories and update serving sizes, while also drawing attention to added sugars and nutrients such as Vitamin D and potassium.

CRN, NPA submit comments on FDA’s proposed changes to food, supplement labels

Both the Council for Responsible Nutrition and the Natural Products Association have submitted a comments on FDA’s proposed revisions for food and dietary supplement labels.

The FDA’s next step is to deal with the comments and issue final rules.  By when?

Eventually.  Stay tuned.

The FDA is taking comments on label proposals until August 1 (see info at end of post).  Here’s mine on voluntary vitamin D labeling.

July 17, 2014

TO:  FDA

FROM:  Marion Nestle, Professor, New York University

RE:  Proposed revision to Nutrition Facts Panel: VITAMIN D

This is to argue against permitting food companies to voluntarily label added “Vitamin” D on the Nutrition Facts panel.  Doing so will not promote—and may possibly harm–public health.

Rationale

• “Vitamin” D is not a vitamin; it is a hormone synthesized by the action of sunlight on skin.  For this reason alone, it does not belong on the food label.
• Vitamin D fortification must be understood as a form of hormone replacement therapy.   As such, it raises questions about efficacy, dose, and side effects that should be asked about all such therapies.
• Fortification and supplementation provide hormone Vitamin D by the oral route.  This is not physiological.  Active vitamin D is synthesized in the body through a series of reactions that begin with the action of sunlight on skin.  Sunlight on skin produces ample Vitamin D, is regulated to promote synthesis as needed and avoid toxicity, and may lead to synthesis of other useful biological components; the unphysiologic oral route does not produce the same benefits.[i]
• As a hormone, Vitamin D is found naturally in very few foods (e.g., fish); in them, it is present in small amounts.  It is present in most foods as a result of fortification.
• Permitting Vitamin D to be listed on food labels will encourage fortification, undoubtedly of foods that would not otherwise necessarily be recommended.  To cite just one example: Yum Bunny Caramel Milk Spread fortified with vitamin D at 10% of the DV.  This product is half sugars by weight, marketed as “a good source of calcium and vitamin D,” and clearly aimed at children. See: http://www.yumbunny.com/about-us.   Whether such products should be considered “good sources” also deserves scrutiny.
• The U.S. Preventive Services Task Force concludes that evidence is insufficient to determine how Vitamin D supplementation (and, therefore, fortification) affects fracture incidence.[ii]^,[iii],[iv] 
• Data from the Women’s Health Initiative also are consistent with largely inconclusive findings about hormone Vitamin D supplements and bone health.[v]
• The Institute of Medicine (IOM) does not consider deficiency of Vitamin D to be a serious problem in the United States, except among certain population groups.  Instead, because of widespread fortification and supplementation, it is concerned about the possibility of adverse consequences from overconsumption through supplementation or fortification.[vi]
• Many scientific debates about hormone Vitamin D are as yet unresolved.[vii]^,[viii]  
• The lack of compelling research has permitted Vitamin D to become “trendy.”  It is advertised on boxes of fortified cereals, has its own pro-supplement advocacy group, and generates millions in annual supplement sales.[ix]

In the absence of stronger evidence for benefit from fortification, and some evidence for possible adverse consequences, the FDA should not contribute to further commercialization of this misnamed hormone by permitting it to be listed on food labels.

References

[i] Wacker M, Holick MF.  Sunlight and Vitamin D: A global perspective for health. Dermato-Endocrinology 2013;5(1):51–108.

[ii] 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. Evidence Report/Technology Assessment No. 158. Rockville, MD: Agency for Healthcare Research and Quality. 2007.  http://www.ncbi.nlm.nih.gov/books/NBK38410. Accessed February 5, 2013.

[iii] Chung M, Balk EM, Brendel M, Ip S, Lau J, Lee J, et al  Vitamin D and calcium: a systematic review of health outcomes. Evidence Report/Technology Assessment No. 183. Rockville, MD: Agency for Healthcare Research and Quality. 2009.  http://www.ncbi.nlm.nih.gov/books/NBK32603/. Accessed February 5, 2013.

[iv] Chung M, Lee J, Terasawa T, Lau J, Trikalinos T. 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(12):827-38.

[v] 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.  Osteoporosis Int.  2013;24(2):567-580.

[vi] Institute of Medicine.  Dietary Reference Intakes: Calcium, Vitamin D.  Washington, DC: National Academies Press, 2011.

[vii] Rosen, Clifford J,  Abrams, Steven A,  Aloia John F. et al.  IOM Committee members respond to endocrine society vitamin D guideline. J Clin Endocrinol Metab. 2012;97:1146-1152.

[viii] Holick, Michael F,  Brinkley Neil C, Heike, A et al  Guidelines for preventing and treating vitamin D deficiency and insufficiency revisited.  J Clin Endocrinol Metab. 2012;97:1153-1158.

[ix] Much growth in vitamin sales driven by vitamin D.  Nutr Business J. 2009;14(6/7):5.

Here’s how to file comments:

The proposed revisions are to:

• Nutrition and Supplement Facts Labels
• Serving Sizes 

The FDA makes it very easy to file comments. It provides:

• All necessary information in one place.
• A short guide and checklist

File comments here

• Nutrition and Supplement Facts Label: Docket FDA-2012-N-1210  Comment here now
• Serving Sizes: Docket FDA-2004-N-0258  Comment here now

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