Vitamin D Deficiency

Moral of the story: There is rising awareness that tons of people are vitamin D deficient.  This is BAD.  Get some sun (just a bit every day) and drink your milk (skim to keep your arteries healthy).  If you are very deficient your doctor can give your prescription supplements.

Source: AMA Morning Rounds 8/4/2010

Large part of US population may be deficient in vitamin D.

Writing in the New York Times (7/27, D7) "Personal Health" column, Jane E. Brody reports that "a huge part of the population" may be deficient in vitamin D. Notably, "every tissue in the body, including the brain, heart, muscles and immune system, has receptors for vitamin D, meaning that this nutrient is needed at proper levels for these tissues to function well." Current research suggests that "the effects of a vitamin D deficiency include an elevated risk of developing (and dying from) cancers of the colon, breast and prostate; high blood pressure and cardiovascular disease; osteoarthritis; and immune-system abnormalities that can result in infections and autoimmune disorders like multiple sclerosis, type 1 diabetes, and rheumatoid arthritis."

Moral of the story: STAY AWAY!!

Source: AMA Morning Rounds 8/4/2010

Consumer Reports finds 12 supplements with unsafe ingredients.

ABC World News (8/3, story 8, 1:50, Sawyer) reported, "Dietary supplements are a $27 billion a year business in this country, but Consumer Reports has an alert" on "supplements the magazine says can be dangerous to your health." Consumer Reports' Nancy Metcalf said, "With the dozen supplements that we've identified, we think it's all risk and no benefit."

        The CBS Evening News (8/3, story 6, 1:55, Couric) also reported, "Consumer Reports analyzed data from 1,100 supplements and identified 12 that are linked to serious health problems. These include ingredients in weight loss products...which can cause heart problems and liver damage." Certain other supplements "used for cough...are associated with liver cancer and even death." CBS noted that the "FDA cannot regulate" the supplements, which are labeled as foods, "until after a product is already on the market."

        The Los Angeles Times (8/4, Stein) points out that the list of those that are unsafe include "aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe." The report also "argues that the FDA has not fully used its limited authority granted by the Dietary Supplement Health and Education Act to ban supplement ingredients that may be dangerous." In addition, the FDA was criticized "for not inspecting Chinese factories where many of the raw materials for supplements originate."

        The Washington Post (8/4) adds that supplement manufacturers "routinely, and legally, sell their products without first having to demonstrate that they are safe and effective." WebMD (8/3, Doheny) also covered the story.

Researchers associate low levels of vitamin D with CAD, stroke, heart failure.

Moral of the story: There is a link between the chronic, prevalent low vitamin D levels in the US and all those cardiovascular problems. It may be a tough balance between skin cancer and vitamin D, but the importance of the vitamin D is becoming more clear.

Source: AMA Morning Rounds 11/17/09

Researchers associate low levels of vitamin D with CAD, stroke, heart failure.

The New York Times (11/16, Rabin) "Well" blog reported that, according to research presented Nov. 16 at the American Heart Association conference, "Americans aren't getting anywhere nearly enough of" vitamin D, "and it may be affecting their heart health." After examining data on 27,686 "healthy adults 50 and older whose vitamin D levels had been measured during routine checkups," researchers found that "those who had extremely low levels of the vitamin were almost twice as likely to have died or suffered a stroke than those with adequate amounts." In addition, they "had more coronary artery disease and were twice as likely to have developed heart failure." HealthDay (11/16, Preidt) and CNN (11/17, Mann) also cover the study.

Research suggests 20 percent of US children under 12 may not get enough vitamin D.

The AP (10/26, Tanner) reports that, according to a study published in Pediatrics, "at least one in five US children aged one to 11 don't get enough vitamin D and could be at risk for a variety of health problems, including weak bones." Harvard University researchers analyzed "data from a 2001-06 government health survey of nearly 3,000 children" who had undergone "blood tests measuring vitamin D levels." The investigators found that "about 20 percent of kids" under 12 had "blood levels that are too low." In addition, "applying a less strict, higher cutoff," the study authors found that "two-thirds of children that age, including 90 percent of black kids and 80 percent of Hispanics, are deficient in vitamin D." -AMA daily


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Vitamin C Intake

Moral of the Story: Vitamin C intake is critical and must be a part of your diet, but too much is also bad. You should be receiving plenty of vitamin C in your diet, and if you add a glass of orange juice in the morning there is definitely no need for supplements.

Criteria and Recommendations for Vitamin C Intake

Mark Levine, MD; Steven C. Rumsey, PhD; Rushad Daruwala, PhD; Jae B. Park, PhD; Yaohui Wang, MD

JAMA. 1999;281:1415-1423.

Recommendations for vitamin C intake are under revision by the Food and Nutrition Board of the National Academy of Sciences. Since 1989 when the last recommended dietary allowance (RDA) of 60 mg was published, extensive biochemical, molecular, epidemiologic, and clinical data have become available. New recommendations can be based on the following 9 criteria: dietary availability, steady-state concentrations in plasma in relationship to dose, steady-state concentrations in tissues in relationship to dose, bioavailability, urine excretion, adverse effects, biochemical and molecular function in relationship to vitamin concentration, direct beneficial effects and epidemiologic observations in relationship to dose, and prevention of deficiency. We applied these criteria to the Food and Nutrition Board's new guidelines, the Dietary Reference Intakes, which include 4 reference values. The estimated average requirement (EAR) is the amount of nutrient estimated to meet the requirement of half the healthy individuals in a life-stage and gender group. Based on an EAR of 100 mg/d of vitamin C, the RDA is proposed to be 120 mg/d. If the EAR cannot be determined, an adequate intake (AI) amount is recommended instead of an RDA. The AI was estimated to be either 200 mg/d from 5 servings of fruits and vegetables or 100 mg/d of vitamin C to prevent deficiency with a margin of safety. The final classification, the tolerable upper intake level, is the highest daily level of nutrient intake that does not pose risk or adverse health effects to almost all individuals in the population. This amount is proposed to be less than 1 g of vitamin C daily. Physicians can tell patients that 5 servings of fruits and vegetables per day may be beneficial in preventing cancer and providing sufficient vitamin C intake for healthy people, and that 1 g or more of vitamin C may have adverse consequences in some people.

Author Affiliations: Molecular and Clinical Nutrition Section, Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md (Drs Levine, Rumsey, Daruwala, and Wang); Phytonutrients Laboratory, Beltsville Human Nutrition Research Center, US Department of Agriculture, Beltsville, Md (Dr Park).

Vitamins E and C in the Prevention of Prostate and Total Cancer in Men

Moral of the story: More results from the Physicians' Health Study: Vitamins E and C do not reduce the risk for developing prostate cancer or any other cancer (or cardiovascular disease, as you may remember from the last post).

Vitamins E and C in the Prevention of Prostate and Total Cancer in Men

The Physicians' Health Study II Randomized Controlled Trial

J. Michael Gaziano, MD, MPH; Robert J. Glynn, ScD; William G. Christen, ScD; Tobias Kurth, MD, ScD; Charlene Belanger, MA; Jean MacFadyen, BA; Vadim Bubes, PhD; JoAnn E. Manson, MD, DrPH; Howard D. Sesso, ScD, MPH; Julie E. Buring, ScD

JAMA. 2009;301(1):52-62. Published online December 9, 2008 (doi:10.1001/jama.2008.862).

ABSTRACT

Context Many individuals take vitamins in the hopes of preventing chronic diseases such as cancer, and vitamins E and C are among the most common individual supplements. A large-scale randomized trial suggested that vitamin E may reduce risk of prostate cancer; however, few trials have been powered to address this relationship. No previous trial in men at usual risk has examined vitamin C alone in the prevention of cancer.

Objective To evaluate whether long-term vitamin E or C supplementation decreases risk of prostate and total cancer events among men.

Design, Setting, and Participants The Physicians' Health Study II is a randomized, double-blind, placebo-controlled factorial trial of vitamins E and C that began in 1997 and continued until its scheduled completion on August 31, 2007. A total of 14 641 male physicians in the United States initially aged 50 years or older, including 1307 men with a history of prior cancer at randomization, were enrolled.

Intervention Individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily.

Main Outcome Measures Prostate and total cancer.

Results During a mean follow-up of 8.0 years, there were 1008 confirmed incident cases of prostate cancer and 1943 total cancers. Compared with placebo, vitamin E had no effect on the incidence of prostate cancer (active and placebo vitamin E groups, 9.1 and 9.5 events per 1000 person-years; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.85-1.09; P = .58) or total cancer (active and placebo vitamin E groups, 17.8 and 17.3 cases per 1000 person-years; HR, 1.04; 95% CI, 0.95-1.13; P = .41). There was also no significant effect of vitamin C on total cancer (active and placebo vitamin C groups, 17.6 and 17.5 events per 1000 person-years; HR, 1.01; 95% CI, 0.92-1.10; P = .86) or prostate cancer (active and placebo vitamin C groups, 9.4 and 9.2 cases per 1000 person-years; HR, 1.02; 95% CI, 0.90-1.15; P = .80). Neither vitamin E nor vitamin C had a significant effect on colorectal, lung, or other site-specific cancers. Adjustment for adherence and exclusion of the first 4 or 6 years of follow-up did not alter the results. Stratification by various cancer risk factors demonstrated no significant modification of the effect of vitamin E on prostate cancer risk or either agent on total cancer risk.

Conclusions In this large, long-term trial of male physicians, neither vitamin E nor C supplementation reduced the risk of prostate or total cancer. These data provide no support for the use of these supplements for the prevention of cancer in middle-aged and older men.

Trial Registration clinicaltrials.gov Identifier: NCT00270647

Vitamins E and C in the Prevention of Cardiovascular Disease in Men

Moral of the story: Vitamins are finally coming under scrutiny, and the results are not positive. The Physicians' Health Study is the only randomized trial (consisting of physicians) to look at vitamin use and is thus the only reliable source of information on the effects of vitamins. This study shows that vitamins E and C had no protective benefit in the prevention of cardiovascular disease in men.

Vitamins E and C in the Prevention of Cardiovascular Disease in Men

The Physicians' Health Study II Randomized Controlled Trial

Howard D. Sesso, ScD, MPH; Julie E. Buring, ScD; William G. Christen, ScD; Tobias Kurth, MD, ScD; Charlene Belanger, MA; Jean MacFadyen, BA; Vadim Bubes, PhD; JoAnn E. Manson, MD, DrPH; Robert J. Glynn, ScD; J. Michael Gaziano, MD, MPH

JAMA. 2008;300(18):2123-2133. Published online November 9, 2008 (doi: 10.1001/jama.2008.600).

ABSTRACT

Context Basic research and observational studies suggest vitamin E or vitamin C may reduce the risk of cardiovascular disease. However, few long-term trials have evaluated men at initially low risk of cardiovascular disease, and no previous trial in men has examined vitamin C alone in the prevention of cardiovascular disease.

Objective To evaluate whether long-term vitamin E or vitamin C supplementation decreases the risk of major cardiovascular events among men.

Design, Setting, and Participants The Physicians' Health Study II was a randomized, double-blind, placebo-controlled factorial trial of vitamin E and vitamin C that began in 1997 and continued until its scheduled completion on August 31, 2007. There were 14 641 US male physicians enrolled, who were initially aged 50 years or older, including 754 men (5.1%) with prevalent cardiovascular disease at randomization.

Intervention Individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily.

Main Outcome Measures A composite end point of major cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular disease death).

Results During a mean follow-up of 8 years, there were 1245 confirmed major cardiovascular events. Compared with placebo, vitamin E had no effect on the incidence of major cardiovascular events (both active and placebo vitamin E groups, 10.9 events per 1000 person-years; hazard ratio [HR], 1.01 [95% confidence interval {CI}, 0.90-1.13]; P = .86), as well as total myocardial infarction (HR, 0.90 [95% CI, 0.75-1.07]; P = .22), total stroke (HR, 1.07 [95% CI, 0.89-1.29]; P = .45), and cardiovascular mortality (HR, 1.07 [95% CI, 0.90-1.28]; P = .43). There also was no significant effect of vitamin C on major cardiovascular events (active and placebo vitamin E groups, 10.8 and 10.9 events per 1000 person-years, respectively; HR, 0.99 [95% CI, 0.89-1.11]; P = .91), as well as total myocardial infarction (HR, 1.04 [95% CI, 0.87-1.24]; P = .65), total stroke (HR, 0.89 [95% CI, 0.74-1.07]; P = .21), and cardiovascular mortality (HR, 1.02 [95% CI, 0.85-1.21]; P = .86). Neither vitamin E (HR, 1.07 [95% CI, 0.97-1.18]; P = .15) nor vitamin C (HR, 1.07 [95% CI, 0.97-1.18]; P = .16) had a significant effect on total mortality but vitamin E was associated with an increased risk of hemorrhagic stroke (HR, 1.74 [95% CI, 1.04-2.91]; P = .04).

Conclusions In this large, long-term trial of male physicians, neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events. These data provide no support for the use of these supplements for the prevention of cardiovascular disease in middle-aged and older men.

Trial Registration clinicaltrials.gov Identifier: NCT00270647

FDA reprimands Coca Cola

Moral of the Story: Soda is never good for you, ever.

Department of Health and Human Services
Public Health Service
Food and Drug Administration

College Park, MD 20740

DEC 10 2008

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Muhtar Kent
President and Chief Executive Officer
The Coca-Cola Company
1 Coca Cola Place, NW
Atlanta, GA 30313-2424

Re: CFSAN-OC-09-01

Dear Mr. Kent:

The Food and Drug Administration (FDA) has reviewed the label for your Diet Coke Plus 20 FL OZ (1.25 PT) 591ml. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Your Diet Coke Plus product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC 343(r)(1)(A)] because the product makes a nutrient content claim but does not meet the criteria to make the claim.

Your product bears the term "Plus" as part of its name, and the principal display panel of the product label also includes the language, "Diet Coke with Vitamins & Minerals." The ingredient list includes the following added vitamins and minerals: magnesium sulfate (declared at 10% of the Daily Value (DV) for magnesium in the Nutrition Facts panel), zinc gluconate (declared at 10% of the DV for zinc), niacinamide (declared at 15% of the DV for niacin), pyridoxine hydrochloride (declared at 15% of the DV for vitamin B6), and cyanocobalamine (declared at 15% of the DV for vitamin B12).

Your product is misbranded within the meaning of section 403(r)(1)(A) of the Act because it bears the nutrient content claim "plus" but does not comply with the regulations governing the use of this claim. The term "plus" in "Diet Coke Plus," read in conjunction with the language "Diet Coke with Vitamins & Minerals," meets the definition of a nutrient content claim because it characterizes the product's level of vitamins and minerals, which are nutrients of the type required to be in nutrition labeling (21 CFR 101.13(b)). The term "plus" is defined in 21 CFR 101.54(e). This term may be used on the label or in labeling of foods to describe the level of nutrients (such as vitamins and minerals) in the food, provided that (1) the food contains at least 10 percent more of the Reference Daily Intake or Daily Reference Value for the nutrient per reference amount customarily consumed than an appropriate reference food, (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20, and (3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii).

Your product Diet Coke Plus is a carbonated beverage. The policy on fortification in 21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods such as carbonated beverages. Additionally, the label of your product does not state the identity of a reference food and the percentage (or fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs, as is required for relative claims such as "plus" under 101.13(j)(2). Therefore, the "plus" claim on the label of this product does not meet the requirements of 21 CFR 101.54(e)(1).

The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.

You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

You should direct your written reply to Felicia B. Williams, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.

Sincerely,

/S/

Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
And Applied Nutrition