Tag Archive : Vitamins

What is a Dietary Supplement? ———Sourced from Office of Dietary Supplements

97-of-dietitians-recommend-supplements-CRN-survey_dnm_headlineArticle is sourced directly from the Office of Dietary Supplements (ODS)

What is a dietary supplement?

As defined by Congress in the Dietary Supplement Health and Education Act (http://www.fda.gov/opacom/laws/dshea.html#sec3), which became law in 1994, a dietary supplement is a product (other than tobacco) that

  • is intended to supplement the diet;
  • contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
  • is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
  • is labeled on the front panel as being a dietary supplement.

What is a new dietary ingredient?

A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994.

Are dietary supplements different from foods and drugs?

Although dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and from drugs. Whether a product is classified as a dietary supplement, conventional food, or drug is based on its intended use. Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.

What claims can manufacturers make for dietary supplements and drugs?

The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.

The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim (http://www.cfsan.fda.gov/~dms/hclaims.html). Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it can not mention any specific disease. Structure/function claims do not require FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market (http://www.cfsan.fda.gov/~dms/ds-labl.html#structure). Product labels containing such claims must also include a disclaimer that reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

How does FDA regulate dietary supplements?

In addition to regulating label claims, FDA regulates dietary supplements in other ways. Supplement ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans. For a new dietary ingredient (one not sold as a dietary supplement before 1994) the manufacturer must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons.

Manufacturers do not have to provide FDA with evidence that dietary supplements are effective or safe; however, they are not permitted to market unsafe or ineffective products. Once a dietary supplement is marketed, FDA has to prove that the product is not safe in order to restrict its use or remove it from the market. In contrast, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective.

The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.

What information is required on a dietary supplement label?

FDA requires that certain information appear on the dietary supplement label:

General information

  • Name of product (including the word “supplement” or a statement that the product is a supplement)
  • Net quantity of contents
  • Name and place of business of manufacturer, packer, or distributor
  • Directions for use

Supplement Facts panel

  • Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV), if established
  • If the dietary ingredient is a botanical, the scientific name of the plant or the common or usual name standardized in the reference Herbs of Commerce, 2nd Edition (2000 edition) and the name of the plant part used
  • If the dietary ingredient is a proprietary blend (i.e., a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight

Other ingredients

  • Nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders; listed by weight in descending order of predominance and by common name or proprietary blend

The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean that no adverse effects are associated with the product. A label for a fictitious botanical product is available at http://vm.cfsan.fda.gov/~acrobat/fdsuppla.pdf.

Does a label indicate the quality of a dietary supplement product?

It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.

FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.

Are dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements. Because of this, the term “standardization” may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word “standardized” on a supplement label does not necessarily indicate product quality.

What methods are used to evaluate the health benefits and safety of a dietary supplement?

Scientists use several approaches to evaluate dietary supplements for their potential health benefits and safety risks, including their history of use and laboratory studies using cell or animal studies. Studies involving people (individual case reports, observational studies, and clinical trials) can provide information that is relevant to how dietary supplements are used. Researchers may conduct a systematic review to summarize and evaluate a group of clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis of data combined from many studies.

What are some additional sources of information on dietary supplements?

Medical libraries are one source of information about dietary supplements. Others include Web-based resources such as PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=nih) and FDA (http://www.cfsan.fda.gov/~dms/ds-info.html). For general information on botanicals and their use as dietary supplements please see Background Information About Botanical Dietary Supplements (http://ods.od.nih.gov/factsheets/botanicalbackground.asp).

Disclaimer

Reasonable care has been taken in preparing this document and the information provided herein is believed to be accurate. However, this information is not intended to constitute an “authoritative statement” under Food and Drug Administration rules and regulations.

About ODS

The mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

General Safety Advisory

  • The information in this document does not replace medical advice.
  • Before taking an herb or a botanical, consult a doctor or other health care provider-especially if you have a disease or medical condition,

take any medications, are pregnant or nursing, or are planning to have an operation.

  • Before treating a child with an herb or a botanical, consult with a doctor or other health care provider.
  • Like drugs, herbal or botanical preparations have chemical and biological activity. They may have side effects. They may interact with certain medications. These interactions can cause problems and can even be dangerous.
  • If you have any unexpected reactions to an herbal or a botanical preparation, inform your doctor or other health care provider.

Information sourced from the Office of Dietary Supplements for education purposes only. This article is an attempt to educate and inform consumers on what is a dietary supplement. Sourced:from http://www.fda.gov/opacom/laws/dshea.html#sec3

Life Priority, established in 1994, offers supplements that are scientifically-formulated, results-oriented, and GRAS (Generally Recognized As Safe) and are manufactured at USDA and FDA inspected facilities.
*The products and statements made about specific products on this web site have not been evaluated by the United States Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure or prevent disease. All information provided on this web site or any information contained on or in any product label or packaging is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional. You should not use the information on this web site for diagnosis or treatment of any health problem. Always consult with a healthcare professional before starting any new vitamins, supplements, diet, or exercise program, before taking any medication, or if you have or suspect you might have a health problem.
*Any testimonials on this web site are based on individual results and do not constitute a guarantee that you will achieve the same results.
Life Priority - Eyes on Vitamin D

Eyes on D3

Thanks to recent research, the power of vitamin D3 is making headlines again. And, as the weather turns warmer, the timing couldn’t be more perfect to talk about the benefits of such an environment-related key to our health.

Life Priority - Eyes on Vitamin D

Also known as the “sunshine vitamin,” vitamin D3 is manufactured in the body’s skin when it is exposed to sunlight. To date, it has proven effective in preventing cancer, enhancing bone health, lowering blood pressure and decreasing depression. And now its anti-inflammatory properties are being highlighted through a recent study of aging mice.

In this study, a group of mice with age-associated visual impairments caused by retinal inflammation were given doses of vitamin D3 for a period of six weeks, while another group with the same condition was given a controlled placebo. During that time, the retinal inflammation of the mice receiving D3 injections decreased significantly compared to those receiving the placebo. In fact, the D3 treatments also appeared to positively affect chronic inflammation in other areas of the rodents’ bodies overall.

What does this mean? It means great news for everyone who is fighting to maintain their eyesight as they get older. Simply getting more vitamin D3 could be an easy way to keep your vision intact for as long as you are!

Unfortunately, vitamin D3 only helps if we get adequate amounts of it. With so much of our attention being focused on avoiding the sun and lowering our risk of skin cancer, most of us don’t get the amount of D3 we need in order to reap its benefits.

This summer, instead of avoiding the sun altogether, adopt a balanced approach to sunlight and enjoy the outdoors. You’ll not only boost your mood and lower your risk of various diseases, you’ll also increase your chances for improved eyesight. If opportunities for outdoor activity aren’t readily available for you, consider talking to your doctor about vitamin D3 supplementation. It could be just the thing you need to see clearly for years to come!

Life Priority, established in 1994, offers supplements that are scientifically-formulated, results-oriented, and GRAS (Generally Recognized As Safe) and are manufactured at USDA and FDA inspected facilities.
*The products and statements made about specific products on this web site have not been evaluated by the United States Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure or prevent disease. All information provided on this web site or any information contained on or in any product label or packaging is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional. You should not use the information on this web site for diagnosis or treatment of any health problem. Always consult with a healthcare professional before starting any new vitamins, supplements, diet, or exercise program, before taking any medication, or if you have or suspect you might have a health problem.
*Any testimonials on this web site are based on individual results and do not constitute a guarantee that you will achieve the same results.

Researching the Benefits of Vitamin D for our Bodies

vitamin-d-research-sunlightDo you often think to yourself, “Did I get enough Vitamin D today?” Chances are, no,
you don’t think this. Vitamin D often gets overlooked in our dietary lives. A lot of the time
we are focusing on what will help us lose weight, or what will help us reduce symptoms
of some certain ailment we are facing, but what we don’t know is that research has
shown that Vitamin D can aid in these and much more. Vitamin D can be considered a
multi-tasker with a plethora of benefits for our bodies.

Mood
Observational studies have found a link between Vitamin D and mood levels in older
adults. In these studies, it was found that Vitamin D deficiency could be a risk-factor for
depression brought on later in life. Participants who took Vitamin D supplementation
were found to have an increase in their mood levels.
http://www.jad-journal.com/article/S0165-0327(15)31026-0/abstract

Musculoskeletal
Research has shown that Vitamin D benefits the body’s musculoskeletal functions.
Again, with our Vitamin D deficient lifestyles, people can be more prone to fractures and
muscle weakness. A study found that daily Vitamin D supplementation reduced hip and
non-spinal fractures by 20%. Sufficient Vitamin D levels help with bone mineralization
and keeps them from softening as we get older.

Vitamin D

Mortality
Another study sought out to find an association between Vitamin D and general
mortality. In the study, populations had their Vitamin D levels checked and were
separated based on their Vitamin D statuses. The population with the higher status
results had lower mortality rates than the population that was considered Vitamin D
deficient. This study’s purpose was to generally associate Vitamin D status levels with
risk factors related to mortality.
http://www.danmedj.dk/portal/page/portal/danmedj.dk/dmj_forside/PAST_ISSUE/2015/
DMJ_2015_02/B5008

Heart Health
The heart “flexes” its muscle with the help of Vitamin D. Over time, like other muscles,
the heart can become weaker and even damaged. That, compounded with a Vitamin D
deficiency can cause problems in the long run. Studies found that men who were
Vitamin D deficient were twice as likely to suffer a heart attack. It’s no surprise here that
Vitamin D deficiency is linked to heart issues.

Vitamin D

The list can go on and on about what research says about Vitamin D and its
preventative properties, but the benefits outlined are reason enough for you to make
sure that your Vitamin D levels are up to par. In this day and age and with the modern
lifestyles we live, it’s not hard for us to become deficient. Speak to your doctor about
testing and how you can combat Vitamin D deficiency. They may even recommend
changes in diet or Vitamin D supplementation.