Tuesday, August 28, 2007

Documentary Film On Obesity Casting People Scammed By Weight Loss Gimmicks

Documentary Film On Obesity Casting People Scammed By Weight Loss Gimmicks
Jimmy Moore
October 17, 2006

The following is a reprint from the blog "Livin' La Vida Low-Carb":

A full-length feature film on obesity set to begin shooting soon

I have some exciting news for anyone who has ever felt like they have been scammed by any of the literally tens of thousands of weight loss gimmicks out there suckering people out of their money on a daily basis. A special documentary film that will be appearing before millions of interested moviegoers is looking to cast people who have experienced any lasting side effects from being on any specific weight loss products.

They want to hear YOUR story if you are willing to share the specific names of the companies that manufacture and distribute any products that you feel are unsafe, unhealthy or just plain don't work. This is an ambitious undertaking and it is completely under wraps at this point since they seek to expose a lot of fraudulent activities going on right here in America today. They have asked me to act as the liason between you and them, so send me your stories if you want to be involved in this historic and quite possibly culture-influencing documentary film.

You should e-mail me the following information:

1. Your age, name, address and telephone number.

2. The name of the weight loss product you took.

3. The name of the company and/or store where you bought it.

4. When you took the product and for how long.

5. What the adverse side effect was from taking that product.

Be sure to include all of the above information so the producers of the documentary can follow-up with you if they are interested in using your story in the film. Keep in mind that you may be asked to appear on camera to talk about your experience, so please do not submit your information unless you are ready, willing, and able to have it used in the movie.

I have been hoping for a major cultural project like this to come along to continue the education process begun by Morgan Spurlock in his highly successful, critically acclaimed documentary feature film Supersize Me and I am honored to be a part of making this new project come to the silver screen as well.

The makers of the film have asked me to share about my low-carb weight loss success story for the film as well, so this is truly a privilege and an exciting opportunity for me to spread the word about "Livin' La Vida Low-Carb" to an even larger audience. In fact, they WANT me to talk about my blog in the film so that others can come here to interact with others who truly cares about helping them learn more about losing weight and getting healthy. This is exactly the kind of open-minded passion that I expect will drive this film to great success.

Here's just a little taste of what this documentary will be about:

"The public needs to know what is truth and what is false. This film will explore all of the information and help to bring the public knowledge in a style that will also be very entertaining and visually exciting. With a fitness expert as the narrator of this film, we will seek out why there is a epidemic of obesity, we will talk with renowned doctors, medical experts, even Senators and Congressmen who have access to the funds to help civilians get the right information. We will hear from experts in the field of weight control who have a firsthand look into the problem of obesity. And yes, we will expose as many fly-by-night contraption and weight loss supplement companies as we can to keep the public informed.

There are many garbage supplements offered for sale to the public that are not necessarily all targeted for fat loss, since some are also alleged muscle builders. Also, the ephedrine scare was not based on the truth, and was in fact, engineered by the pharmaceutical industry in order to have ephedrine removed as competition for useless fat-loss drugs, such as Meridia. In addition, the false claims made for sports supplements will be explored.

Most importantly, this film will provide solutions to the issue of obesity by arming the public with the weapon of knowledge. It will have the audience enjoying the fact-finding storyline that will be continuously threaded throughout the movie. In the end, we will be more informed and equipped to solve this epidemic of obesity that is sweeping our nation today."

Are you getting excited? YOU SHOULD BE because this is something that those of us who are promoting healthy and permanent lifestyle changes so desperately desire for our fellow citizens: educating them about the truth concerning their diet, health, weight, nutrition and fitness. This isn't a game and the obesity epidemic has already gone too far.

Could this feature film documentary be the beginning of the turnaround in the United States as it relates to the subject of obesity? Will we one day look back on the impact of this film and realize just how much it permanently altered the direction of our country for the better? That remains to be seen, but the thrilling part is that it is coming whether the special interest groups who are keeping Americans fat want it to or not. And when the movie reveals the truth, all bets are off!

Won't you be a part of this historical project? If you are interested, email Jimmy here: livinlowcarbman@charter.net

Pet Obesity

Thanks to more food and less exercise, an increasing number of pet dogs in Ahmedabad are now suffering from pet obesity.
The 'weighty' issue has moved from the man's world to the dog's world. Lifestyle changes sweeping across Indian homes are now affecting the health of pet dogs. Thanks to more food and less exercise, an increasing number of pet dogs in India are now suffering from pet obesity and Ahmedabad seems no different.

Metabolic rates are definitely a matter of concern even for animals. High carb diet and little exercise can make dogs fat and lethargic. Shivaji Talekar, a vet elaborates : "Every day four-five dogs come to my clinic with problems related to pet obesity. Most of these dogs are obese because of their owners' carelessness. Though in certain cases, hormonal imbalance and sterilisation can also lead to pet obesity."

With increase in income and improved lifestyle, pet owners are now becoming too indulgent about their dogs' food intake resulting in pet obesity and sluggishness. Talking about his pet Labrador (who weighs 41 kilos, and is 11 kilos overweight), Hardik Patel says, "My dog simply loves food- - from pastries, chocolates , cakes to eggs," adding, "he will never eat chapatis without ghee. Whenever a family member sits down for a meal, my dog wants a bite for himself. To top it all, he's a lazy fellow and loves sleeping ." But is it fair to put the blame on the dog?

Rekha Ketan Mistry agrees that her three-and-half year old pug is "on the heavier side. He is plump. For his diet, I usually prepare khichdi with seasonal vegetables. Though he goes for walks everyday, he needs to exercise more."

Friya Javeri, a vet, says, "A dog's health is the reflection of his/her owner's lifestyle. These days owners don't pay much attention to their pets' health. Most people also think that feeding a dog is the best way to shower affection, which is wrong. Once dogs become obese, they have problem exercising."

Experts agree that exercise is a must for dogs as it makes them both mentally and physically active. "Dogs like to wander and that's helpful for their muscle movement. Daily exercise makes them agile and confident," says Javeri.

Though people are now hiring dog-trainers but that doesn't seem to help much. Says Chirag Bhatt, a dog lover, "Very few people do any research before bringing a pet home. There's no point in keeping a dog at home if you don't have time. We need to create awareness about different breeds of dogs and their specific health requirements among owners."

What's the best way to fight pet obesity? "The answer is low fat diet. Once the dog loses weight, it should be put on maintenance diet. Exercise and low fat diet keeps a dog healthy," says Taleka.

And remember, the way to a dog's heart is not through his stomach.

deepika.sahu@timesgroup.com
Pet Obesity

Obesity & Insurance

The Obesity Action Coalition (OAC) issued a plea yesterday to both insurers and employers asking that they increase availability of treatment for the deadly disease of obesity and morbid obesity. The request comes after the recent publication of a study in the New England Journal of Medicine (NEJM) that indicated a strong link between obesity interventions and reduced mortality rates.

The epidemic of obesity is growing in rampant proportions with one in four Americans affected by this disease. There are more than ninety-three million Americans as of now with that number expected to reach 120 million over the next five years. The causes of obesity are numerous and complex and can be direct factors and indirect ones. Obesity is the result of an energy imbalance that occurs over a long period of time. An energy imbalance within obese individuals can be caused several different ways with the three main culprits; behavior, environment, and genetics.

There are many who do not recognize obesity as a disease. The OAC works diligently to address this issue and this serious health epidemic by being an advocate that educates and promotes the increase of prevention methods and making safe treatment actions more readily available. These safe treatment options include; nutrition counseling; supervised weight-loss by a physician with or without the aid of medication; and of bariatric surgery for qualified candidates.

One of the studies led by Ted D. Adams, PhD and MPH indicated extraordinary results. It is one of the first-ever studies that has proven that deliberate weight-loss can lead to living better and longer. After experiencing bariatric surgery, the incidence of death by cancer, heart disease, and diabetes were drastically reduced.

Joseph Nadglowski, Jr., OAC President and CEO, stated that obesity is not a cosmetic problem and the study in NEJM clearly identified the fact that obesity interventions such as bariatric surgery does indeed save lives. He qualified further that it is now time for insurers and employers to consider obesity management services an important concern needing immediate attention. When this gets done, those affected by this disease and their health care providers can begin to fight and improve their quality of life and longevity.

The OAC aims to uplift those affected by obesity as well as members of their families through education, support, and working towards eliminating the stigma associated with this disease

Obesity & Insurance

ODS Vitamin D Conference, Sept. 5-6

Background

Vitamin D is a unique nutrient because its needs can be met in two distinct ways: by endogenous production from sun exposure, or from foods and dietary supplements. In addition to calcium metabolism, accumulating evidence indicates other roles in human health, including immune function, reduction of inflammation, and effects on cell proliferation, differentiation, and programmed cell death. Even as its importance to health expands, concerns about the sufficiency of vitamin D in the population are growing. Reports of rickets (the classic vitamin-D deficiency disease) and low blood levels of the biomarker of vitamin D status—25(OH)D—among various subgroups of the U.S. population raise concerns about current public health approaches to ensure vitamin D adequacy.

The first NIH conference on Vitamin D and Health in the 21st Century was held in 2003. Subtitled Bone and Beyond, it considered knowledge regarding the measurement and maintenance of vitamin D status and the development of programs to reduce the prevalence of insufficiency. It also identified research needs, including the following:

Better definitions of vitamin D status with meaningful cutoff values and biomarkers that have functional relevance and validated assessment methods
Dose-response relationships between sunlight exposure and endogenous vitamin D synthesis with specific health outcomes in various racial/ethnic groups
Investigations of genetic polymorphisms to identify tissue-specific roles of vitamin D
Exploration of the relationships of obesity and weight loss on vitamin D status
Improved methods for assessing vitamin D intakes, particularly from fortified foods and supplements
Biomarkers and functional outcomes for bone and non-bone tissue that reflect vitamin D status
A systematic evidence-based review to determine the current state of knowledge

Progress has been made in addressing many of these research needs. Yet, since the 2003 conference, new issues have been raised. For example, reports indicate a growing prevalence of vitamin D insufficiency/deficiency in the U.S. population. They also suggest that vitamin D inadequacy occurs at blood levels previously viewed as adequate. It is time to assess current knowledge of the efficacy and safety of vitamin D to identify new research needs that will help ensure optimal vitamin D status across the life cycle. For this reason, the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) will convene a conference on Vitamin D and Health in the 21st Century—An Update September 5–6, 2007, in Bethesda, Maryland. The goals of the conference are as follows:

Evaluation of the efficacy and safety of vitamin D across the life cycle considering the evidence-based review produced through the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center Program, and research and related tools that have become available since the 2003 NIH conference, Vitamin D and Health in the 21st Century—Bone and Beyond
Presentation of current data/research on vitamin D status, sources of vitamin D, and functional outcomes across the life cycle
Identification of knowledge gaps, methodological challenges, and research needs on vitamin D production, activation, metabolism, and status assessment across the life cycle

The 2-day conference will open with a review of vitamin D production, bioavailability, metabolism, active forms, functions, and metabolic turnover. Vitamin D’s effects on health outcomes across the life cycle and measurement of status will also be critically evaluated. Other topics to be addressed include the impact of dietary intakes and sun exposure on blood levels of 25(OH)D and its relationship to vitamin D status.

At the conference, invited experts will present information pertinent to these topics and goals. The findings of the AHRQ evidence-based review on vitamin D will also be presented. Each of the four sessions will include a panel of the presenters who will address questions relevant to the session topic and suggest future research needs. Attendees will have opportunities to engage in discussions with the panels. Each panel’s summary presentation will become part of the conference record and be used by organizers to compile conference proceedings and to inform NIH’s research agenda.

This conference will be of interest to scientists and health professionals with a background and/or interest in vitamin D.

Continuing Professional Education
Continuing Professional Education Credits will be awarded for the conference by the Commission on Dietetic Registration. The Vitamin D Conference as been approved for a maximum of 14 credits at CPEU Level 2.

FDA Issues Dietary Supplements Final Rule

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit http://www.fda.gov/consumer/updates/dietarysupps062207.html.

Botanical Dietary Supplements: Background Information

What is a botanical?

A botanical is a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent. Herbs are a subset of botanicals. Products made from botanicals that are used to maintain or improve health may be called herbal products, botanical products, or phytomedicines.

In naming botanicals, botanists use a Latin name made up of the genus and species of the plant. Under this system the botanical black cohosh is known as Actaea racemosa L., where "L" stands for Linneaus, who first described the type of plant specimen. In the Office of Dietary Supplements (ODS) fact sheets, we do not include such initials because they do not appear on most products used by consumers.

Can botanicals be dietary supplements?

To be classified as a dietary supplement, a botanical must meet the definition given below. Many botanical preparations meet the definition.

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.

How are botanicals commonly sold and prepared?

Botanicals are sold in many forms: as fresh or dried products; liquid or solid extracts; and tablets, capsules, powders, and tea bags. For example, fresh ginger root is often found in the produce section of food stores; dried ginger root is sold packaged in tea bags, capsules, or tablets; and liquid preparations made from ginger root are also sold. A particular group of chemicals or a single chemical may be isolated from a botanical and sold as a dietary supplement, usually in tablet or capsule form. An example is phytoestrogens from soy products.

Common preparations include teas, decoctions, tinctures, and extracts:

A tea, also known as an infusion, is made by adding boiling water to fresh or dried botanicals and steeping them. The tea may be drunk either hot or cold.
Some roots, bark, and berries require more forceful treatment to extract their desired ingredients. They are simmered in boiling water for longer periods than teas, making a decoction, which also may be drunk hot or cold.
A tincture is made by soaking a botanical in a solution of alcohol and water. Tinctures are sold as liquids and are used for concentrating and preserving a botanical. They are made in different strengths that are expressed as botanical-to-extract ratios (i.e., ratios of the weight of the dried botanical to the volume or weight of the finished product).
An extract is made by soaking the botanical in a liquid that removes specific types of chemicals. The liquid can be used as is or evaporated to make a dry extract for use in capsules or tablets.

Are botanical 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 (also 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 for standardization in the United States as it applies to botanical 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.

Ideally, the chemical markers chosen for standardization would also be the compounds that are responsible for a botanical's effect in the body. In this way, each lot of the product would have a consistent health effect. However, the components responsible for the effects of most botanicals have not been identified or clearly defined. For example, the sennosides in the botanical senna are known to be responsible for the laxative effect of the plant, but many compounds may be responsible for valerian's relaxing effect.

Are botanical dietary supplements safe?

Many people believe that products labeled "natural" are safe and good for them. This is not necessarily true because the safety of a botanical depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used.

The action of botanicals range from mild to powerful (potent). A botanical with mild action may have subtle effects. Chamomile and peppermint, both mild botanicals, are usually taken as teas to aid digestion and are generally considered safe for self-administration. Some mild botanicals may have to be taken for weeks or months before their full effects are achieved. For example, valerian may be effective as a sleep aid after 14 days of use but it is rarely effective after just one dose. In contrast a powerful botanical produces a fast result. Kava, as one example, is reported to have an immediate and powerful action affecting anxiety and muscle relaxation.

The dose and form of a botanical preparation also play important roles in its safety. Teas, tinctures, and extracts have different strengths. The same amount of a botanical may be contained in a cup of tea, a few teaspoons of tincture, or an even smaller quantity of an extract. Also, different preparations vary in the relative amounts and concentrations of chemical removed from the whole botanical. For example, peppermint tea is generally considered safe to drink but peppermint oil is much more concentrated and can be toxic if used incorrectly. It is important to follow the manufacturer's suggested directions for using a botanical and not exceed the recommended dose without the advice of a health care provider.

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

It is difficult to determine the quality of a botanical 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.

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

Scientists use several approaches to evaluate botanical 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 botanical 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 botanical dietary supplements?

Medical libraries are one source of information about botanical 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 about dietary supplements see Dietary Supplements: Background Information (http://ods.od.nih.gov/factsheets/dietarysupplements.asp) from the Office of Dietary Supplements (ODS), available at ods.od.nih.gov.

Dietary Supplements: Background Information

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?

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).

Obesity