Lose weight

Contamination

admin — Fri, 10 Jul 2009 21:08:18 +0000

Dietary supplements may contain harmful or undesirable substances such as pesticides or heavy metals. Contaminants may be present before a substance is harvested for use as a dietary supplement or may be introduced during processing and packaging.
For example, coral calcium, a dietary supplement said to contain remnants of living coral reefs, may contain signiﬁcant and harmful amounts of lead and other heavy metals.
Consumption of excessive levels of lead can cause neurological problems, increased blood pressure, reproductive impairment, and hearing and sight problems. Scientists are also concerned that people who are allergic to shellﬁsh may experience serious adverse events such as hives, swelling, and breathing problems, because of the presence of these allergens in coral reefs. In 2003 the Sports Nutrition Working Group of the International Olympic Committee Medical Commission
reported that approximately one in ﬁve dietary supplements commonly used by athletes were contaminated. Protein powders; amino acid supplements; creatine; pyruvate; and several vitamin, mineral, and herbal supplements were found to contain steroid-like chemicals that were not identiﬁed on product labels, caused positive doping tests, and were not known to be safe.
Dietary supplements may also contain controlled substances. Acetaminophen, aspirin, antihistamines, and corticosteroids have been found in dietary supplements that did not list them as ingredients. In 2005 the FDA issued a warning about a dietary supplement that contains the antidiabetic agent glyburide after it caused hypoglycemia (dangerously low blood sugar) in several consumers. In 2006 the FDA warned consumers against using several weight-loss dietary supplements that contain chlordiazepoxide HCl (the active ingredient in the drug Librium) and ﬂuoxetine HCl (the active ingredient in the antidepressant Prozac).

Dietary Supplement Composition Variability

admin — Mon, 06 Jul 2009 21:07:31 +0000

Dietary supplements are natural substances that may contain variable amounts of active and inactive ingredients. These amounts depend on several factors, including the age and speciﬁc part of the plant, the composition of the soil in which it was grown, the time of year it was harvested, and how the substance was processed and stored. While manufacturers must label their products with the contents, the recommended daily dose, and how much of the active ingredient each dose contains, dietary supplement composition can vary widely. From bottle to bottle, batch to batch, year to year, and company to company, consumers may not be aware of exactly what they are consuming.
In a 2003 study published in Archives of Internal Medicine, researchers analyzed 880 herbal dietary supplements collected from a variety of sources, including grocery stores, retail pharmacies, discount stores, and health food stores. They compared the dietary supplement ingredients and the recommended daily doses stated on the label with their own laboratory analyses. Of the products sampled, 43 percent were consistent with a standardized pharmacy reference for ingredients and recommended daily doses, 20 percent were consistent regarding ingredients only, and 37 percent were either inconsistent or did not contain enough information on the label to determine consistency. The authors suggested that much of this inconsistency could be attributed to insufﬁcient research on the part of the manufacturer and inadequate understanding of how to ensure consistency in a natural resource.
A study presented at the Sixth International Cartilage Repair Society Symposium in 2006 analyzed ten commercially available dietary supplements containing chondroitin sulfate, which is commonly used to improve joint pain associated with osteoarthritis. Researchers evaluated the ability of the raw materials to inhibit gene expression of three substances involved in cartilage breakdown. These results were compared with a reference standard, which was the chondroitin sulfate supplement used in a previous study, the largest federally funded trial evaluating the supplement’s clinical effects. Only one of the ten supplements inhibited gene expression in a manner equivalent to the reference standard. Two of the supplements had no detectable effect, and the remainder had inconsistent effects on gene expression.

Health Status

admin — Thu, 02 Jul 2009 21:06:52 +0000

Dietary supplements may act differently in different people. As noted by Christine Lewis-Taylor, former director of the FDA’s Ofﬁce of Nutritional Products, Labeling, and Dietary Supplements, “one man’s dose can be another man’s poison.” An individual’s genes and health status help to explain this difference.
Nutritional genomics and metabalomics are growing areas of research that explain the relationship between genetic makeup and nutrition- and metabolism-related outcomes.Certain relationships between nutrients and health outcomes are well characterized. Folate supplementation, for example, is recommended for all women of childbearing age to prevent fetal neural tube defects. By isolating and analyzing the function of the genes responsible for folate metabolism, however, scientists have identiﬁed a genetic variation that predisposes some women to give birth to babies with neural tube defects. This knowledge may eventually allow scientists to target folate supplementation to at-risk individuals.
Stage of life, medical history, and environmental factors such as diet and exercise can affect how a dietary supplement behaves in the body. Several populations are at increased risk of adverse effects of dietary supplements:
• children,
• people of smaller stature,
• elderly people,
• women who are pregnant or breastfeeding,
• people with immune disorders (for example, HIV or AIDS),
• people with cancer,
• malnourished people,
• people with existing or subclinical liver or kidney disease,
• people with a history of gastrointestinal health conditions (such as Crohn’s disease) or surgery (such as gastric bypass surgery),
• people who are hospitalized,
• transplant recipients,
• surgical patients.
While research has revealed the unique nutritional needs in women of childbearing age (for example, 400 microgramsof folate are recommended to prevent neural tube defects in offspring, and if pregnant, supplemental vitamins are recommended), information on the effects of dietary supplements during pregnancy and breastfeeding are extremely limited. This is largely due to ethical considerations:
scientiﬁc studies are not conducted during pregnancy and breastfeeding because of potential risks to the women and their babies. Several herbal dietary supplements historically used during pregnancy have been identiﬁed as harmful.
Certain dietary supplements may cause adverse effects during surgery, including increased or decreased bleeding. Medical or surgical professionals should be consulted several weeks before any scheduled surgery to determine whether dietary supplements should be discontinued.
Perhaps the most common adverse effects of dietary supplements are gastrointestinal, including constipation, diarrhea, or nausea. Gastrointestinal adverse effects are often present when a dietary supplement is ﬁrst added to the diet. Over time, these symptoms may decrease or may cause an individual to discontinue use.
Many dietary supplements are metabolized by the liver and/or kidneys and may therefore cause adverse effects in people with overt or subclinical liver or kidney disease. Adverse effects could include worsening of disease complications or presentation of a previously undiagnosed disease. Other dietary supplements may cause adverse effects in other parts of the body; for example, calendula may cause eye irritation, Ginkgo bilobacan cause skin to become dry, and St. John’s wort may increase sensitivity to the sun.

The Safety of Dietary Supplements

admin — Sun, 28 Jun 2009 21:04:19 +0000

Dietary supplement safety should be of primary concern to consumers. Because they are assumed to be safe unless proven otherwise, dietary supplements present special safety challenges. In 2000 the FDA received 500 dietary supplement adverse event reports; that number rose to 553 in 2001 and to 1214 in 2002. Adverse events caused by dietary supplements vary from mild to severe and may be inﬂuenced by individual health status (medical history and genetic makeup), dietary supplement composition and dosage (including levels of active and inactive ingredients), and concomitant consumption of other substances (including foods, beverages over-the-counter and prescription drugs, and other dietary supplements).

Responsibilities carried out by the Commission on Dietary

admin — Sat, 20 Jun 2009 21:03:17 +0000

Supplements are now being performed by the Ofﬁce of Nutritional Products, Labeling, and Dietary Supplements’ Division of Dietary Supplement Programs, which comprises a regulations and review team, a compliance and enforcement team, and a clinical review team. Led by Dr. Susan Walker, the division creates policies, regulations, and guidance documents to ensure the safe manufacture and labeling of dietary supplements and reviews safety information submitted by dietary supplement manufacturers 75 days before the marketing of a product to ensure that it is reasonably expected to be safe.
The DSHEA also called for the creation of the Ofﬁce of Dietary Supplements (ODS), which is housed within the National Institutes of Health and is responsible for facilitating research into the role of dietary supplements in disease prevention and health promotion. The mission of ODS is to strengthen knowledge about dietary supplements by evaluating available research and stimulating and supporting more scientiﬁc trials, as well as by educating people about the cur- rent state of knowledge. As part of their mission, ODS hosted the 2000 National Nutrition Summit and created numerous resources, including Computer Access to Research on Dietary Supplements, International Bibliographic Information on Dietary Supplements, Annual Bibliographies of Signiﬁcant Advances in Dietary Supplement Research, and Dietary Supplement Ingredient and Labeling databases. The ODS’s 2004–2009 strategic plan comprises ﬁve major goals: (1) expanding the evaluation of dietary supplements in reducing the risk for chronic disease; (2) fostering research on dietary supplements for optimal health and performance; (3) enhancing understanding of the basic effects of dietary supplements on biological systems; (4) improving methodologies; and (5) expanding outreach and education.

Good Manufacturing Practices

admin — Tue, 16 Jun 2009 21:02:12 +0000

The DSHEA gave the FDA the authority to establish special good manufacturing practices for dietary supplements. In March 2003 the FDA released its “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices,” which addresses important components of dietary supplement manufacture, including design and construction of manufacturing facilities, quality-control procedures, testing of the ﬁnal product(s) or incoming and in-process materials, management of consumer complaints, and record keeping and ﬁling of compliance with these standards. The basic tenets of the current good manufacturing practices require that dietary supplement manufacturers use current industry standards in the processing of dietary supplements to avoid contamination (by pesticides, heavy metals, or other impurities) and improper labeling and to ensure that product labels accurately reﬂect the identity, purity, quality, strength, and composition of dietary supplements. The following are some examples of product quality problems that these rules are meant to address:
• contains more of the active or inactive ingredients than listed on the label;
• contains less active ingredients than listed on the label;
• contains the wrong ingredient(s);
• contains a drug contaminant;
• contains other contaminant(s), such as bacteria, mold, pesticide, or lead;
• package contains foreign material, such as glass;
• improper packaging and/or mislabeled product.
The “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices” was open to public comment for a year before it was to be considered ﬁnal. After approval, dietary supplement companies would have 36 months to implement the changes necessary to comply with the rule. Until then, dietary supplement manufacturers were to follow good manufacturing practices for foods. During the comment period, however, the FDA received more than 1600 pages from consumers and members of the dietary supplement industry. A ﬁnal rule therefore has been delayed and is expected in late 2006 (for current information, see http://www.cfsan.fda.gov/dms/ds-ind.html#GMPS).
Creation of New Government Entities
Appointed in 1995, the Commission on Dietary Supplements directs the labeling of dietary supplements, essentially to determine how to provide scientiﬁcally valid information about them. The ﬁrst commission comprised scientists from various U.S. universities with expertise in dietary supplements, a member of the Council for Responsible Nutrition, a Seton Hall University School of Law professor, a public relations specialist, and a representative from the Herb Research Foundation.

Additional Information Given to Consumers

admin — Fri, 12 Jun 2009 21:01:41 +0000

Manufacturers of dietary supplements often seek to promote their product by providing supporting material such as a scientiﬁc study or the statement of a medical or nutrition professional. Under certain conditions, this additional material is not considered to be “labeling,” per se, and is therefore not regulated in the same fashion.
If the manufacturer uses a reprinted scientiﬁc article, it must be printed in its entirety and must not be accompanied by any added information. Additional publications used in connection with the sale of dietary supplements cannot be misleading, cannot promote a particular manufacturer or brand, must present a balanced view of the available scientiﬁc evidence, and must be physically separate from the dietary supplements in the store.

Health Claims on Dietary Supplement Labels

admin — Mon, 08 Jun 2009 21:01:05 +0000

The use of health claims on food products is regulated by the Nutrition Labeling Education Act of 1990.
Health claims describe the relationship between a speciﬁc nutrient and a disease or condition. In order to appear on the food or dietary supplement label, health claims must be evaluated and preapproved by the FDA based on “signiﬁcant scientiﬁc agreement.” Few such health claims have been authorized by the FDA.
While a dietary supplement can never be claimed to “diagnose, prevent, mitigate, treat, or cure” a speciﬁc disease, the DSHEA allows use of speciﬁed statements on the labels of dietary supplements. These statements, known as structure-function claims, may describe how the product affects the structure or function of the body or the overall well-being of the consumer. Before making such statements on a label, however, manufacturers of dietary supplements must prove that the nutritional support statement is truthful and not misleading, and they must notify the FDA within 30 days of making the statement. When a nutritional support statement appears, the label must also state, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Labeling

admin — Thu, 04 Jun 2009 21:00:14 +0000

Labels must include the word supplement and identify the product as a dietary supplement. The required information on dietary supplement labels includes the name and quantity of each nutrient and dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (except inert ingredients) in the blend. Since 1997 all supplements must bear a label entitled “Supplement Facts,” which is very similar in format and content to the “Nutrition Facts” label that appears on all food and beverages marketed in the United States. Labels on herbal and botanical products must state which part of the plant the contents come from.
Some dietary supplements are included in ofﬁcial compendia, such as the U.S. Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, or the National Formulary. If a supplement is included in a compendium, it must correspond with the speciﬁcations of that compendium. For dietary supplements not included in ofﬁcial compendia, the label must correctly identify each substance and the amount in the supplement.
Dietary supplement labels must also contain nutritional information, including ingredients present in signiﬁcant amounts, and ﬁrst listing those for which the FDA has established %DVs. Labels must also include the quantity per serving for each dietary ingredient and may include the source of the ingredients.
The FDA published the Dietary Supplement Labeling Guide in 2005. This guide was created in response to numerous questions from the dietary supplement industry regarding all legislation relevant to dietary supplement labels.

Important Deﬁnitions

admin — Fri, 29 May 2009 20:59:55 +0000

According to the DSHEA, a dietary supplement is a product 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;
• is not represented as a conventional food or as a food replacement;
• is labeled on the container’s front panel as being a dietary supplement;
• includes products such as an approved new drug, certiﬁed antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certiﬁcation, or license (unless waived by the secretary of the Department of Health and Human Services).
The DSHEA presumes that ingredients introduced prior to October 15, 1994, are safe. A new dietary ingredient, on the other hand, is an ingredient not sold in the United States in a dietary supplement prior to that date or one that is part of a dietary supplement introduced on or after October 15, 1994. At least 75 days before marketing a dietary supplement containing a new dietary ingredient, manufacturers must provide the FDA with their basis for deeming the ingredient “reasonably expected to be safe.”
If they meet the criteria above, botanicals may be considered dietary supplements. A botanical is a plant, or part of a plant, that is used for one or more of its speciﬁc characteristics, including medicinal properties, ﬂavor, and scent; herbs are a subset of this group, usually the green, leafy portion of the plant. Botanicals are identiﬁed by Latin names designating the genus and species of the plant. Many botanicals, however, have numerous common names or are identiﬁed only by their genus. For example, the commonly known dietary supplement black cohosh (Cimicifuga racemosa) is also known as baneberry, black snakeroot, bugwort, cohosh bugbane, rich weed, rattle root, solvlys, and squaw root, to name a few. Botanicals can be sold in many forms, including fresh or dried, as liquid or solid extracts, in tablets and capsules, as loose powders, and in tea bags.
The intended use of a consumable product is essentially what determines its classiﬁcation—and therefore its regulation—as a food, drug, or dietary supplement. Drugs are created to treat, cure, or somehow mitigate a disease or condition. A dietary supplement cannot claim to have these effects; if such a claim is made by the manufacturer of a dietary supplement, the substance must then be regulated as a drug. However, a manufacturer can claim a supplement is “used for” anything at all, even though it may have no effect.