CEU Update. Dietary Supplements

CEU Update A semi-annual publication of the National Association for Health Professionals June 2014 Issue #0614 Dietary Supplements What is a dieta...
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CEU Update A semi-annual publication of the National Association for Health Professionals

June 2014

Issue #0614

Dietary Supplements What is a dietary supplement? As defined by Congress in the Dietary Supplement Health and Education Act, 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. The U.S. Food and Drug Administration (FDA) requires specific safety information from a manufacturer intending to market a dietary supplement containing a new dietary ingredient. This information is not required for older dietary supplement ingredients. Are dietary supplements different from foods and drugs? Although dietary supplements are regulated by the 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. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or healthrelated 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. 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 1

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. Unlike drug products, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. 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 Non-dietary 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. 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. In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. Manufacturers are now expected to guarantee the identity, purity, strength, and composition of their dietary supplements. For example, the GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product. 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) 2

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? Dietary supplements are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various supplement ingredients varies widely. Some ingredients in dietary supplements have been carefully evaluated. For example, scientists know that calcium and vitamin D are important for keeping bones strong and reducing bone loss. Other supplements, such as many herbal products, need more study to determine their value. Scientists can use several approaches to evaluate dietary supplements for their potential health benefits and risks. They may investigate history of use, conduct laboratory studies using cell or tissue cultures, and experiment with animals. Studies on people (e.g., individual case reports, observational studies, and clinical trials) provide the most direct evidence of a dietary supplement's effects on health and patterns of use.

Botanical Dietary Supplements 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, 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; tablets, capsules, powders; tea bags; and other forms. 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. 3

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 constituents 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 4

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. In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. Manufacturers are now expected to guarantee the identity, purity, strength, and composition of their dietary supplements. For example, the GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product. What methods are used to evaluate the health benefits and safety of a botanical dietary supplement? Like other dietary supplements, botanicals are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various botanical ingredients varies widely. Some botanicals have been evaluated in scientific studies. For example, research shows that St. John's Wort may be useful for short-term treatment of mild to moderate depression. Other botanical dietary supplements need more study to determine their value. Scientists can use several approaches to evaluate botanical dietary supplements for their potential health benefits and risks. They may investigate history of use, conduct laboratory studies using cell or tissue cultures, and experiment with animals. Studies on people (e.g., individual case reports, observational studies, and clinical trials) provide the most direct evidence of a botanical supplement's effects on health and patterns of use.

Top Selling Botanicals These are the top 10 best-selling botanicals in the U.S. today . Cranberry (Vaccinium macrocarpon) Cranberry juice and concentrated cranberry extracts, which contain a class of antioxidants known as anthocyanins, have recently become widely used for the prevention (and occasionally treatment) of urinary tract infections. Clinical studies have shown that it is effective, but not for all populations. The effectiveness of cranberry is thought to be related to its antimicrobial properties and possibly because it prevents bacteria from sticking to the urinary tract. In addition to its utility for treating urinary tract infections, cranberry is also used in holistic therapies that focus on the heart. Accumulating evidence indicates that cranberry, as well as other fruits rich in antioxidants, may reduce the risk of cardiovascular disease by increasing the resistance of LDL to oxidation, inhibition of platelet aggregation, reducing blood pressure, and reducing inflammation in circulatory vessels. Possible Adverse Effects As with other herbs that are known to stop blood from clotting, there is a potential for adverse interactions between cranberry juice or cranberry extracts and anticoagulant (or anti-blood clotting) medications, such as Warfarin. A review of the reported case studies, however, concluded that there was sparse evidence for a clinically relevant interaction between cranberry juice ingestion and anticoagulant medicines. Contraindications Because cranberry juice is acidic, it has been suggested that ingestion of large amounts may increase the risk of kidney stone formation. However, a 2005 study concluded that cranberry juice slightly increased some risk factors (by elevating levels of urinary calcium and oxalate), while decreasing other risk factors. The authors concluded that overall, cranberry does not increase the risk of kidney stone formation. Diabetics should use sweetened cranberry juice with caution to ensure that it remains within 5

the range for glucose tolerance. Ingestion of large amounts of cranberry juice (> 3-4 L/day) can cause diarrhea and other gastro-intestinal symptoms. Saw palmetto (Serenoa repens) Earlier clinical studies in which saw palmetto was compared to finasteride in the treatment of benign prostatic hyperplasia (BPH) report that the herbal preparations were comparable in efficacy. However, more recent studies have found no differences between saw palmetto and placebo. Note that saw palmetto is not effective for the prevention or treatment of prostate cancer. Possible Adverse Effects Saw palmetto is very well-tolerated with rare side-effects. Contraindications There are no significant contraindications or recognized drug/botanical interactions. Soy isoflavones Many plants contain chemicals called phytoestrogens that have effects similar to human estrogen. One example of phytoestrogens are the isoflavones found in soy, red clover, and flaxseed. Americans take isoflavones most commonly to treat menopausal symptoms. Although some studies question the effectiveness of isoflavones, one 2006 study noted that soy protein appears to reduce total cholesterol levels, and red clover reduces triglycerides while increasing HDL cholesterol. Overall, the study concluded that isoflavones in soy and red clover appear to have a "small but positive" effect and would be beneficial for menopausal women. Possible Adverse Effects Rarely, high quantities of soy or isolated isoflavones cause bowel irritation. Contraindications People with allergies to soy or flax should use caution. There is some uncertainty about the safety of high doses in patients with breast cancer. Children should not be given dietary supplements that contain high levels of phytoestrogens because they may affect brain development. Garlic (Allium sativum) Standardized garlic extract is most often used in the U.S. for its putative ability to lower cholesterol and serum triglycerides. However, recent studies indicate that while it does lower serum triglycerides, it does not lower LDL cholesterol. There is some evidence that it may be useful for many other purposes, including stabilizing blood pressure, enhancing immune functions, protecting against infections, and supporting cardiovascular functions. Two recent analyses of clinical studies indicate that garlic extract may be effective for the prevention of stomach and colorectal cancers and is moderately effective in lowering serum cholesterol and triglycerides. Possible Adverse Effects Garlic can cause smelly breath and body odor. Other possible effects are heartburn, flatulence, nausea, and diarrhea. Contraindications There has been some concern about garlic and other herbal supplements hindering the ability of blood to clot and interacting adversely with commonly prescribed anticoagulant (or anti-blood clotting) medicines. However, a recent review and in vivo study found no effect on blood clotting for garlic and four other common herbal supplements in a two-week dosing study, compared with aspirin which markedly inhibited clotting. While the potential for interactions must remain recognized, the initial concerns are overstated, and the emphasis must remain on "potential." There were several reports that garlic extracts may decrease the effectiveness of the anti-retroviral medication Saquinavir, but subsequent studies have not supported these findings. 6

Ginkgo Ginkgo has been well-investigated clinically, particularly for its efficacy in improving memory and cognitive functions in elderly people suffering from impaired cerebral circulation. Some studies state that its benefits are inconsistent or unconvincing. However, numerous other clinical studies have reported positive outcomes of Ginkgo biloba treatment for the prevention of cognitive deficits in the elderly. Part of the difficulty of evaluating these differing outcomes is related to the methods used in each study, such as the selection of the patient populations, length of treatment, dose of medication, and variability in the composition of the treatment medication. Possible Adverse Effects Reports of adverse reactions have been extremely rare. (It may rarely cause GI upset.) Contraindications Can enhance bleeding risk in patients taking anticoagulants or antiplatelet drugs. Echinacea (Echinacea purpurea; E. angustifolia; E. pallida) Echinacea, originally a Native American remedy, has gained popularity for treating the symptoms of colds, flu, and respiratory infections. Some research indicates that echinacea has the potential to boost immune cell response, but only certain preparations of echinacea are able to do so, such as fresh pressed juice or isolated polysaccharides. A meta-analysis of 14 clinical studies on the effects of echinacea on the duration and severity of the common cold indicated that pre-treatment with echinacea reduced the odds of developing a cold by 58 percent and reduced the average duration of the infection by 1.4 days. These and other results support the use of echinacea for prevention and treatment of the common cold. Additional studies are taking place to explore the use of echinacea as a cancer treatment or preventive medicine. Results of a 2005 study with mice found that daily consumption of echinacea was preventive; it extended the life span of aging mice, significantly lessened the effects of leukemia, and it extended the life span of the mice with leukemia. While the results of this mouse study are promising, it is important to keep in mind that animal studies cannot always be assumed to demonstrate clinical efficacy in humans. Possible Adverse Effects Echinacea is very well-tolerated. Contraindications People with allergies to ragweed may be allergic to echinacea. There are no reported drug/botanical interactions. Milk Thistle Milk thistle is most commonly used to support the liver and as a liver protectant. It contains powerful antioxidants known as flavonolignans. The potential benefit of milk thistle in the treatment of liver diseases remains a controversial issue, with two recent review studies coming to different conclusions. Adverse effects No severe adverse effects reported, although some people may experience loose stools. Contradications Concerns have been expressed about possible interference with the metabolism of the prescription drug Indinivir, but clinical studies have found no evidence for such interference. Black Cohosh (Acteae racemosa; formerly:Cimicifuga racemosa) Black cohosh is commonly used to treat menopausal symptoms, especially hot flashes. Some recent studies indicate that combining Black cohosh with St. John's Wort could be more effective than Black 7

cohosh alone in treating menopausal symptoms. Possible Adverse Effects Black cohosh may cause mild GI upset. There are some reports of other side effects with doses higher than 160 mg/day, including nausea, vertigo, uterine contractions, and bradycardia. Contraindications There are no known drug/botanical interactions. St John's Wort Americans commonly take St. John's wort (Hypericum perforatum) to combat symptoms of depression. Standardized extracts of St. John's wort have been tested clinically and shown to be an effective alternative to SSRIs or tricyclic antidepressants for the treatment of mild to moderate depression. A recent Cochrane review also suggests that the herb is as effective as standard antidepressants for major depression. Recent studies found that St. John's wort may be effective in maintaining smoking cessation. More studies need to be done in this area. If St. John's wort proves to be effective in additional large studies, it could be considered a less expensive, and easily accessible, tool for those who wish to quit smoking. Possible Adverse Effects Rare effects include nausea, rash, photosensitivity, sexual dysfunction. Contraindications There is considerable concern regarding possible interactions of this herb with prescription medicines, and patients on any medication should consult their physicians prior to using it. Otherwise, it is generally considered safe. Ginseng (Panax ginseng; Panax quinquifolius) Chinese or Korean ginseng is most commonly used to increase energy and improve physical and mental performance, enhance immune response, and treat erectile dysfunction. Because of the multifunctionality of ginseng, there are no clinical studies that comprehensively address all aspects of its actions. Possible Adverse Effects In general, ginseng is well-tolerated, with adverse reactions largely being mild and reversible. Reports of severe adverse reactions to ginseng are rare, and many have been associated with the ingestion of excessive doses, which can cause sleeplessness and high blood pressure. One citation that shows up occasionally has been largely discredited and many of the findings retracted by the authors due to poor study design. Contraindications Ginseng should not be used by individuals who have acute infections, especially those involving fever, or high blood pressure. Additionally, ginseng should not be used when using large amounts of caffeine or other stimulants. Patients who are preparing for or have undergone organ transplantation should also avoid ginseng.

Health Fraud Scams You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see claims like “miracle cure,” “revolutionary scientific breakthrough,” or “alternative to drugs or surgery.” Health fraud scams have been around for hundreds of years. The snake oil salesmen of old have morphed into the deceptive, high-tech marketers of today. They prey on people’s desires for easy solutions to difficult health problems—from losing weight to curing serious diseases like cancer. According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically 8

proven safe and effective for that purpose. Scammers promote their products through newspapers, magazines, TV infomercials and cyberspace. You can find health fraud scams in retail stores and on countless websites, in popup ads and spam, and on social media sites like Facebook and Twitter. Not Worth the Risk Health fraud scams can do more than waste your money. They can cause serious injury or even death, says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Using unproven treatments can delay getting a potentially life-saving diagnosis and medication that actually works. Also, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.” Coody says fraudulent products often make claims related to: • weight loss • sexual performance • memory loss • serious diseases such as cancer, diabetes, heart disease, arthritis and Alzheimer’s. A Pervasive Problem Fraudulent products not only won’t work—they could cause serious injury. In the past few years, FDA laboratories have found more than 100 weight-loss products, illegally marketed as dietary supplements, that contained sibutramine, the active ingredient in the prescription weight-loss drug Meridia. In 2010, Meridia was withdrawn from the U.S. market after studies showed that it was associated with an increased risk of heart attack and stroke. Fraudulent products marketed as drugs or dietary supplements are not the only health scams on the market. FDA found a fraudulent and expensive light therapy device with cure-all claims to treat fungal meningitis, Alzheimer’s, skin cancer, concussions and many other unrelated diseases. Generally, making health claims about a medical device without FDA clearance or approval of the device is illegal. “Health fraud is a pervasive problem,” says Coody, “especially when scammers sell online. It’s difficult to track down the responsible parties. When we do find them and tell them their products are illegal, some will shut down their website. Unfortunately, however, these same products may reappear later on a different website, and sometimes may reappear with a different name.” Tip-Offs Consumers can subscribe to the FDA RSS feed that will send information on fraudulent products to your smart phone or computer and help you from being duped or hurt by these products. To report a health product that you suspect is fraudulent, call your local FDA Consumer Complaint Coordinator. FDA offers some tip-offs to help you identify rip-offs. * One product does it all. Be suspicious of products that claim to cure a wide range of diseases. A New York firm claimed its products marketed as dietary supplements could treat or cure senile dementia, brain atrophy, atherosclerosis, kidney dysfunction, gangrene, depression, osteoarthritis, dysuria, and lung, cervical and prostate cancer. In October 2012, at FDA’s request, U.S. marshals seized these products. * Personal testimonials. Success stories, such as, “It cured my diabetes” or “My tumors are gone,” are easy to make up and are not a substitute for scientific evidence. * Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as, “Lose 30 pounds in 30 days” or “eliminates skin cancer in days.” * “All natural.” Some plants found in nature (such as poisonous mushrooms) can kill when consumed. Moreover, FDA has found numerous products promoted as “all natural” but that contain hidden and dangerously high doses of prescription drug ingredients or even untested active artificial ingredients. 9

* “Miracle cure.” Alarms should go off when you see this claim or others like it such as, “new discovery,” “scientific breakthrough” or “secret ingredient.” If a real cure for a serious disease were discovered, it would be widely reported through the media and prescribed by health professionals—not buried in print ads, TV infomercials or on Internet sites. * Conspiracy theories. Claims like “The pharmaceutical industry and the government are working together to hide information about a miracle cure” are always untrue and unfounded. These statements are used to distract consumers from the obvious, common-sense questions about the so-called miracle cure. Even with these tips, fraudulent health products are not always easy to spot. If you're tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first. Common Types of Health Fraud Scams Cancer, diabetes, and HIV/AIDS fraud: These conditions require individualized treatments by a physician. Relying on unproven products or treatments can be dangerous, and may cause harmful delays in getting the proper diagnosis and appropriate treatments. Arthritis remedies fraud: Symptoms of arthritis tend to come and go so it’s easy to fall prey to socalled “treatments”, such as magnets, copper bracelets, chemicals, special diets, and electronic devices. Some of these products could be harmful, are expensive, and aren’t likely to help. Bogus dietary supplements: Many supplements offer health benefits, but claims to treat or cure diseases are unproven and not allowed by law. Increasingly, so called “dietary supplements” are found to contain hidden illegal drugs and other chemicals that could cause serious harm. This is especially true for weight loss, sexual enhancement, and bodybuilding “supplements.” Weight loss scams: Ads that promise “quick and easy” weight loss without diet or exercise are almost always false. Anti-aging scams: Despite claims about pills or treatments that lead to endless youth, no treatment has been proven to slow or reverse the aging process. Diagnostic tests fraud: Don’t use “medical” tests that are not approved or cleared by the Food and Drug Administration (FDA). They are often used to get you to buy products you don’t need, and give inaccurate and/or useless results. Influenza (flu) remedies fraud: Though they may promise to help you avoid the latest flu or get well faster, there is little or no evidence to support these claims. Sexually transmitted diseases (STDs) fraud: Drug or supplement products are not available over-thecounter (OTC) to prevent, treat, or cure STD’s. They are available only by prescription. Use of bogus STD products may result in inaccurate diagnosis and delayed treatment, increasing the possibility of infecting a sexual partner. How to Report a Problem To report non-emergency problems with an FDA-regulated product, contact the consumer complaint coordinator in your geographic area. For a list of the coordinators and more information on reporting a problem visit: www.fda.gov/Safety/ReportaProblem, or call 1-888-463-6332. To file a complaint with the Federal Trade Commission about misleading ads or websites for health products call 1-877-FTC-HELP (1-877-382-4357).

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Issue #0614

Class A CEU

CEU QUESTIONNAIRE Complete the questions below to receive 10 continuing education credits. All questions must be answered completely to receive credit. 1.

What is the definition of a dietary supplement? ______________________________________________ _______ ____________________________________________________________________________________________

2.

What types of claims cannot be made on dietary supplement labels?______________________________________ ____________________________________________________________________________________________

3.

Why are supplements on the market before October 15th, 1994 not required to be reviewed by the FDA? ________ ____________________________________________________________________________________________

4.

The label of a dietary supplement product is required to be what 2 things? ___________________________ ____________________________________________________________________________________________

5.

Name two of the three types of claims a dietary supplement label may contain. _____________________________ ____________________________________________________________________________________________

6.

Before being allowed to market a drug product, manufacturers must obtain FDA approval by providing what? ____________________________________________________________________________________________

7.

What is a proprietary blend ?_____________________________________________________________________ ____________________________________________________________________________________________

8.

What is the FDA “Good Manufacturing Practices”?__________________________________________________ ____________________________________________________________________________________________

9.

What is a botanical? ___________________________________________________________________________ ____________________________________________________________________________________________

10.

Name 5 forms botanicals can be sold in .___________________________________________________________ ____________________________________________________________________________________________

11.

What is cranberry juice and concentrated cranberry extracts used for? ____________________________________ ____________________________________________________________________________________________ 11

12.

List a possible side effect of saw palmetto?_________________________________________________________ ____________________________________________________________________________________________

13.

What is black cohosh commonly used for and what is a possible adverse effect? ____________________________ ____________________________________________________________________________________________

14.

According to the FDA, when is a health

product fraudulent? ________________________________

____________________________________________________________________________________________

15.

List 4 examples of fraudulent related claims. ________________________________________________________ ____________________________________________________________________________________________

16.

What is the active ingredient in the prescription weight-loss drug Meridia?________________________________ ____________________________________________________________________________________________

17.

What is a structure/function claim? _______________________________________________________________ ____________________________________________________________________________________________

18.

On a dietary supplement label, what 3 things must be listed under general information? ______________________ ____________________________________________________________________________________________

19.

What approaches do scientists

use to evaluate botanical dietary supplements? ___________________

____________________________________________________________________________________________

20.

The safety of a botanical depends on what things? _______________________________________ ____________________________________________________________________________________________

Please mail answer portion only of CEU back to the NAHP. DO NOT FAX IT IN. Any CEUs received via fax will be discarded without credit being awarded. Name ___________________________________________________________ Address ___________________________________________________________ City __________________________ State _______ Zip _____________ Member ID / SSN ______________________________________________________ CEU Update #0614 12

National Association for Health Professionals P.O. Box 459 Gardner, KS 66030

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