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HPRC Fitness Arena: Dietary Supplements
According to a recent article in Stars and Stripes, Military doctors are worried that certain energy supplements could lead to heart problems in U.S. troops, particularly those serving in combat zones.
Click below to access the article.
The FDA held a press conference on 12/15/2010 announcing that it was sending a letter to all dietary supplement trade associations, as well as posting a message to consumers, about the growing problem related to the sale of various misbranded drug products masquerading as "dietary supplements."
A recent systematic review found that nutritional and herbal supplements may be an effective way to treat anxiety and anxiety related problems without serious side effects. Although scientists reported that positive outcomes may be due to a placebo effect*, based on the review, there is scientific evidence to support the use of certain nutritional and herbal supplements to treat these conditions. If you are currently being treated for anxiety, discuss with your physical the option of using or including a natural supplement.
* A placebo effect is the beneficial effect in a patient following a particular treatment that arises from the patient's expectations concerning the treatment rather than from the treatment itself.
The Federal Trade Commission (FTC) recently filed a complaint against POM Wonderful products due to deceptive advertising. POM Wonderful has claimed that its products will reduce (or treat) heart disease, prostate cancer and erectile dysfunction. The FTC says that these claims are not supported by scientific research.
So, what’s a health claim and what’s considered acceptable advertising as such?
A health claim statement has to have a food substance, food, or dietary ingredient, and a health condition or disease. The Food and Drug Administration (FDA) has approved certain health claims that, based on scientific evidence, show a link between a food or supplement and a health condition or disease. Health claims cannot state that a food product or supplement can treat or cure a disease. It may claim to minimize a disease risk; for example, a product advertised as low sodium can state the approved claim that “diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”
Health claims shouldn’t be confused with structure/function claims. These claims do not have to be approved and reviewed by the FDA, yet they must be truthful in stating that a substance maintains structures and/or functions of the body. We see these claims on many fiber-rich products, like “fiber maintains bowel regularity,” or a dairy product stating that “calcium builds strong bones.” Unlike health claims, structure/function claims cannot be linked to a health-related condition or disease. Also, an important point to keep in mind: if a dietary supplement label makes a structure/function claim, it must also state this disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
There are also nutrient content claims. These describe the amount of a nutrient in a product. Descriptions such as free, low, high, and rich in are used, or other terms that describe the nutrient content to that of the content in another product, such as reduced, lite, less, or more.
Manufacturing companies want consumers to buy their products. We, as consumers, must be savvy as we try to choose products that are healthy for our families and us. False health claims are used on food products as well as dietary supplements. They claim to help us lose weight, cure diseases, and prevent memory loss. The FDA has not approved claims that focus on the treatment of diseases. They have, however, set forth regulations to authorize health claims after the scientific evidence has been presented and reviewed.
Protein powder supplements are a popular source for packing on muscle. The September 27, 2010 edition Health section of the L.A. Times contains an article that poses the question of how much supplements, if any, should one use in building muscle mass?
Wandering down the aisle of a store looking for a dietary supplement can be overwhelming and intimidating. There are so many to choose from, and we often have to make our choices based on advertising claims and rely on the manufacturers for ingredient information. Does the supplement actually have the ingredients claimed on the label? Will it have the reported effect on our health?
The Natural Medicines Comprehensive Database is the “scientific gold standard” for evidence-based information on dietary supplements and natural medicines, including drug interactions, effectiveness, safety and use, and more. HPRC has partnered with Natural Medicines Database to allow healthcare providers, Warfighters, and military families to search this comprehensive database in order to make informed decisions about dietary supplement use. The Natural Medicines Database also has “Natural MedWATCH,” which allows users to report an adverse event associated with the use of dietary supplements or natural medicines so that they can then forward the report on to the appropriate regulatory agency.
By going to the HPRC homepage, users can access any of the three database choices provided: Natural Medicines Comprehensive Database for Health Professionals, Consumers, or Natural MedWATCH. After choosing one of the sites, first-time users should sign up for an account, which is done with an active DoD email address. Once inside this vast database, a user can search for an individual natural medicine ingredient of interest or a brand name product.
The professional version of the database includes:
- Evidence-based monographs available for individual natural ingredients.
- Scientific names of ingredients
- Information on safety, effectiveness, mechanism of action, adverse reactions, interactions, and dosage/administration (which are not necessarily recommended or safe doses) of ingredients
- Patient handouts
- Brand-name product searches by ingredient
- “Natural Product Effectiveness Checker” for medical conditions
- “Natural Product Drug Interaction Checker” for a list of drugs/natural products interactions
- Comprehensive information on brand-name products, including ingredient lists and summary reports on effectiveness, interactions, and adverse effects.
- Up-to-date information for over 60,000 brand name products
The consumer version, for military families and Warfighters, contains the same research-based information on herbal remedies, dietary supplements and other natural products, but in an easier-to-understand version. An important point consumers should be aware of is that it may be necessary to research each individual ingredient in a product before making a decision to use it for health benefits.
So, if you want to find credible, evidence-based information on dietary supplements and/or natural products, search the Natural Medicines Comprehensive Database. Evaluating natural health products can be daunting and there is no other comprehensive, reliable site like it to guide you in making your decision.
Despite widespread access to internet-based healthcare information, there’s almost a complete lack of evidence showing any effects all this information may have on health outcomes. According to a study published in Health Expectations, this indicates that there’s a disparity between the health information we find online and our ability to use it properly.
So, with as much information as there is on the internet, how can we, as consumers, find reputable sources for our health questions? The internet can be a great resource when you want to learn about a specific disease or health condition. You can also find tips on staying healthy. But among the millions of websites that offer health-related information, many present myths and half-truths as if they are facts.
To avoid unreliable health information when you’re surfing the internet, use these tips to find reliable information:
- Keep in mind that anyone can publish anything they want on the internet, regardless of the facts. Ultimately, it’s up to the consumer to determine which information source is credible.
- In order to determine a trusted, verified source for credible and objective information, stick with well-respected health websites. A good starting point is healthfinder.gov, which provides a “Health A to Z” topic listing (http://www.healthfinder.gov/HealthAtoZ/ ) of over 1,600 health topics from the most trusted sources.
- Newspapers always use more than one source for verifying factual information. The same should hold true for health information. When searching a topic, it’s important to find at least a second reference to confirm your findings. Find a third reference, too, if possible. When several sources report similar information on a topic, it’s more likely to be accurate and up-to-date. In general, if you can't find the information duplicated in more than two or three references, then the information is questionable at best.
- Become skilled at separating facts from opinions. This can sometimes be difficult, as the evidence that exists may be minimal. It's important that you know the difference between fact and opinion, especially when you're researching treatment alternatives.
- Testimonials and personal stories tend to focus on a patient’s subjective point of view. If you find a website that quotes patients about the effectiveness of a treatment or therapy, this information is biased and cannot be trusted as a reliable source. However, there is information to be learned from the experiences of patients by using other sources (for example, through blogs and wikis, and support group message board forums). In those situations, refer back to point 1 (above) as your first line of review.
- Make sure the information you find is the most current available. Often, you will find that research and studies conflict with one another, or that newer information trumps older information.
Finally, information that you find on a website does not replace your doctor's advice. Your doctor is the best person to answer questions about your personal health. If you read something on the internet that doesn't concur with what your doctor has told you, make a point to speak with him or her about it.
In a report from the September 2010 issue of Consumer Reports®, the twelve most dangerous dietary supplements posing health risks have been identified. According to the report, these are dietary supplements which are taken by millions of Americans and have been found to cause serious health problems, including cardiovascular, liver, and kidney problems.
When you choose a multivitamin or supplement from the store, have you ever wondered how to choose? Or if there’s any regulation to ensure the one you choose is safe, and that you’re getting what you’re paying for? Regulation is perhaps the least understood aspect of the dietary supplement industry. We, here at HPRC, hope we can shed some light on the matter. Look for the quickest way to ensure quality and safety in your supplements at the end of the article.
Dietary supplements are regulated, but not as strictly as many might want. Oversight of dietary supplements began with the 1994 Dietary Supplement Health and Education Act (DSHEA). Since supplements are intended to supplement one’s diet, they are regulated the way food is, and not as drugs are. Under DSHEA, the U.S. Food and Drug Administration (FDA) regulates dietary supplements by holding manufacturers accountable in five important areas: Manufacturers are required to ensure that the supplement is safe; make truthful claims; abide by current Good Manufacturing Practices (cGMPs); submit to FDA all reports of serious adverse events, and notify FDA before it markets a supplement containing a “new dietary ingredient” (NDI).
What consumers should know is that manufacturers cannot sell unsafe, ineffective supplements; they have to document that their product will not harm anyone, and provide convincing evidence that the product does what it claims. To further ensure safety and effectiveness, the FDA closely regulates supplement labels for accuracy and honesty. All information on the label must be truthful and conform to all FDA standards. It has to list the sources of all components, and the amount of key nutrients and ingredients. Manufacturers are also required to report to the FDA before marketing supplements containing new dietary ingredients, which must have data supporting safety of the ingredient. The FDA also regulates manufacturing standards using the current Good Manufacturing Practices (cGMP) to ensure product quality and safety. Violation of cGMP is a violation of the law. Lastly, the FDA requires manufacturers to report on serious adverse events that may occur from consumers using their products.
Despite this oversight, there’s a misconception that dietary supplements are not regulated. This could be because supplements don’t require pre-market approval, and the post-market responsibility of FDA simply ensures compliance with the regulations listed above. The downside of this is that some unsafe and contaminated products end up on the market. Once there, the FDA has to prove that the product is unsafe (or show that the information on its label is untruthful or misleading), before it can be removed from the market. Also, although supplement labels are highly regulated, the content of separate brochures and fliers is not subject to FDA rules.
Enforcing regulations take time and resources. Since the cGMP rule went into effect in June 2008, the FDA has conducted approximately 55 inspections for compliance with the new regulations – and in light of the thousands of companies manufacturing supplements, there’s some dissatisfaction with the progress of the FDA.
So how can you protect yourself, as a consumer, from ineffective or even potentially unsafe supplements? There’s a simple answer: When purchasing dietary supplements, choose products approved by independent organizations that offer certification or verification. Look for supplements whose labels display a seal from the United States Pharmacopeia (USP), the non-profit NSF International, or the Natural Products Association (NPA). Since these verifications are voluntary and are performed at the company’s expense, you can be certain that approved products have little or no contaminants, that the ingredients are present in the labeled amounts, and the labels are accurate.
The June 29 edition of the Telegraph.co.uk published an article titled Caffeine can boost endurance racing. The article cites research done by Coventry University and reports that high doses of caffeine can increase muscle power and endurance.
Study author Dr Rob James, from the University of Coventry's Department of Biomolecular and Sports Science, said: "A very high dosage of caffeine, most likely achieved via tablets, powder or a concentrated liquid, is feasible and might prove attractive to a number of athletes wishing to improve their athletic performance.
"A small increase in performance via caffeine could mean the difference between a gold medal in the Olympics and an also-ran."