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HPRC Fitness Arena: Dietary Supplements
Lazy Cakes Relaxation Brownies claim to “have relaxation built into every bite.” One brownie (half is the recommended serving size) contains 3 mg of melatonin, a hormone made by the body but also available as a supplement that is often used to treat sleep disorders and jet lag. Selling these brownies as a dietary supplement allows the manufacturer to avoid FDA regulation for foods and beverages. The label warns consumers not to drive or operate heavy machinery and to consult your physician if you are taking medication or are pregnant or nursing; it also says the product is recommended for adults only. Buyers beware…this is no typical brownie.
We’ve seen all the recent news and reports about energy drinks and the concern about the amount of caffeine in these products. Now a new wave of products is gaining attention, aimed at helping us relax, reducing our anxiety, and helping us sleep. These “relaxation beverages,” or “anti-energy drinks,” contain ingredients such as melatonin, valerian root, kava, St. John’s Wort, L-theanine, rose hips, and chamomile. A great number of relaxation beverages have been introduced into the market over the last three years, with names such as “Dream Water,” “iChill,” “Vacation in a Bottle,” and “Unwind.” Consumers of any age can buy these drinks in convenience stores, college campuses, and online.
Part of the problem with these relaxation drinks is that some of their ingredients, particularly melatonin, have not gone through the Food and Drug Administration’s (FDA) approval process required for all food ingredients to be designated as safe or GRAS (“generally recognized as safe”). Melatonin is a hormone made by the body, but it is also available as a supplement and is often used to treat sleep disorders and jet lag. The FDA sent a warning letter last year to the manufacturers of the “Drank” beverage saying, “there is no food additive regulation in effect that provides for the safe use of melatonin…Likewise, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.” The manufacturers of “Drank” want their product to be classified as a dietary supplement, not as a beverage, since the FDA scrutinizes foods and beverages much more closely than dietary supplements.
People who have liver problems, liver disease, or are taking prescription drugs should be cautious about using the herb kava, an ingredient found in some of these relaxation drinks. Kava has been linked to severe liver injury, and the FDA issued a consumer advisory in 2002 with a warning that kava-containing dietary supplement products have been associated with liver-related injuries, including hepatitis, cirrhosis, and liver failure. Valerian root, a medicinal herb, is used to treat sleep disorders as well as anxiety. Although some research has been conducted on the effects of valerian on insomnia, the data are mixed, and no studies have tested the safety and effectiveness of the combination of ingredients found in relaxation beverages.
The marketing of relaxation drinks is also of concern, as it is geared toward a younger crowd, with bottles resembling the look of popular energy drinks and shots. The concern is that young adults will think nothing of having more than one of these a day. Some of these beverages have warnings on their labels stating that users should not consume them before operating/driving machinery or if pregnant or nursing.
What’s the bottom line? Buyers beware! There’s no magic pill, and there’s no magic beverage. Try to determine the causes of your stress and/or insomnia, address those issues, and then work towards establishing a healthy lifestyle overall.
Godi International, Corp., located in South Florida is announcing a recall of Fruta Planta weight loss dietary supplements because the products contain Sibutramine an undeclared drug ingredient. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Click below to access the recall alert.
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.
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.
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.