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Dietary supplements: Questions and answers

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The Food and Drug Administration (FDA) answers consumers' questions about dietary supplements and the regulations of dietary supplements.

The U.S. Food and Drug Administration (FDA) has information for consumers regarding dietary supplements: Questions and answers, regulations, and safety alerts. Click here for their website.

Lazy Cakes: Brownies – or something else?

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With added melatonin to help you relax, this is no typical brownie.

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.

Relaxation beverages: Don’t believe the hype

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A new wave of beverage products is gaining attention, aimed at helping us relax, reducing our anxiety, and helping us sleep.

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.

Nutritional and herbal supplements may help anxiety-related conditions

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A recent review found nutritional and herbal supplements may help treat anxiety and related problems without serious side effects. Scientists report the positive outcomes may be a placebo effect, but positive outcomes are still positive.

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.

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FDA and supplements

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Read on to learn more about how to choose dietary supplements.

The FDA does not strictly regulate dietary supplements. As a result, supplements may not be as pure as stated on the label and may have potentially harmful contaminants. When purchasing dietary supplements, choose products approved by United States Pharmacopeia (USP) or other reputable sources.

For more information, click here for the FDA's information on dietary supplements.

The FDA's consumer information on dietary supplements.

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Supplements and medications

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Dietary supplements may interact with medications or other dietary supplements, and may even contain ingredients not listed on the label. To help ensure coordinated and safe use, inform your health care provider about any dietary supplements you are using.

"Using Dietary Supplements Wisely," from the National Center for Complementary and Alternative Medicine.

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Supplements alone will not reduce your disease risk

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There's no replacement for a healthy lifestyle–a sound diet and regular physical activity.

Remember, taking dietary supplements alone will not reduce your disease risk. You must engage in complementary behaviors such as healthy eating and regular physical activity. Visit the "Dietary Guidelines for Americans" publication for more information.

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