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HPRC Fitness Arena: Dietary Supplements

Redotex for weight loss?

Is the weight-loss product Redotex legal?

Redotex is a drug manufactured in Mexico and being sold in the U.S. as a weight-loss product. According to the U.S. Food and Drug Administration (FDA) it is a misbranded drug and is not legal to sell as either a drug or a dietary supplement. It is not permitted for use by DoD personnel or civilians.

According to the FDA Import Alert, “it appears to be a new drug without an approved New Drug Application…” In addition, it contains a combination of thyroid, diuretic, stimulant, and tranquilizer drugs that may cause serious and potentially fatal adverse reactions. In addition to posing a health hazard, the product contains a DEA Controlled Substance that will cause a positive drug test. It is very important to read product labels, and if the label is not in English or contains any of the drug ingredients listed in the FDA Alert, steer clear, as it is an illegal product.

For more answers to questions we’ve received about weight-loss dietary supplements, please visit our Operation Supplement Safety (OPSS) FAQs.

FDA warns about BMPEA

What is BMPEA and why has FDA issued a warning about it?

BMPEA is an unapproved amphetamine-like substance that has been appearing in some dietary supplement products. BMPEA (also known as β-methylphenylethylamine, R-beta methylphenylethylamine, beta-methylphenethylamine, and others) was first made in the 1930s as a possible replacement to amphetamine (a central nervous system stimulant), although it never became a drug because human studies on safety were not performed.

The Food and Drug Administration (FDA) tested 21 supplement products with the ingredient Acacia rigidula listed on the label and found that 9 of the 21 products were found to contain BMPEA, which is not derived from the plant Acacia rigidula. Some dietary supplement products actually list BMPEA on their labels. FDA recently issued a warning stating, “…BMPEA does not meet the statutory definition of a dietary ingredient.” Therefore, dietary supplement products with BMPEA are misbranded and cannot be sold as dietary supplements.

The World Anti-Doping Agency has banned BMPEA. For more answers to questions we’ve received about ingredients in dietary supplements, please visit our Operation Supplement Safety (OPSS) FAQs.

Deadly DNP in supplements

You may have read about deaths associated with weight-loss supplements containing DNP. What is it? Is it really all that dangerous?

DNP stands for “2,4-dinitrophenol,” an industrial chemical used in diet pills in the early 20th century that is now resurfacing. Over the past several years, deaths associated with DNP in weight-loss products have been reported.

A century ago DNP was recognized as dangerous and often deadly. In fact, the first Federal Food, Drug, and Cosmetic Act in 1938 made it illegal in oral products, describing it as “extremely dangerous and not fit for human consumption.” However, it is still made for pesticides and other industrial uses.

Virtually anyone can purchase the chemical and put it into a product. It is currently being marketed on the Internet as a weight-loss product. It takes very little for a lethal oral dose (as low as 4.3 mg/kg bodyweight, or about 350mg for a 180 lb person), and even skin or respiratory exposure can be toxic. DNP leads to dehydration from sweating, severely high body temperature, and cell poisoning, resulting in organ failure. There is no specific antidote for DNP poisoning, and treatment is often unsuccessful.

If you see “DNP” or “dinitrophenol” on a product label, steer clear! DNP supplements are marketed almost exclusively online, so be careful what you buy.

For more answers to common questions we’ve received about dietary supplements, please visit our Operation Supplement Safety (OPSS) FAQs.

Can you spice up your weight loss?

Capsaicin gives certain foods their spiciness. It’s also being sold as a dietary supplement. But will it help you lose weight? Read more in the latest OPSS FAQ.

If you’ve ever eaten something spicy and felt a burning sensation on your tongue, then you’ve eaten capsaicin. Capsaicin is the substance found in chili peppers such as jalapeños, serranos, and habaneros that gives them their spiciness. Although humans have been eating peppers for thousands of years, capsaicin has only recently come into the supplement spotlight. As an isolated ingredient, it is usually sold as capsules labeled “cayenne pepper” or “capsicum” after the family of peppers that naturally contain capsaicin.

Capsaicin supplements are marketed to aid with weight loss in three ways: increase energy use, burn fat, and decrease appetite. Some scientific evidence supports these statements, but the results of most studies were inconsistent, short-lived, and didn’t always result in weight loss. Long-term effects of taking capsaicin supplements, especially at high doses, are still unknown, so their safety over time needs further investigation.

Although capsaicin is considered safe to consume in food, capsaicin supplements can cause gastrointestinal issues (gas, stomach pain, and diarrhea) for some people. They also can interact with certain medications and other herbal supplements, so you should consult a healthcare provider before taking it. Capsaicin supplements also may not be safe if you are allergic to peppers or if you‘re pregnant or lactating.

Visit Operation Supplement Safety for more OPSS FAQs about weight loss.

What is bitter orange?

Bitter orange, synephrine, and octopamine are three ingredients I’ve seen a lot on Supplement Facts panels and labels. What are they?

Bitter orange is an extract from the immature green fruit of the Citrus aurantium plant, also known as Seville orange. It is sometimes used in small amounts in food as a flavorant and often used in weight-loss supplements. The terms “bitter orange,” “bitter orange extract,” or “Citrus aurantium” are often used interchangeably with the ingredient name “synephrine,” but bitter orange (the extract from Citrus aurantium fruit) is actually a complex mixture of many compounds, including synephrine and octopamine. Although both synephrine and octopamine occur naturally in the Citrus aurantium plant, they also can be made in a laboratory.

Many safety concerns have been raised with regard to synephrine and octopamine, which are both stimulants. The National Collegiate Athletic Association (NCAA) bans both of them, but the World Anti-Doping Agency (WADA) bans only octopamine. Bitter orange is frequently used in "ephedra-free" products since 2004, when the Food and Drug Administration (FDA) banned ephedra for its association with serious adverse cardiovascular effects. Combinations of stimulants—such as bitter orange and caffeine, commonly found together in weight-loss and bodybuilding products—can cause hypertension and increase heart rate in otherwise healthy adults. A major concern with products that list bitter orange (or synephrine, or octopamine) on the label is that the amount of stimulants in the product is sometimes very difficult—if not impossible—to determine. Service members should exercise extreme caution when considering whether to use supplements containing bitter orange.

No conclusive, peer-reviewed, scientific evidence clearly establishes that bitter orange is any safer than ephedra. For more information on bitter orange and ephedra, read the monographs in HPRC’s Dietary Supplement Classification System series.

For more answers to common questions we’ve received about dietary supplements, please visit our Operation Supplement Safety (OPSS) FAQs.

Lucky number 7? Omega-7s and your health

Your body makes omega-7 fatty acids, but will getting more from supplements be beneficial? Check out the new OPSS FAQ.

What are omega-7 fatty acids? And do omega-7 supplements convey the health benefits advertised?

Omega-7 fatty acids are a type of unsaturated fat. Omega-7s are considered non-essential fatty acids, which means your body can make enough omega-7s to function properly. In other words, you don’t need to get them from foods or supplements.

One of the most common forms of omega-7s, which is also used in supplements, is palmitoleic acid (not to be confused with palmitic acid, which is a saturated fat). Omega-7 supplements are marketed for health benefits such as heart and liver health, improved cholesterol levels, weight loss, glucose (blood sugar) metabolism, and immune support. Limited research has shown some benefits from palmitoleic acid supplementation, but most of the research has been done on animals and only for short test periods (less than four weeks). As a result, no recommended dose or source of palmitoleic acid exists, and there is not enough evidence to suggest that omega-7 supplements can improve heart health or health in general.

Weight-loss promises

FDA warns against weight-loss products that don’t live up to their claims.

With New Year’s resolutions upon us, weight loss is often at the top of the list for many. However, before you consider a dietary supplement to help your weight-loss goals, be aware of the Food and Drug Administration (FDA) warnings that these products don’t live up to their claims. Even worse, some can result in serious harm.

Many dietary supplement products marketed for weight loss have been found to contain hidden prescription drugs or compounds that have not been adequately studied in humans. FDA continues to identify “tainted” products and warns consumers to stay away from these tainted products. You can read more about this in FDA’s consumer-health article Beware of Products Promising Miracle Weight Loss and watch their video. Also, be sure to check out the Operation Supplement Safety (OPSS) FAQs about Weight Loss for additional information on weight loss and dietary supplements.

Products claiming to prevent or treat Ebola

Avoid dietary supplement products claiming to prevent or treat Ebola.

At this time, the Food and Drug Administration (FDA) has not yet approved any vaccines or drugs for the prevention or treatment of Ebola. However, online advertising of some dietary supplement products makes claims that they can prevent or cure this deadly infectious disease.

By definition, a dietary supplement product cannot make a claim that it will prevent or cure a disease. FDA advises consumers to be aware that these products are fraudulent and should not be used. You can read more about these products and about Ebola in FDA’s Press Announcement. And be sure to visit the Operation Supplement Safety (OPSS) website to learn more about dietary supplements in general and how to choose supplements wisely.

DMAA: Lingering products and new developments

HPRC’s updated list of products with DMAA for December 2014 is now online. But read on for information about “replacement” ingredients and related concerns.

1,3 dimethylamylamine (DMAA) is slowly disappearing from the U.S. market, but we decided to update our list of “Products containing DMAA” once more. As you will see from the list, it continues to shorten, but there are still some companies—including a few in the U.S.—that continue to manufacture or distribute dietary supplement products that contain this now-illegal ingredient. In addition, there are still many discontinued products that remain for sale from retail stock.

In examining the ingredients lists for reformulated products that used to contain DMAA, however, we have seen some reasons for continued concern. One of these is the replacement of DMAA with ingredients that may have equal potential for health risks. Among these are DMBA, SARMs, and synephrine. For more about stimulants, you can visit our new OPSS FAQs on how to identify stimulants on a label and why stimulants are potentially problematic.

Is there a list of dietary supplements/substances banned by the military?

There is no banned dietary supplement list in the military, but you can learn how to make informed decisions about dietary supplement use.

Lately, HPRC has been receiving a lot of questions about the use of banned supplements in the military, but the fact is: There isn’t a list of banned dietary supplements currently available. It isn’t always easy to determine whether a dietary supplement product is safe or not, so the Department of Defense (DoD), together with HPRC, provides helpful resources on the Operation Supplement Safety (OPSS) website to help you choose supplements wisely. With regard to the military’s stance on supplements in general, please see the OPSS FAQ about a "banned list," which is pertinent to all service branches.

Some dietary supplements, including ones sold on military installations, contain potentially harmful and problematic ingredients. For some tips about how to avoid these, read the OPSS infosheet “Red Flags—What You Need to Know.” In addition, some other potentially dangerous ingredients include prescription drug ingredients and their analogs, drugs banned by FDA for safety reasons, controlled substances (such as anabolic steroids), and untested/unstudied new active drug ingredients, which may not be listed on the product label.

One way to ensure that a dietary supplement product is safe is to see if it is third-party verified. Third-party certification organizations have developed criteria for evaluating and authenticating the quality of a supplement—the ingredients, the dosage levels, the level of contaminants, the label claims, and whether the manufacturing facilities follow Good Manufacturing Practices (GMP).

The Natural Medicines Comprehensive Database (NMCD) is the gold standard for evidence-based information on dietary supplement products and ingredients and is an HPRC partner. (Subscription is free if you have a “.mil” email address; visit the OPSS FAQ for more information.) NMCD rates products on a scale of 1 to 10 based on safety and effectiveness. We encourage you to consider only using products rated 8 or above.

To avoid potential problems, talk with your healthcare provider or dietitian before using dietary supplements. Also, see FDA’s list of tainted bodybuilding products, which includes important public notifications.

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