You are here: Home / HPRC Blog

Filed under: Supplements

What are high-risk supplements?

HPRC Fitness Arena: Dietary Supplements
Some dietary supplement products contain problematic ingredients. Find out which ones might pose a health risk.

High-risk dietary supplements are those that may present serious health risks. Many have been found to contain undeclared drug ingredients, steroids, steroid-like ingredients, and/or stimulants, which can have negative and dangerous side effects. Products most commonly “tainted” in this way are those marketed for bodybuilding, performance enhancement, weight loss, sexual enhancement, and diabetes. Such products may also result in a positive drug test. For more information, read the FDA News Release “Tainted products marketed as dietary supplements potentially dangerous.” For more information about urinalysis and drug testing, read HPRC’sDietary supplements and drug testing."

In addition, you can visit the OPSS High-Risk Supplement List for information about certain dietary supplements that may pose a health or sport anti-doping risk.

For more Frequently Asked Questions about dietary supplements, visit the Operation Supplement Safety (OPSS) FAQs.

The dirt on diatomaceous earth

Diatomaceous earth is promoted as a “cure-all,” but is there any truth behind the claims?

Diatomaceous earth (DE) is a powder composed of fossilized algae called “diatoms.” Diatoms are single-celled organisms found in bodies of water, and DE is used commonly for various reasons: 1) a natural insecticide; 2) an anti-caking agent; and 3) a clarifier for wine and beer. However, some people add food grade DE to their food and beverages because DE is a rich source of silicon dioxide. Silicon is a chemical element that occurs naturally as silicon dioxide in many foods, such as whole grains and vegetables.

Proponents of DE suggest that the high silicon dioxide content helps with weight loss, detoxification/cleansing, energy levels, joint pain, teeth and gums, cholesterol and blood pressure, and food absorption. Consumers and some retailers of DE supplements also claim that its abrasive (scratchy/rough) and absorptive properties improve digestive health by ridding the intestines of bacteria and parasites as well as regulating bowel movements.

There is not enough research to support these claims, and the biological role of silicon in humans is uncertain, so there is no recommended intake or DRI (Dietary Reference Intake). According to Natural Medicines Comprehensive Database, silicon is safe to consume in amounts commonly found in foods, but insufficient scientific evidence is available for its effectiveness and safety as a dietary supplement.

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

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.

Hemp products: Are they allowed?

Find out if service members are allowed to consume products made with some form of hemp.

Hemp, or Cannabis sativa, is the plant that naturally contains the substance tetrahydrocannabinol (THC, the psychoactive ingredient in marijuana) although the chemical can also be produced in a laboratory. Historically, the hemp plant has been used for fiber in clothing, rope, paper, etc., as well as for nutritional, medicinal, and recreational purposes.

According to a 2015 report on hemp prepared for Congress, different varieties (and parts) of the cannabis plant are grown and used for different purposes. “Industrial hemp”—the kind grown for agricultural crops (including in foods, beverages, and dietary supplements)—is typically less than 1% THC. Cannabis grown to produce marijuana usually contains around 10% (but can exceed 30%) THC in the parts of the plant used.

DoD policy as set in DoDI 1010.01 specifically mentions marijuana, “synthetic cannabinoids,” and controlled substances (which include THC), but does not mention hemp per se, and test levels for THC are described in DoDI 1010.16. However, each military service has its own policy on the use of hemp products:

  • Air Force: AFI 90-507, section 1.1.6, states that “the ingestion of products containing or products derived from hemp seed or hemp seed oil is prohibited.”
  • Army: Army Substance Abuse Program, AR600-85, section 4-2p states “this regulation prohibits Soldiers from using Hemp or products containing Hemp oil.”
  • Navy: OPNAVINST 5350.4d, Drug Testing Program, Enclosure (2), states that the “Navy has ‘zero tolerance’ for...the wrongful use, possession, manufacture, or distribution of a controlled substance,” which includes marijuana and THC. The Navy does not have a formal policy on the use of hemp products in food.
  • Coast Guard: ALCOAST 026/99 and COMDTINST M1000.10, section 3.A, state that “ingestion of hemp oil or products made with hemp oil is misconduct that will not be tolerated in the Coast Guard.”

Currently, hemp seeds are being added to a variety of foods (such as yogurt, energy bars, etc.), and based on service policies, such products are prohibited.

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

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.

Can supplements boost your T?

Are testosterone booster dietary supplement products safe and effective?

Testosterone booster dietary supplement products can contain ingredients such as Tribulus terrestris, Eurycoma longifolia (Tongkat Ali or Longjack), maca, yohimbe, arginine, and epimedium (horny goat weed). They claim to increase male sexual hormones such as testosterone, which affect muscle strength, endurance, and male sexual performance, but there is insufficient evidence to support this claim. Testosterone-booster dietary supplements are not drugs and should not contain drugs, but they fall in the class of high-risk dietary supplements, and FDA has found that they often contain undeclared drug ingredients, anabolic steroids, or “designer steroids” that are illegal.

Visit the Operation Supplement Safety (OPSS) FAQs for more questions and answers about dietary supplements. You can also visit the OPSS High-Risk Supplement List for information about certain dietary supplements that may pose health or sport anti-doping risks.

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.

RSS Feed