You are here: Home / HPRC Blog

Filed under: 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.

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.

Will nootropics help my brain?

If you’re looking for cognitive enhancers or “smart drugs,” you may want to think twice. Here’s the latest OPSS FAQ.

Nootropics—also referred to as “cognitive enhancers,” “smart drugs,” or “memory enhancers”—are substances intended to improve mental performance. They include drugs used to treat a variety of conditions that affect mental performance such as Alzheimer’s disease, dementia, epilepsy, schizophrenia, stroke, aging, and attention deficit hyperactivity disorder (ADHD). For example, drugs in the racetam family—such as piracetam, aniracetam, oxiracetam, and pramiracetam —are considered nootropics. Some nootropics are marketed for use as dietary supplements to enhance the mental performance of healthy humans.

Nootropic products that contain any “racetam” or similar drugs are not legal dietary supplements as defined by the Food and Drug Administration (FDA), although many also contain vitamins and other natural or synthetic dietary supplement ingredients. In the U.S., piracetam, aniracetam, pramiracetam, and oxiracetam are currently neither controlled substances nor FDA-approved drugs. FDA has issued statements indicating that piracetam-containing “dietary supplement” products do not fit the legal definition of a dietary supplement, since “racetams” do not occur naturally and are not derivatives of any natural substance.

Although scientific study of nootropics is ongoing, there isn’t enough reliable information available to say with confidence whether any specific nootropic agents are safe or effective.  Studies that have examined the effects of these compounds on the mental performance of healthy humans have yielded mixed results, so further study is needed. In the absence of reliable research, we generally suggest extreme caution.

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

Truth in advertising?

Does your dietary supplement’s advertising promise more than the product can actually deliver?

HPRC has often posted information about the U.S. Food and Drug Administration (FDA) and safety surrounding the topic of dietary supplements. But there’s another Federal agency watchdogging the supplements industry: the Federal Trade Commission (FTC). One of the primary missions of FTC is to protect consumers from unfair or deceptive business practices. That includes misleading or false advertising and claims. FTC advertising law states that all claims by dietary supplement manufacturers and distributors must be substantiated before they are made. So far in 2014 alone, FTC has issued press releases regarding unsatisfactory practices by dietary supplement companies. Most recently, one marketer admitted to wrongfully marketing weight-loss benefits of green coffee beans through appearances on television talk shows. Please see the FTC press release for more information.

Just as FDA has a reporting system for adverse effects associated with dietary supplements, FTC has a consumer complaint process that you can use. For this and other consumer information related to dietary supplements, visit this FTC web page.


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.

RSS Feed