Filed under: Dietary supplements
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.
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.
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.
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.
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.
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.
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.
Some dietary supplement products contain illegal ingredients, but they still can be found in stores and on the Internet. One example of this is the presence of SARMs, or “selective androgen receptor modulators,” in products typically advertised to have effects similar to anabolic steroids. These ingredients, used in dietary supplements, are not legal and should be avoided.
Read the new Operation Supplement Safety (OPSS) FAQ about SARMs to learn more, including how to identify ingredient names for SARMs that may appear on dietary supplement labels. And remember: FDA does not approve dietary supplements prior to marketing. For more information on FDA’s role with regard to dietary supplements, visit FDA Basics.
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.
In a new Operation Supplement Safety (OPSS) PSA video, Gold Star mother Ms. Terri Bellamy-Coleman urges service members to seek out information and guidance on dietary supplements from the appropriate sources before taking them. Ms. Bellamy-Coleman’s son, who was attending the NCO (Noncommissioned Officer Academy, WLC (Warrior Leadership Course) in Fort Benning, GA at the time of his death, had been taking dietary supplements when he exerted himself during physical training, suffered a heart arrhythmia, and died. He had the sickle-cell trait, which may have aggravated the situation. She wants others to be aware of the possible risks associated with dietary supplements, especially when certain medical conditions are present, and urges service members to seek information to help prevent possible harmful health effects. Please watch the video, “A Mother’s Plea."