Filed under: FDA
Dietary supplements don’t require approval by the Food and Drug Administration (FDA) before being put on the market. That means unless a product has been tested in a laboratory, there’s no way to know its true contents, including potentially problematic ingredients and possibly even ones not listed on the label. So how can you tell if a product really contains what it says on the Supplement Facts panel? Check the product label to see if it carries a seal from an independent, third-party organization. For more information and examples of third-party organizations, visit the OPSS FAQ about third-party certification.
Since July 2016, the Food and Drug Administration (FDA) has released over 25 Public Notifications about individual supplement products marketed for sexual enhancement and weight loss that contain hidden active ingredients. Through laboratory testing, these products were found to contain drugs and controlled substances—ingredients that pose health and readiness risks. For a list of these Public Notifications, visit FDA’s Tainted Sexual Enhancement Products and Tainted Weight Loss Products.
The most common types of products found to contain “undeclared” ingredients (that is, substances not listed on the label) are those marketed for weight loss, sexual enhancement, and bodybuilding. Dietary supplements don’t require FDA approval before being put on the market, and there is no way to know the contents of a product without laboratory testing. So if you’re considering a dietary supplement, check the label to see if the product has been evaluated by an independent third-party organization.
In recent years, the Food and Drug Administration (FDA) has taken action against dietary supplement companies for selling products with ingredients that put them in a category of being “adulterated” or “misbranded.” Examples of these ingredients include Acacia rigidula, BMPEA, DMAA, DMBA, ephedra, methylsynephrine, and picamilon. Such ingredients have been determined to be unsafe, lack evidence of safety, don’t meet the definition of a dietary ingredient, or combinations of these issues. Some are even used as drugs in other countries.
Although these ingredients are not allowed in dietary supplements, you might still find them in some products, so always read product labels carefully. Service members especially take note! Since FDA has declared the ingredients listed above (and others) to be “illegal” or “not allowed” in dietary supplements for one reason or another, commands have restricted their use by military members. For more information about FDA’s role in regulating dietary supplement products and ingredients, visit FDA’s web page.
Another ingredient that has been showing up in dietary supplement products recently is Acadia rigidula. FDA recently declared that it is not acceptable in such products because it falls in the class known as a “new dietary ingredient.” A. rigidula is just the latest in a series of ingredients FDA has disallowed for this reason. Others include DMAA, DMBA, BMPEA, and aegeline. Visit the Operation Supplement Safety (OPSS) FAQ about Acacia rigidula to learn more, and explore the OPSS FAQs about ingredients to learn about others not permitted in dietary supplement products. especially BMPEA, which has been associated with A. rigidula.
HPRC has often posted information about 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 FTC’s primary missions 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 made by dietary supplement manufacturers and distributors must be substantiated before they are made. Unfortunately, not all supplement manufacturers follow the rules, so check out FTC’s new infographic to learn more about deciphering dietary supplement claims.
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 information about how to report a problem, visit this FTC web page.
Dietary supplements that claim to be “all natural” aren’t necessarily safe. The Food and Drug Administration (FDA) has issued 2 Consumer Updates warning consumers about “all natural” products for erectile dysfunction and imported dietary supplements.
According to FDA, supplements marketed as “all natural” sexual-enhancement products might be tainted with hidden drug ingredients. Some of these are the same active ingredients found in prescription drugs used to treat erectile dysfunction. Not only could you potentially be consuming multiple drug ingredients, you could be consuming them in amounts even greater than prescription doses. Either way, these types of products can put your health and career in danger. For more information, please read FDA’s Consumer Update on "'All Natural' Alternatives..."
Consumers should also beware of dietary supplements and nonprescription drugs marketed as “all natural” remedies for serious conditions such as cancer, HIV/AIDS, diabetes, or heart disease. “Natural” does not necessarily mean safe, and these products also can contain undisclosed chemicals or drug ingredients that can be harmful. FDA specifically warns consumers about imported products sold online or at flea markets, or swap meets. Please read FDA’s Consumer Update on "Some Imported Dietary Supplements..." to learn more.
The Food and Drug Administration (FDA) is again warning about the dangers of powdered pure caffeine. At least 2 deaths (both teenagers) were associated with it in 2014, yet it continues to be sold, primarily in bulk online. FDA recently sent warning letters to 5 distributors of pure powdered caffeine, warning about potential serious health effects. FDA notes that it’s difficult to determine the difference between a safe amount and a toxic amount but that one teaspoon is roughly equivalent to 28 cups of coffee. For more information, read FDA’s update and HPRC’s 2014 article.
Dietary supplements and medications (prescription or over-the-counter) can be a dangerous combination. Many dietary supplement ingredients, especially herbs and botanicals, can interact with drugs or even other dietary supplements, which can either increase or decrease the effectiveness of your medications. In other words, you could be getting too much or too little of the medications that you need, putting your health at risk.
If you are taking or plan on taking a dietary supplement, inform your healthcare provider to make sure it’s safe to use with your medications. Even then, you should still take caution, as some dietary supplements contain ingredients not listed on the label.
The Food and Drug Administration (FDA) advises consumers to be aware of certain supplement/drug interactions and offers tips to stay safe. For more information, see the FDA’s Consumer Update. And for information about many known interactions, visit the Natural Medicines Comprehensive Database (NMCD).
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.
Food and color additives exist in many of the foods that we eat. They are used to improve safety and freshness, maintain the nutritional value of foods, and improve texture and appearance. The Food and Drug Administration (FDA) has put together a helpful brochure reviewing how additives are approved for foods, types of food ingredients, and a description of food and color additives.