Filed under: FDA
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.
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.
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.
The Food and Drug Administration (FDA) is warning consumers about powdered pure caffeine, particularly as sold in bulk on the Internet. At least one death has been associated with the use of such products, and FDA advises consumers about the potency of powdered pure caffeine. See FDA’s Consumer Advice, which includes information about how to report an adverse event.
According to this consumer resource from FDA, you should limit your caffeine intake to just 100–200 mg per day (about 5–10 ounces of coffee). Taking large doses of caffeine—roughly 400–500 mg—at one time can result in a serious condition known as “caffeine intoxication.” Some symptoms of caffeine intoxication are minor and include nausea, vomiting, agitation, nervousness, or headache. Other symptoms can be more life-threatening, such as rapid heartbeat, electrolyte imbalance, very high blood sugar, or high levels of acid in the blood, which can cause seizures. See the OPSS FAQ to help you avoid hidden sources of caffeine.
E-cigarettes were introduced to help people stop smoking, but they are becoming a popular alternative to traditional cigarettes. But are they really a healthier substitute, as many companies claim? In short, we don’t yet have a full answer to this important question, and the U.S. Food and Drug Administration (FDA) is on a mission to find out.
On April 25th, FDA released a proposal for new regulations on e-cigarettes—a multibillion-dollar industry that so far has not been highly regulated. In fact, FDA currently lacks the authority to collect vital information about these products. Traditional cigarettes deliver thousands of chemicals, many of which are dangerous, to cigarette smokers and non-smokers around them. By comparison, e-cigarettes deliver substantially fewer chemicals. However, little is known about the potential dangers of the chemicals that e-cigs deliver.
Proposed new rules would allow FDA to collect information about the ingredients in e-cigarettes, as well as their health and behavioral effects. It also suggests that more research is needed to study the long-term health effects of these products.
E-cigarettes are now being marketed with flavors popular among young people. Preliminary studies have found that young people who say they would never use a tobacco product are experimenting with e-cigarettes. The proposed new rules also would require e-cigarette users to be at least 18 years of age to purchase these products.
Although it’s still unclear how the popularity of e-cigarettes will impact public health, but it’s certain that more research will shed some light on their long-term effects.
We’ve said it before: The Nutrition Facts label on a food package can be a Warfighter’s best friend. But it might be getting a facelift, so to speak, to reflect the latest scientific information, courtesy of the Food and Drug Administration (FDA). The overall “look” of the label will be almost the same, but certain parts will change or be enhanced. Here are some of the proposed changes:
- Serving size: Updated to reflect the way people eat and drink today
- Calories and Servings: Shown in larger type
- Daily Values (DVs): Updated for various nutrients, such as sodium, dietary fiber, and vitamin D
- % DVs: Listed first because it’s easier to read left-to-right
- Added sugars will be shown on a new line.
- DVs for vitamin D and potassium will be included.
- Calories from fat: Going away because according on research, the type of fat is more important than amount. However “Saturated Fat” and “Trans Fat” will remain on the label.
Take a look at the old and new versions side-by-side and then visit HPRC’s Facebook page to tell us what you think of the proposed changes! FDA is seeking comments on the proposed changes, and the closing date has been extended until August 1, 2014, so this is your opportunity to be heard.
Recently, several dietary supplement manufacturers have promoted products for helping with recovery from concussions and traumatic brain injuries (TBIs). The Food and Drug Administration (FDA) is monitoring this issue and is contacting specific companies that are making claims that their products can prevent, treat, or cure concussions.
FDA is warning consumers to avoid using products that claim to treat a concussion or TBI. For more information about the claims and FDA’s response, see this Consumer Update.
In April, FDA announced that the substance was illegal for use as an ingredient in dietary supplements, after which the number of products that contained it rapidly declined.
Only 19 products were added to the list over the past 12 months; none were actually new to the market, but just ones that came to our attention as other products with DMAA became unavailable. By comparison, 46 products were discontinued/reformulated, and 86 DMAA-containing products (or versions of products) appear to have disappeared completely from online retail availability. Only 61 products remain on the “active” list, and many of these are from non-U.S. sources; some still on the list may have eliminated (or are about to eliminate) DMAA, but their manufacturer/distributor websites are unclear as to their status.
HPRC will continue to update its list and report of “Dietary Supplement Products Containing DMAA,” with the most recent version dated December 2014, but updates will appear less often than in the last two years.
The Food and Drug Administration (FDA) has issued warning letters to 15 companies regarding illegally marketed diabetes products that are in violation of federal law. These products are either dietary supplement products or unapproved prescription drugs with claims that they “prevent and treat diabetes” and “can replace medicine in the treatment of diabetes.”
FDA is warning consumers to stop using these products since they may harmful, and their use may interfere with receiving the necessary medical treatment for diabetes. More information is provided in FDA’s “Illegally Sold Diabetes Treatments,” which includes the news release, warning letters issued, and a consumer update.
Cheeba Chews are marketed as chocolate taffy, but they actually contain an illegal substance. Read the Operation Supplement Safety (OPSS) FAQ to find out more about these products and whether they are legal for members of the military community to consume. Be sure to check back often as we add answers to other questions and topics in the OPSS section of HPRC’s website.