U.S. Marshals seized more than 300,000 containers of dietary supplements from Life Rising Corporation in June 2019 at the request of the FDA. The seized goods included tablets, capsules, and teas. The brand names for some of the 500 products are Life Rising, Holicare, or HopeStream. The U.S. District Court for the Northern District of Illinois found that there was probable cause that "the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements," according to the FDA news release. The FDA issued an Administrative Detention Order in May 2019 to prevent these products from reaching consumers until they could be seized based on these violations. Melinda K. … [Read more...]
FDA Goes After Dietary Supplements That Claim Alzheimer’s Treatment
The FDA is taking action against 17 companies for illegally selling dietary supplement products that claim to treat or cure Alzheimer's disease. The agency posted 12 warning letters and 5 online advisory letters to those corporations. The companies are illegally selling more than 58 products, many sold as dietary supplements, that are unapproved new drugs or misbranded drugs. These products have not been reviewed by the FDA and are not proven safe and effective to treat these diseases and health conditions. In fact, these products could be unsafe and could prevent a patient from seeking proper treatment. FDA Commissioner Dr. Scott Gottlieb said in a statement, "Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical … [Read more...]
Supplement Makers Warned by FDA About Tianeptine in Dietary Supplements
The FDA is warning two companies for illegal marketing of dietary supplements that contain tianeptine. One of the warning letters was sent to MA Labs LLC, for Vicaine, and the other was sent to Jack B Goods Outlet Store, for Tianaa Red, Tianaa White, and Tianaa Green. Tianeptine has caused serious adverse events, according to that agency. Tianeptine is illegally used to treat opioid use disorder, and pain and anxiety. It is not a vitamin, mineral, herb, among acid dietary substance; or a concentrate, metabolite, constituent, extract, or combination of those substances. Dr. Scott Gottlieb, FDA Commissioner, said in a statement, "The bottom line is this: we’ve seen growing instances where profiteers are pushing potentially dangerous compounds – often with unproven drug claims and … [Read more...]
Consent Decree Issued Against MyNicNaxs, Maker of Dietary Supplements
A federal court ordered a Florida-based company called MyNicNaxs to stop selling drugs and dietary supplements until it complies with the Federal Food, Drug, and Cosmetic Act and other requirements. The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction against MyNicNaxs of Deltona Florida. The company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers online through their websites. Some of these products tested positive for undeclared active pharmaceutical ingredients. Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a statement, "Marketing products with undeclared active pharmaceutical … [Read more...]
Consumer Reports Identifies 15 Dietary Supplements to Avoid
Consumer Reports has listed fifteen dietary supplement ingredients that consumers should avoid. These ingredients can cause organ damage, cardiac arrest, and cancer. Whether or not a person can develop these conditions depends on their own health, the quantity ingested, and the amount of time they are exposed to the ingredient. These ingredients can also interact with prescription medications such as statins and blood thinning drugs. They can even interact with common over the counter medications such as aspirin. Consumer Reports' investigators found all fifteen of these ingredients in products available online or in stores such as Costco, BNC, Target, Vitamin Shoppe, Vitamin World, Walgreens, CVS, Walmart, and Whole Foods. In 2013, a report from the Government Accountability … [Read more...]
Liver Damage Caused by Dietary Supplements Increases
Consumer Reports says a new study finds that some dietary supplements are causing liver damage. The study looked at cases of liver damage reported to the Drug Induced Liver Injury Network Program at the National Institutes of Health. About 700 cases of liver damage were reported during the study's time frame. And 130 of those cases were linked to dietary supplements. The study, published in the journal Heptology by Dr. Victor Navarro from the Einstein Medical Center in Philadelphia, states that the greatest risk of liver damage seems to be with bodybuilding and weight loss supplements. Those products caused about half of the cases of liver damage that were linked to supplements. But other supplements that are sold for depression, sexual performance, and digestive issues can be … [Read more...]
Beware of Illegally Marketed Diabetes Treatments
The FDA is advising consumers with diabetes to avoid illegally marketed treatments. They say that if it sounds to good to be true, it probably is. The phrases on products and dietary supplements to watch out for include "lowers your blood sugar naturally," "inexpensive therapy to fight and eliminate type II diabetes," "protects your eyes, kidneys, and blood vessels from damage," "replaces your diabetes medicine," "effective treatment to relieve all symptoms of diabetes," and "natural diabetes cure." If a product has these claims on the label, it's probably a scam. In addition to not meeting label claims, these products can contain harmful ingredients. They may be marketed as over the counter products when they require a prescription. And if people with diabetes rely on these … [Read more...]
FDA Issues Revised Draft Guidance to Improve Supplement Safety Notifications
The FDA issued a revised draft guidance on August 11, 2016 to improve dietary supplement companies' new dietary ingredient (NDI) premarket safety notifications to the government. These notifications help the FDA identify safety concerns before consumers buy these products. The Dietary Supplement Health and Education Act (DSHEA) requires a manufacturer or distributor to notify the FDA at least 75 days before marketing a supplement that contains a new dietary ingredient, unless the NDI is used in the food supply without chemical alteration. A new dietary ingredient is one that was not marketed in the U.S. before October 15, 1994. Supplements are considered adulterated if they contain an NDI not used in the food supply and if notification has not been submitted to the FDA 75 days … [Read more...]
FDA Says Some Imported Dietary Supplements Can Hurt You
The FDA says that if you buy imported products that are marked as "dietary supplements" and nonprescription drug products from flea markets, swap meets, online, or from ethnic or international stores, you could be harming your health. Health scammers often target people who like shopping at nontraditional outlets, especially those who have limited English proficiency. Cariny Nunez, M.P.H., a public health advisory in the Office of Minority Health at the FDA says, "these scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets." Some groups, such as Native Americans, Latinos, and Asians have a long tradition of using herbal or "natural" remedies. But "natural" does not mean "safe". Many "natural" products, such … [Read more...]
U.S. Marshals Seize Dietary Supplements Made with Kratom
The FDA has announced that U.S. Marshals, at the agency's request, seized almost 90,000 bottles of dietary supplements that contain kratom, a botanical substance that poses a risk to public health. This plant, whose Latin name is Mitragyna speciosa, grows in Thailand, Malaysia, Indonesia, and Papua New Guinea. It is toxic to multiple organ systems. Consumption of kratom can lead to respiratory depression, vomiting, nervousness, weight loss, and constipation. It has narcotic and stimulant effects and causes withdrawal symptoms, including hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements. The FDA issued an import alert last year to let U.S. officials detain imported dietary supplements and ingredients that contain kratom without physical … [Read more...]
