January 22, 2022

FDA Allows Qualified Health Claim For Magnesium and Blood Pressure

The FDA is allowing a qualified health claim for magnesium and blood pressure, that it will not object to the use of certain health claims regarding the consumption of that mineral and a reduced risk of high blood pressure. The claim will be allowed if it is "appropriately worded" to avoid misleading consumers, and if other factors for the use of this claim are met. A petition was submitted on behalf of The Center for Magnesium Education and Research, LLC. It requested that the FDA authorize a health claim about the relationship between the consumption of magnesium and the reduced risk of high blood pressure. A health claim iterates the relationship between a substance and a disease or health-related condition. The petition was reviewed, along with other evidence related to the … [Read more...]

FDA Warns Against Black Oxygen Organics Fulvic Care Powder and Tablets

The FDA is warning consumers not to take Black Oxygen Organics Fulvic Care Powder and Tablets dietary supplements because they may contain elevated levels of lead and arsenic. Immediately stop using the product and do not let other household members or pets to use them. These products were sold online at the company's website. Black Oxygen Organics Fulvic Care Powder and Tablets were sampled at the U.S.-Canadian border, where the high levels of the heavy metals were found. The FDA detained the shipment and put the product under Import Alert 99-42. You can see pictures of product labels at the FDA web site. More shipments of the product were detained after September 14, 2021, but the firm released those products into commerce without the FDA's knowledge when they should have been … [Read more...]

Blackstone Labs Conspired to Sell Unlawful Dietary Supplements

Blackstone Labs and two of its executives pleaded guilty to conspiring to sell illegal anabolic steroid and unlawful dietary supplements, according to the U.S. Justice Department. According to court documents, on November 17, 2021, the executives, Phillip Braun and Aaron Singerman, pleaded guilty to distributing controlled substances and to selling unapproved new drugs.in violation of FDA statutes through their company, which was located in Boca Raton, Florida. The defendants admitted that, from 2012 through 2017, they conspired to sell products that were unapproved new drugs and/or illegal controlled substances, while they falsely characterized their products as safe and legal dietary supplements under the Designer Anabolic Steroid Control Act. The products were also falsely … [Read more...]

U.S. Grandma’s Herbs Consent Decree of Permanent Injunction

A consent decree of permanent injunction has been entered between U.S. Grandma's Herbs, Inc. of St. George, Utah, and the company's owners. The company allegedly marketed products as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs, according to an FDA news release. The U.S. District Court for the District of Utah entered the consent decree on behalf of the FDA. The FDA has not approved Grandma's Herbs products for any use. The company has claimed that the products could be used to "diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy." Judy McMeekin, Pharm.D., FDA’s associate commissioner for regulatory affairs said in a statement, "The … [Read more...]

Supplement Company Owner Pleads Guilty to Selling Steroid-Like Drugs

A New Jersey supplement company owner pleads guilty to introducing an unapproved new drug into interstate commerce "with the intent to defraud and mislead the U.S. Food and Drug Administration (FDA) and consumers," according to a news release from the U.S. Department of Justice.  The owner is Nicholas Andrew Puccio. The government alleges that from 2016 to 2020, Puccio marketed drugs as dietary supplements to the bodybuilding and fitness community. The supplements allegedly included a product labeled as containing ostarine, a type of synthetic steroid known as a Selective Androgen Receptor Modulator (SARM). Dietary supplements cannot contain unapproved drugs or they are considered unapproved new drugs by the FDA. The FDA has long warned against the use of SARMs, stating that they … [Read more...]

FDA Warns Companies For Selling Dietary Supplements With False Claims

The FDA has warned 10 companies for selling dietary supplements with false claims, sending them warning letters. These supplements "claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act)." The warning letters were issued to: Enlifta LLC; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc. Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA's Center for Food Safety and Applied Nutrition, said in a statement, "Dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health … [Read more...]

FDA Says Some Weight Loss, Other Supplements May Be Dangerous

The FDA has released a consumer update stating that weight loss products and other supplements, including male enhancement products, that are sold online or in stores may be dangerous because they may be illegal. Some of these dietary supplements can be made with potentially dangerous ingredients that are not listed on the label. Over the past 10 years, the FDA has waned consumers that some products that are sold over the counter contain active hidden ingredients. This is especially the case for products that are marketed for weight loss, pain relief, body building, sleep aids, and male enhancement. Some of these products are actually drugs and are falsely represented as being dietary supplements. FDA has also found products that are marketed as supplements that claim to treat or … [Read more...]

FDA Finds Bitter Orange Supplements Can Contain Unapproved Drugs

The FDA has released a study that finds some bitter orange dietary supplements can contain unapproved drugs. This supplement is sold as a sports performance supplement and weight management supplement. It became popular after Ephedra products, a type of amphetamine, were banned from the U.S. after it was linked to heart attacks, strokes, seizures, and sudden deaths. But as Consumer Reports points out, the government agency hasn't begun enforcement action against the companies that make these products, nor has it warned consumers about them. Manufacturers claim that bitter orange supplements increase energy and suppress appetite. The bitter orange supplements can contain synephrine, an amine, which can cause adverse cardiovascular events, especially when taken with caffeine. For … [Read more...]

CSPI Urges FDA Action Against Supplement COVID-19 False Claims

The Center for Science in the Public Interest (CSPI) is asking the FDA and the Federal Trade Commission (FTC) to take enforcement action against supplement COVID-19 false claims. The watchdog group found 46 products on Amazon that claimed their supplements fight viruses in a scan on May 29, 2020. CSPI also wants Amazon to delist these products and to work with the FDA and FTC to protect consumers from these manufacturers' false claims. And CSPI adds that those 46 listings are just a small sample of the "illegal and potentially unsafe supplements currently sold on Amazon and other online retailers." Federal law prohibits dietary supplement makers to claim that they prevent, treat, or diagnose any disease, including coronavirus. Many of the supplements CSPI found for sale implied … [Read more...]

Life Rising Dietary Supplements Seized by U.S. Marshals

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...]

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