November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

November 19, 2013

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

The retail value of the seized products is more than $2 million, the agency estimated.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.

During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

November 11, 2013

The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets.

November 7, 2013

Aisle7 on Thursday announced the launch of Healthnotes Interactions Checker, a next-generation solution simplifying the task of deciding which nutrients positively or negatively interact with the medicines they take.

November 7, 2013

Alleradd on Wednesday launched its namesake product — a dietary supplement product to help students focus as a healthy, quick-acting alternative to energy products with no harmful side effects.

October 31, 2013

A new book from a trade group representing makers of dietary supplements details the laws and regulations that govern the industry.

October 30, 2013

Natural dietary supplement and OTC product maker Quantum Health has hired a new CEO, the company said.

October 25, 2013

Pure Encapsulations on Thursday introduced PureHeart Probiotic, the newest addition to the PureHeart Protocol: Screening + Supplements = Success line of nutritional supplements.

October 22, 2013

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

October 21, 2013

The National Advertising Division last week recommended that Maximum Human Performance, which markets the dietary supplement MYO-X Myostatin Inhibitor, discontinue the advertising claims and testimonials at issue in NAD’s review.

October 21, 2013

The Electronic Retailing Self-Regulation Program last week determined that Kowa Health Care America can support general performance claims for Okinawa Life, a dietary supplement marketed as providing a variety of health benefits.

October 18, 2013

The Council for Responsible Nutrition, the dietary supplement industry’s leading trade association, earlier this week announced the addition of three new voting members, including Barrington Nutritionals, Stratum Nutrition and Vitatech Nutritional Sciences.

October 15, 2013

Two associations representing the dietary supplement industry issued separate statements in response to what they characterized as a faulty meta-analysis, “Effects of Vitamin D Supplements on Bone Mineral Density: A Systematic Review and Meta-Analysis,” published last week in The Lancet.

October 14, 2013

USA Today on Monday morning reported two products marketed as dietary supplements in outlets including Walmart.com and GNC have actually been adulterated with a chemical similar to methamphetamine.

October 10, 2013

When multiple multinational companies start investing their acquisition monies into one particular category, it’s a good bet that category is poised for some pretty significant growth.

Right now, that category is dietary supplements

October 2, 2013

DSN visited the Baltimore Convention Center last week to check out the Natural Products Expo East. DSN reviews its top 10 new products from the show.

September 25, 2013

Looking into a company masquerading adulterated pharmaceuticals as miracle dietary supplements branded Reumofan, USA Today investigative journalists traveled as far as Mexico to find those responsible.

September 23, 2013

Use of specific dietary supplements in targeted populations not only provides health benefits, but also, according to a new economic report released Monday, offers significant savings for healthcare costs.

September 16, 2013

The Council for Responsible Nutrition last week published the third edition of its “Vitamin and Mineral Safety” handbook.

September 5, 2013

The Natural Products Association took exception to the October issue of Consumer Reports, charging the publication with making "verifiable misstatements" on the safety and regulatory requirements around dietary supplements in an article titled "4 ways to avoid supplement dangers."

August 23, 2013

The Electronic Retailing Self-Regulation Program recommended that Lonza America modify certain “clinically” proven claims for the company’s Alomune dietary supplement.

August 21, 2013

Nine top legal minds in the dietary supplement/functional food industry will participate in an innovative, cut-to-the-chase, panel-style presentation addressing nine topics to help companies protect themselves against the rising tide of class-action lawsuits during The Conference, the Council for Responsible Nutrition announced.

August 19, 2013

The Council for Responsible Nutrition last week announced that Ron Brownstein, whom the Washington Post called “one of the gold-plated names of political journalism,” has been added to the speaker line-up at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry, taking place in Park City, Utah, Sept. 18 to 21.

August 19, 2013

DrFuhrman.com informed the National Advertising Division that the company has discontinued certain advertising claims — including “anti-cancer” and cancer treatment claims — made for the company’s Immunotect dietary supplement.