CRN: No safety issues with fish oil
WASHINGTON In response to a lawsuit filed Tuesday in California, which claimed that fish oil supplements allegedly are contaminated with polychlorinated biphenyl, an organization representing the manufacturers and ingredient suppliers of such products said the claims are false.
The Council of Responsible Nutrition issued a statement late Tuesday refuting claims submitted in a lawsuit that names eight makers and sellers of fish oil, shark oil, fish liver oil and shark liver oil supplements that have PCB contamination above the safe harbor limits set for human PCB consumption under California’s Proposition 65 — a law requires consumers to be warned about such exposures. Andrew Shao, CRN SVP scientific and regulatory affairs, pointed out that the Food and Drug Administration has established a PCB tolerance level and that the lawyers in this case are “attempting to frame this as a public health concern, when in reality, fish oil has enjoyed decades of safe use.”
“PCBs are ubiquitous within the environment, which means that all fish — whether fish found in oceans and rivers or fish oil supplements — contain at least trace amounts of PCBs,” Shao said. “The FDA has established a tolerance level for PCBs in fish, which is 2.0 parts per million (ppm, also expressed as mg/kg) or 2,000 parts per billion; in comparison, the Prop 65 daily limit for PCBs for a cancer warning is 90 ng/day, which is significantly lower than what FDA deems safe.”
In line with this response, Pharmavite, maker of Nature Made products and one of the manufacturers listed in the lawsuit, said it believes the group performed a single test on one omega-3 fatty acid sample to develop their conclusions.
“Pharmavite believes that the findings presented by the fishoilsafety.com consumer group today are anomalous or in error,” the company said in a release. “The magnitude of the science supporting the benefits of consumption of fish oil far outweighs the results of this extremely limited investigation.”
Hi-Tech acquires Mag-Ox line from Blaine
AMITYVILLE, N.Y. Hi-Tech Pharmacal on Tuesday announced the signing of an acquisition agreement for the Mag-Ox line of Magnesium Nutritional supplements from Blaine Co. in a transaction valued at $4.1 million.
Under the terms of the acquisition Hi-Tech receives rights to the Mag-Ox, Maginex, Uro-Mag and Corban brands. The products had net sales of approximately $3.4 million in calendar 2009.
“The acquisition of these magnesium brands is a good strategic fit for [Hi-Tech’s] diabetic line since magnesium is a common nutritional deficiency among people with diabetes as well as those with metabolic syndrome, high blood pressure and cardiovascular conditions,” stated David Seltzer, Hi-Tech president and CEO.
Evander Holyfield delivers one-two punch with Gamma
LAS VEGAS Gamma Pharmaceuticals on Monday announced a joint venture with Evander Holyfield, former world heavyweight boxing champion.
The joint venture, branded “Holyfield Choice,” will be formulating and marketing a line of vitamins and nutritional products. The brand currently has four product lines and seven SKUs in production.
“We believe the potential of the Holyfield’s Choice brand is global and virtually limitless,” stated Peter Cunningham, Gamma CEO. “We have been in advance marketing discussions with the wholesale distribution channel and leading retailers, and the response has been remarkable,” he said.
In addition, Evander will soon be launching the ‘Holyfield Challenge,’ a national fitness and health program aimed at school-age and college-age students that will be rolled out to secondary schools and colleges around the country. Holyfield Choice fitness, nutrition and supplement products will be a key element of the youth-oriented program.