FDA cracks down on violators of dietary supplement regulations
SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.
A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.
Berst marketed the products on his website as alternative herbal medicine for such serious disease conditions as cataracts, viral and bacterial infections, and cancer. Under the Federal Food, Drug and Cosmetic Act, a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. Berst’s products are drugs that have not been approved by FDA for their claimed uses, the FDA noted.
“This company has ignored previous FDA warnings, and has continued to produce and distribute products in violation of federal law,” stated Melinda Plaisier, FDA’s acting associate commissioner for regulatory affairs. “The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements.”
The FDA sought the injunction after Berst failed to comply with previous warnings, continuing to market products in violation of federal law. Berst is appealing the injunction with the 9th Circuit Court of Appeals, the FDA reported.
And FDA secured a cease-and-desist agreement from Venus Pharmaceuticals International of Hauppauge, N.Y. Venus CEO Bharat Kakumanu has agreed to stop production and distribution of dietary supplements into U.S. commerce, and to recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice regulations. In addition, the firm is prohibited from exporting products unless such activity is in compliance with FDA laws and regulations.
“When a company violates public health protections, they put consumers at risk,” Plaisier said. “Our goal at the FDA is to ensure that consumers have access to dietary supplements that meet good manufacturing practices, so that the products do not harm consumers.”
As part of the consent decree, the company must implement a series of corrective actions before it can resume production of dietary supplements. The actions include changing procedures for manufacturing, packaging and labeling dietary supplements so that they meet FDA requirements. In addition, the company must hire an outside auditor to oversee and review progress in implementing the needed changes.
Nothing good can happen if a company ignores the warnings from FDA and continue to produce and distribute medicines that are a violation of federal law. My aunt found The proper diet after a friend suggested to try some herbs produced by an American Company, she lost 5 pounds and wants to lose more, her courage is immense.
The FDA doesn't mess around. However are the people buying the product really doing the research for the herbal dietary supplements or just blindly trying anything to slim their waste? For example, I have high cholesterol and before I just swallow anything that says that it will lower my cholesterol I do a little research about it such as go to www.herbalent.com/?p=114 and see that Guggul and fiber are the best methods if I want to go the natural route. Pretty simple people.
Novartis outsources production to bring back top-selling OTC brands to market
BASEL, Switzerland — Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic. First shipments to retailers were made in October.
The products will be available to consumers over the course of the fourth quarter, Novartis announced. And it is unlikely that any shipments will come out of the Lincoln plant anytime this year, as the restart of commercial production is taking longer than the company originally anticipated.
"We’ve announced the launch of Excedrin Migraine, Triaminic, Lamisil and Excedrin Extra Strength," Brian McNamara, division head Novartis OTC, told analysts Thursday. "We’re continuing to focus on bringing up our biggest brands at third parties, as we speak, to relaunch for next year. The margin impact is short-term."
"I’m still not happy with the progress that we’re making in Lincoln," Joseph Jimenez, Novartis CEO, told analysts. "So we are ensuring our return to market through third-party manufacturers, which will reduce our dependence on the remediation efforts at Lincoln. … We’re making progress, but it’s just not fast enough, and we’re returning to market with co-packers," he said. "We have very strong relaunch plans in place, and we’re executing now to regain our market share."
And Novartis won’t be getting out of the consumer health business anytime soon, Jimenez added, responding to an analyst question on what parameters would have to be met before Novartis considered exiting a particular division. "Consumer health plays a very important role. While it’s not a huge division, it’s still a division that pre-Lincoln generated over $3 billion in sales and will be a good grower," he said. "Strong brands, so strong consumer loyalty as evidenced by all of those consumers in the U.S. who are writing us and asking us to bring back Excedrin because nothing else works, in their mind. So these are very, very strong brands, and Consumer Health plays a very important role."
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GelStat updates SEC filings, positions for future growth
PALM CITY, Fla. — GelStat is primed to grow its OTC remedy business, according to a letter to shareholders and prospective investors released Tuesday.
The company recently updated historic annual and quarterly reports with the Securities and Exchange Commission, noted Gerald Kieft, Gelstat CEO. "GelStat is now positioned to file a form 10 and become a fully reporting company or file the required documents to become an alternative reporting company on the OTC Markets," he wrote. "Either decision will provide better transparency to the investment community."
Kieft shared with investors that GelStat plans to promote its GelStat Migraine and GelStat Sleep products in the direct-to-consumer channel. In addition, GelStat is on the lookout for acquisitions or the distribution rights to additional healthcare products.
"We have already made significant progress on a number of the aforementioned objectives and expect to be releasing additional information soon," Kieft concluded.
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