CRN: Dietary supplement manufacturers must be GMP-compliant
WASHINGTON The Council for Responsible Nutrition on Friday noted that all dietary supplement manufacturers without exception now are legally bound to comply with dietary supplement-specific good manufacturing practices.
With the third and final phase-in of the law, small dietary supplement firms (those with less than 20 employees) now join large and mid-sized companies in the legal requirement to be GMP-compliant.
“This is a historic day for the dietary supplement industry and its consumers,” stated Steve Mister, CRN’s president and CEO. “Full implementation of the GMP regulations that we fought so hard for should put to rest any skepticism that our industry is not regulated. Clearly, there are stringent manufacturing standards that our entire industry must adhere to, and we expect that after three years of preparation for implementation, manufacturers are prepared to embrace GMP compliance as another illustration of an industry committed to its consumers.”
The CRN also encouraged the Food and Drug Administration to ensure that the industry is meeting GMPs by conducting inspections.
“[The] industry worked hard to get GMPs and we now expect the FDA to make complete use of the standards by holding the industry to them,” Mister said. “Full implementation of the GMPs, coupled with FDA attention to industry compliance, will help to weed out bad actors from our legitimate industry and assure that consumers are being protected.”
GSK licenses OTC Xerclear; U.S. market excluded
LONDON GlaxoSmithKline on Wednesday announced an exclusive agreement for the over-the-counter rights to Medivir’s cold sore treatment Xerclear (acyclovir and hydrocortisone) in key global markets. The trade name in the U.S. market is Lipsovir, which was approved as a prescription remedy for the prevention of cold sores in July 2009.
Under the terms of the agreement, GSK gains exclusive rights to market and distribute non-prescription Xerclear as part of the Zovirax franchise, across multiple markets, including Europe, Russia, Japan, India, Australia and New Zealand. The agreement excludes North and South America, China, South Korea and Israel.
“This alliance demonstrates GSK’s ongoing commitment to invest in and expand our OTC business. It will help strengthen our dermatology portfolio across multiple territories including several key emerging markets,” stated John Clarke, president, GSK Consumer Healthcare.
GSK will assume responsibility for funding ongoing and future development of Xerclear in all territories covered by the agreement.
Xerclear is the first and only topical herpes labialis (cold sores) treatment clinically proven to help prevent cold sore lesions appearing, GSK stated.
Gaia Herbs debuts new look and Meet Your Herbs program
BREVARD, N.C. Gaia Herbs on Tuesday announced the launch of its new branding, new packaging and a new industry-first herb traceability program called Meet Your Herbs.
Meet Your Herbs will provide lot-by-lot, consumer-accessible traceability of the regional origin, harvest story and quality test results of the company’s herbal ingredients and finished products. Consumers and retailers will be able to retrieve information about the company’s products by entering an ID number from the package into the “Meet Your Herbs” field on the company’s website or through a new mobile device application. A demo of the traceability feature is available at Gaia Herb’s new website, New.GaiaHerbs.com.
“We believe that every herb needs to be held to the highest standards of purity and integrity in order to ensure maximum potency and results for our consumers,” stated Ric Scalzo, CEO of Gaia Herbs. “We also feel that it is not enough to simply state these claims, so we are offering accountability through complete transparency with our Meet Your Herbs traceability program.”