Products can’t claim effectiveness against diseases, FDA says
ROCKVILLE, Md. The Food and Drug Administration on Friday announced that Brownwood Acres Foods, Cherry Capital Services—doing business as Flavonoid Sciences—and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.
The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as “Chemicals found in Cherries may help fight diabetes.” The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products’ label and labeling comply with the law, the FDA stated.
“The FDA will not tolerate unsubstantiated health claims that may mislead consumers,” stated Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers.”
Brownwood Acres Foods and Cherry Capital Services manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine and salmon oil capsules.
The decree was signed by Judge Paul Maloney on Feb. 19 in the U.S. District Court for the Western District of Michigan.
Matrixx launches Xcid exclusively at Wal-Mart
PHOENIX Matrixx entered the digestives space exclusively with Wal-Mart last week with its launch of Xcid, Carl Johnson, president and chief executive officer, told analysts attending the Roth Capital Partners 20th Annual OC Growth Stock Conference on Wednesday.
The product contains two active ingredients—calcium carbonate and magnesium hydroxide—and is formulated as a rich and creamy formula that’s similar to a dessert-like mousse, Johnson said. “Consumer research has [found] there’s a five-to-one preference for our product versus existing tablets like Tums or existing liquids like Maloxx.”
Wal-Mart will have the brand exclusively for the first several months as Matrixx better gauges the potential for the product, Johnson said. “We probably are thinking today it’s somewhere between a $5 million and $10 million opportunity for the company, but we’ll know better after we have a few months of sales data with Wal-Mart. But obviously when you get the No. 1 retailer in the United States excited about it, that gets us excited and optimistic that this will be a good addition to the company.”
Reckitt Benckiser debuts two products in European markets
SLOUGH, England As a possible taste as to what innovation Reckitt Benckiser will bring to the U.S. market with its Boots Healthcare brands, Reckitt last week announced the launch of two healthcare products to be introduced into its European markets.
The first is a convenience version of its liquid heartburn reliever Gaviscon—Gaviscon Liquid Sachets. “Consumers genuinely think that the liquid is better than the tabs … but normally when you’re on the go they typically use tablets,” commented Bart Becht, Reckitt Benckiser chief executive officer, in a conference call with analysts last week. “They would like to use the liquid but they can’t because that is not an on-the-go format. … So what we’re providing is liquid sachets,” he said, where a consumer can tear off the top of the pouch and drink one dose. “That’s going to market as we speak.”
The second product launch is a fast-acting ibuprofen pain reliever Nurofen Express. “Nurofen Express is already launched in the U.K. and is now going to get gradually rolled-out to markets,” Becht said. “Clearly there’s a regulatory process so this will take several years just to be clear before it will be fully rolled-out … [but] this product provides the pain relief twice as fast as standard ibuprofen products.”
Reckitt Benckiser executives have not yet confirmed that they will launch their entire platform of Boots Healthcare products into the U.S. market—it’s too soon following the acquisition of Adams Respiratory, they’ve said—but the fact that Adams affords Reckitt Benckiser an established entry into the U.S. healthcare market was one of the selling points in acquiring Adams, Becht explained. “What’s the benefit [of the Adams acquisition]? It clearly provides a healthcare infrastructure in the U.S. which is the largest consumer healthcare market in the world. … It was very strategic for us as a company because it’s one of the few targets that allows us to get a healthcare infrastructure in the U.S., which we don’t have. And to build that organically is extremely difficult and costly.”