HEALTH

Black Friday shoppers in Manhattan who overindulged the day before offered relief with Di-Gel

BY Michael Johnsen

NEW YORK — Ilex Consumer Products Group successfully addressed the post-Thanksgiving gastrointestinal distress for New Yorkers who ventured out to Fifth Avenue on Black Friday with more than 2,000 samples of the company’s recently launched Di-Gel for stomach discomfort. 

Di-Gel hosted a “Comfort Zone” along Fifth Avenue in Manhattan with free, clean restrooms for shoppers. “Given the recent events in New York City, we thought this was the right time to host this event, support local businesses and make Black Friday shoppers a little more comfortable,” stated Bernie Kropfelder, EVP and general manager of OTC at Ilex Products Group.

The Di-Gel campaign, which launched with the brand tagline, “When you overdo, undo”, highlights the various triggers that lead soon-to-be users to overdo it at times, such as overeating and stress, among other things. “We all overdo it at times, and we often pay for it with an upset stomach. Di-Gel is the solution for when that catches up with you,” Kropfelder said. 

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Minnesota company barred from going to market for violations of drug and dietary supplement regs

BY Michael Johnsen

SILVER SPRING, Md. — Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements. 

The consent decree of permanent injunction that had been sought by the Food and Drug Administration was signed by U.S. District Judge David Doty of the U.S. District Court for the District of Minnesota on Nov. 6. 

A consent decree for permanent injunction restrains a company from distributing any products into interstate commerce, until they comply with FDA regulations and allows the FDA to assess damages against the company for any future violations of the law or the consent decree.

PUH is to stop distributing its products until all disease claims are removed from its web sites, product labels, and all other products and web sites under PUH’s or Poindexter’s custody or control. 

PUH and Poindexter also must comply with cGMP requirements for dietary supplements.

“The FDA works with companies to ensure that their processes comply with the public health requirements in our laws and regulations,” stated Melinda Plaisier, the FDA’s acting associate commissioner for regulatory affairs. “But when a firm refuses to comply, we will take aggressive enforcement action.”

The company marketed products online at www.puhcorp.com and www.doc-nt.com claiming that the "dietary supplement products" treated serious medical conditions such as prostate cancer, high cholesterol, hypertension and congestive heart failure. Under federal law, products offered for such use are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. The company’s products are drugs that have not been approved by the FDA for their claimed uses, the agency stated. 

During a 2012 inspection of PUH, the FDA also found that the company distributed dietary supplements that were not manufactured in accordance with the current good manufacturing practice requirements for dietary supplements.    

The products, marketed under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, included capsules, topical creams and botanical extracts under the brand names Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract and Progesterone Cream, among others.

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Hebron USA launches Brazilian probiotic into U.S. market

BY Michael Johnsen

NEWBURY, Ohio — Hebron USA on Monday announced the launch of the Florax DS, a line of ready-to-drink probiotics that doesn’t require refrigeration. 

Florax DS products are formulated with a proprietary strain of the probiotic yeast called Saccharomyces Cerevisiae Cepa Fr 1972, also known as a nutritional or brewers’ yeast.  

The Florax DS RTDs will be available in two flavors — original and raspberry — through Drugstore.com, Meijer, Discount Drug Mart and Rainforestsremedies.com.

Hebron USA earlier this year introduced brands popular in Brazil into the U.S. market at the ECRM Cough & Cold and Allergy EPPS.

That launch included two products familiar with South Americans — Bromelin DS and Propolis DS. Bromelin is a dietary supplement that supports healthy respiratory function with a natural extract made from pineapples. Propolis, also a dietary supplement, helps coat and soothe the throat with its Propolis Extract, a natural ingredient harvested by honeybees.

Hebron USA then shared with ECRM Cough & Cold and Allergy attendees a sneak peak of Florax DS, which boasts a 36-month shelf life and features a QR code on the back of the packaging that directs consumers to the company’s web site, Hebronus.com.

 

 

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