Minnesota company barred from going to market for violations of drug and dietary supplement regs
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.
Hebron USA launches Brazilian probiotic into U.S. market
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.
Kentucky initiates awareness campaign around ‘smurfing’ of PSE products
LEXINGTON, Ky. — Gov. Steve Beshear on Monday announced the launch of a privately funded, statewide campaign aimed at increasing public awareness about "smurfing," the illegal process of buying products containing pseudoephedrine on behalf of methamphetamine criminals. The goal of the Anti-Smurfing Campaign is to inform potential smurfers and the general public — through signage displayed at pharmacy sales counters — that smurfing is a serious criminal offense that can result in criminal charges and possibly time in jail.
The initiative was developed by the Consumer Healthcare Products Association and will be carried out by Kentucky retailers on a voluntary basis.
“Meth has an enormous fiscal and criminal impact on Kentucky, and I am committed to working with leaders across the state to combat the use of this deadly drug," Beshear said. "Smurfing is a main component of the criminal meth process and I want to thank the industry leaders and retailers who are sponsoring this anti-smurfing educational effort.”
“The Anti-Smurfing Campaign also has broad support from the Kentucky retail and law enforcement officials," noted Scott Melville, CHPA president and CEO. "In addition to exploring policy solutions to methamphetamine production and abuse, Kentucky leaders recognize the clear need for a public awareness campaign to inform responsible consumers and meth offenders of the criminal and moral consequences of buying pseudoephedrine for meth cooks.”
The Kentucky Pharmacists Association and the Kentucky Retail Federation, both co-sponsors of the campaign, have already begun distributing Anti-Smurfing signage to retailers across the state. The campaign is part of Gov. Beshear’s commitment to fighting drug abuse through public awareness and legislative solutions.
Gov. Beshear joined members of the General Assembly, representatives from the Kentucky Retail Federation, the Kentucky Pharmacists Association and the CHPA for the anti-smurfing announcement.