Dept. of Justice files complaint for permanent injunction against dietary supplement manufacturers
ROCKVILLE, Md. The Department of Justice, on behalf of the Food and Drug Administration, on Friday announced the filing of a complaint for permanent injunction against Quality Formulation Laboratories, American Sports Nutrition, Sports Nutrition International and Mohamed Desoky, who oversees operations at all three companies.
The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.
The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice by manufacturing and storing food under “filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.”
The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.
During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.
FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.
In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections but failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.
“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” stated Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”
Supervalu announces retirement of two executives, change in leadership structure
NEW YORK The pending retirement of Kevin Tripp as EVP and president of Supervalu’s Retail Midwest region marks a big changing of the guard for one of chain pharmacy’s biggest players. Still unclear is if whether it also signals an exit from the retail pharmacy industry of this well-known and respected executive.
Tripp, a veteran pharmacy leader with more than three decades in pharmacy and operations management at Albertsons and American Stores, has had a major impact on Supervalu’s sprawling pharmacy business, driving the company to adopt and expand new patient-care models and forge closer ties with health plan payers, health advocacy groups and patients themselves.
Tripp came to Supervalu through its purchase of much of the Albertsons retail empire in 2007, and has been the ultimate decision-maker for Supervalu’s pharmacy operations. Among his reports is Chris Dimos, president of the pharmacy division; together, the two leaders have significantly broadened the clinical and patient-education services offered by Supervalu pharmacists, and championed new reimbursement models for those services from the health plan sponsors footing the bills for patients.
At Albertson’s, Tripp actively promoted certification for diabetic management among the chain’s more than 5,600 pharmacists and more than 2,000 certified pharmacy technicians, overseeing a program that qualified many pharmacists as certified diabetic educators and one of retail pharmacy’s most extensive disease management and diabetic care service offerings.
That commitment continued at Supervalu. Under Tripp’s direction, Supervalu expanded deeply into clinical care services and added new incentives to lure customers to the company’s more than 920 supermarket-based and stand-alone pharmacies. On a periodic basis, those pharmacies offer health screenings for diabetes, heart health, thyroid conditions and other diseases, and education by pharmacists in its stores to help patients prevent or live with a variety of conditions from diabetes to headaches.
In a bid to increase compensation by health plan payers for pharmacist-delivered patient-care services, Tripp and Dimos also oversaw the launch of Vitality Check, a health assessment program for health plan members and other patients delivered by company pharmacists for a fee.
Supervalu’s clinical care and patient education efforts have gained the company plaudits from health advocates. One example: an Award of Meritorious Achievement, presented in April from the American Heart Association for raising awareness of heart disease and its causes.
Under Tripp and Dimos Supervalu’s pharmacy team also wrestled constantly with new ways to merge the in-store pharmacies in its sprawling network of supermarket holdings — which include Jewel-Osco, Albertsons, Supervalu, Cub Foods, Lucky, Acme, Shaw’s and Shop ‘n Save, among other chains across the United States — with the offerings in its food aisles. A prime example: the company’s Eating Healthy with Diabetes program, under which the pharmacy, patient education and healthcare services offered by the pharmacies are tied to a broader, holistic approach to wellness and disease prevention.
“The way we go to market is, we want our customers — regardless of which of our banners they’re having their prescriptions filled in — to have a common experience. And how we engage them with some of our newer programs or clinical programs may shift depending on the banner,” Tripp explained in one interview with Drug Store News. “All these banners entered the organization at different points,” he added. “Some of them, like Cub, Jewel-Osco and Sav-on, are already well developed along the clinical pathway. Some of the other banners weren’t quite there yet, but they’re quickly catching up.”
Long term, said Tripp, “The vision is that we’ll have a national enterprise, and based on our ability to execute [various clinical programs] within the states, we will.”
Supervalu’s quest to integrate its pharmacies with other store capabilities will continue following Tripp’s retirement. That much was clear from the company’s announcement that it will restructure to create a new health-and-wellness division under Duncan Mac Naughton, EVP merchandising and marketing. The goal, according to Supervalu’s announcement, is to do a better job of welding together the pharmacy and health and beauty offerings, “creating a total health-and-wellness experience for customers.”
Fairhaven Health partners with fertility expert for product line
BELLINGHAM, Wash. Fairhaven Health on Friday partnered with fertility expert and OB-GYN Amos Grunebaum around a product line — FertilAid — that helps couples conceive naturally. And once pregnant, Fairhaven Health offers products that provide the nutritional support women need to help ensure a healthy pregnancy and beyond.
FertilAid for Women is a fertility-enhancing supplement designed for trying-to-conceive women. The formula combines vitamins, minerals and antioxidants with an herbal fertility enhancing blend designed to restore female hormone balance, promote regular ovulation and support overall reproductive wellness.
FertilAid for Men is a formula designed to improve male fertility. Clinically shown in a recent study to improve the total number of motile sperm, FertilAid for Men provides a comprehensive formula to improve sperm parameters such as count, motility and morphology, Fairhaven stated. Suggested retail price for both products is $28.95.
“Our FertilAid supplements are very popular with couples who are just beginning their conception efforts,” Grunebaum stated. “These couples are simply looking to accelerate the time in which they are able to achieve pregnancy, and to do so in as healthy a manner as possible.”
According to Fairhaven, there are a number of factors that contribute to a difficulty to conceive. For example, as women have entered the working world in increasing numbers, the average age at which they begin trying to conceive is older. According to the American Fertility Association, the probability of having a baby decreases between 3% and 5% per year after the age of 30.
There’s also nutrition and lifestyle, Fairhaven noted, such as being overweight or obese. In addition, drinking alcohol, caffeine intake and smoking can negatively impact conception odds.