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.”
Study finds patients that have dry mouth use multiple medications
BALTIMORE Approximately 91% of dentists report that patients who are complaining about dry mouth are taking multiple medications, according to a nationwide member survey conducted by the Academy of General Dentistry released Thursday.
“The number of [dry mouth] xerostomia cases has increased greatly over time because people are taking more and more medications,” stated Cindy Kleiman, who presented the study. “General dentists are seeing this trend in their offices, which is why they are trying to learn all they can about this condition. The more they know, the better they will be at diagnosing and treating patients.”
Dry mouth, or xerostomia, is caused by a decrease in salivary function. It affects approximately one in four Americans, placing more than 25% of people at risk for tooth decay. There are more than 400 prescription and non-prescription drugs associated with xerostomia, according to Raymond Martin, a dentist. “Anti-depressants, painkillers, diuretics, antihistamines, tranquilizers and anti-hypersensitives can all contribute to dry mouth,” he said. “People who take several of these medications are more susceptible.”
As indicated by the AGD survey, the most common symptoms reported by patients include constant thirst and difficulty eating, swallowing or speaking. Foamy or stringy saliva, irritation of the tongue, burning of the tissues inside the mouth, painful ulcerations and dentin hypersensitivity (extreme sensitivity in one or more teeth) are also dry mouth symptoms. Over time, xerostomia sufferers may experience extensive tooth decay, tooth loss or gingivitis due to the lack of saliva.
Out of the nearly 500 general dentists who responded, 89% believe prescription medications are the primary contributor to dry mouth. Aging, dehydration and salivary gland disease were also cited as major contributors. Approximately 68% of the dentists said constant thirst is the most common symptom communicated by patients; 44% said patients have difficulty eating, swallowing or speaking. More than 92% reported that patients attempt to increase salivary production by drinking water; less than 58% reported patients tried taking over-the-counter saliva substitutes, chewing sugar free gum or sucking on hard candy.
ERSP determines Swiss Labs reliable support for dietary supplement claims
NEW YORK The Electronic Retailing Self-Regulation Program on Thursday determined that Swiss Labs provided reliable support for certain claims around the company’s Arthri-Zen Relief dietary supplement, but recommended the marketer modify certain claims.
ERSP examined claims in broadcast and online advertising that included:
- “Imagine 24-HOUR JOINT RELIEF!”;
- “Arthri-Zen eases: joint discomfort; muscle and tissue aches; sleepless nights; stiffness and swelling”;
- “Arthri-Zen Relief is clinically proven effective in the relief of joint and muscle discomfort.”;
- “…And natural products like Glucosamine and Chondroitin just don’t work.”; and
- “With its unique delivery system Arthri-Zen Relief works quickly and effectively. You’ll feel a difference immediately.”
Following its review, ERSP determined that the marketer’s clinical study provided adequate support for the marketer’s claims that the product could reduce joint and muscle discomfort when used as directed. However, given that a single study was performed, ERSP recommended that the marketer discontinue any reference to “clinical studies.”
ERSP noted in its decision that the marketer’s study indicated that 53% of the trial subjects who received the Arthri-Zen formulation experienced significantly less pain by the fourth day of the trial. ERSP noted that relief following four days of treatment is not consistent with consumers’ expectations of a product that advertises “immediate” relief. The marketer asserted that it would modify the claim, “immediate relief.”
ERSP further noted that that the marketer’s “24-HOUR JOINT RELIEF” claim could be interpreted by consumers as a reference to a systematic release of the product’s primary ingredients throughout the day. ERSP recommended that the marketer modify the context of the claim to clarify for consumers its intended message that users of the product can experience relief for up to 24 hours in between dosages.
Further, ERSP determined that, based upon the evidence presented by Swiss Labs it is inaccurate to categorically conclude that glucosamine and chondroitin provide no therapeutic benefits and noted that the advertiser has asserted it will voluntarily discontinue comparative claims involving glucosamine and chondroitin. ERSP recommended the marketer not disseminate the same or similar claims in future advertising for Arthri-Zen Relief.
“While we believe that all of our advertising is fully substantiated, we have decided to accept ERSP’s recommendations in its entirety and will make the minor recommended modifications to our advertising,” Swiss Labs stated. “Swiss Labs appreciates the insight and expertise provided by this process and will take this guidance into consideration in future advertising.”