Natural Products Insider – Regulatory Updates: FDA Issues Warning on Imported Vitamin – April 7, 2011

April 7, 2011 By

WASHINGTON—FDA issued a consumer warning regarding Soladek, a vitamin product marketed by Indo Pharma SA, based in the Dominican Republic, as the product may contain dangerously high levels of vitamins A and D. In its warning, FDA noted Soladek is marketed with Spanish language labeling featuring claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.”

TC Demands Company Stop Cancer Claims

WASHINGTON—The herbal products company Daniel Chapter One (DCO) and its principal, James Feijo, are facing civil penalties from U.S. Department of Justice that require them to stop making deceptive claims on the company’s daily radio show and website about the supposed cancer-fighting properties of its supplements. The civil penalty, which came per the Federal Trade Commission’s (FTC) request, said Feijo and the company violated an FTC Order and requires DCO and Feijo to send a notice to purchasers explaining the FTC’s findings that the advertisements were unsubstantiated, as required by the FTC Order

Conference Discusses China-U.S. Import Regs

COLUMBIA, Md.—The Food and Drug Law Institute LLC (FDLI), and will address various laws and policies that govern the food, cosmetic, drug and medical device industry in the United States and in China during conferences and training opportunities in Beijing and Shanghai from June 13 to June 16, 2011.

The key topics and discussions will include detailed analyses and explanations of the current legal, regulatory and economic environment for importing foods, cosmetics, dietary supplements, pharmaceuticals and medical devices into the United States from China. According to, the conference represents substantial business opportunities for Chinese manufacturers and will help explain significant changes in FDA policy and U.S. law affecting manufacturers of FDA-regulated products.

THE BEST Enhancer Recalled for Containing ED Drug

PARAMOUNT, Calif.—AVNS Inc. voluntarily recalled THE BEST Enhancer Supplement after being informed by its manufacturer, Drive Total Energy, that FDA lab analyses found the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male erectile dysfunction (ED). The active drug ingredient is not listed on the product label, and makes these products unapproved new drugs, as far as FDA is concerned.

Soluble Products Receives FDA Warning

LAKEWOOD, N.J.—Soluble Products Co. LP received a warning letter from FDA in late March related to violations of 21 CFR Part 111, related to cGMPs (current good manufacturing practices) for dietary supplements. FDA inspected the manufacturing facility in early August 2010 and noted several “serious” violations of the cGMPs, which cause the cited dietary supplements—several types of Revival Soy Pro Water Mix—to be adulterated.

The Supreme Court’s Matrixx Initiatives Decision

On March 22, 2011, a unanimous Supreme Court affirmed a Court of Appeals decision allowing a class action suit alleging Matrixx Initiatives defrauded investors by failing to disclose the potential existence of serious adverse events (SAEs) caused by its zinc gluconate homeopathic drug, Zicam Cold Remedy. Matrixx argued federal securities laws did not require the disclosure of SAEs unless they were reported to the company at a rate that reached statistical significance. The Supreme Court, however, refused to establish such a bright-line rule, and instead held that disclosure was required under any circumstances where “a reasonable investor” would find the existence of potential SAEs relevant to the decision of whether to purchase securities.