In April 2012, the Food and Drug Administration (FDA) will begin regulating the level of di(2-ethylhexyl)phthalate (DEHP) in bottled water. Manufacturers will be required to annually monitor their finished bottled water products and source water for DEHP in order to maintain compliance with current good manufacturing practice (cGMP) regulations.

Read more about the allowable levels for DEHP in bottled water…

by Brian Lewis, Ph. D

On January 15, 2010, the Food and Drug Administration (FDA) reversed its position that exposure to bisphenol-A (BPA) is not harmful, stating that they now “have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children”.¹ In the same report, the FDA voiced their support for the food and beverage container industry to halt production of baby bottles and feeding cups in the U.S. that contain BPA.

The FDA’s current position on BPA follows a 2008 draft report by the agency that claimed the no observable adverse effect level (NOAEL) of 5 mg/kg body weight/day was “an adequate margin of safety … for BPA at current levels of exposure from food contact uses,” and that the 2.42 μg/kg body weight/day and 0.185 μg/kg body weight/day exposure levels found in infants and adults, respectively, was safe.² However, when that draft report was submitted to a seven-member panel of experts for peer review, the panel refuted the FDA’s position, stating that “the available qualitative and quantitative information … provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as ‘adequate’ are, in fact, inadequate”.³

Read more about Bisphenol-A…

The United States Environmental Protection Agency (EPA) will soon release its response to a 2006 National Academy of Sciences (NAS) report recommending changes to the EPA’s 2000 draft assessment of the risks posed by 2,3,7,8 Tetrachlorodibenzo-p-Dioxin.

Dioxins are environmental contaminants according to the Food and Drug Administration’s (FDA) website (September 2009). Most human dioxin exposure, however, occurs through the diet, with more than 95% coming through dietary intake of animal fats. Dioxins enter the food chain primarily in an air-to-leaf/soil-to-animal route.

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Pharmaceutical manufacturers may face various challenges when attempting to meet the United States Pharmacopeia (USP) requirements for residual solvents (volatile organic chemicals).

Residual solvents in pharmaceuticals are trace level impurities of volatile organic compounds in final products or excipients. In general, residual solvents originate from manufacturing processes related to the preparation of drug products. They can also form during product packaging and storage.

Read more about USP 467…

For years, dietary supplements have been scrutinized by the media for being marketed as “snake-oil” cure-alls, potentially containing components considered harmful to consumers. Under-regulation by the Food and Drug Administration (FDA) lead to concerns that these products did not fall under the same regulatory requirements as pharmaceuticals. Until now.

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