CDER Suggests Limiting the Use of Certain Phthalates as Excipients Due to Health Risks

The U.S. Food and Drug Administration (FDA) has announced a guidance representing the Center for Drug Evaluation and Research’s (CDER’s) current thinking on exposure to the Phthalates esters, dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). The guidance recommends that the pharmaceutical industry avoids using these substances in all prescription and non- prescription CDER-regulated drugs due to its potential health risk to humans.

Phthalates ester, a synthetic chemical found in pharmaceutical products, is used as a plasticizer for enteric-coatings of solid oral drugs. Phthalates are also found in softeners of plastics, solvents in perfumes, additives in nail polish, lubricants, and insect repellents.

Extensive studies of phthalates have been conducted on laboratory animals, in which DBP and DEHP have shown to be developmental and reproductive toxicants. These phthalates are believed to also be endocrine-disrupting in humans. Observational human studies have also suggested an association between exposure to DBP and DEHP and developmental and reproductive effects.
 
Humans are exposed to phthalates through inhalation, ingestion, and absorption through the skin. Exposure to these phthalates is especially threatening to infants and pregnant women.
 
“While there is evidence to support that DBP and DEHP exposure from pharmaceuticals presents a potential health risk to humans, the CDER has announced that there are safer alternatives available,” states Diane Miskowski, MPH Business Development Manager at EMSL Analytical. “EMSL, the nation’s leading environmental testing laboratory, has FDA registered, DEA licensed, and ISO17025 compliant laboratories located throughout the United States that provide advanced testing to detect DBP and DEHP in pharmaceutical samples.”

For more information on EMSL’s testing services, please contact EMSL at (800) 220-3675, visit www.EMSL.com, or email  info@EMSL.com .
 
About EMSL Analytical, Inc.
EMSL Analytical is the nation’s leading testing laboratory with over 30 locations throughout the United States and Canada. We are a nationally recognized and locally focused provider specializing in consumer product, environmental, industrial hygiene, indoor air quality, microbiology, radon, food, and materials testing services to professionals and the general public. Please visit our website for a complete listing of accreditations from leading organizations, as well as state and federal regulating bodies.

Contact Information

Joseph Frasca

Senior Vice President of Marketing

EMSL Analytical

(1) 1-800-220-3675

jfrasca@emsl.com