FAQ: Teratology Screened - What Does it Mean?

Simply stated, teratology screened products guard against questionable ingredients during pregnancy.  For decades, medical science has known that small amounts of skin care ingredients are absorbed into the bloodstream.  This natural process explains why so many medications are now prescribed as topical creams or patches.  The total absorption of a topical ingredient depends on various factors such as surface area covered, duration of exposure, frequency of reapplication, skin thickness, temperature/humidity levels, etc.  During pregnancy, most absorbed chemicals will pass directly into the fetal circulation where they can potentially affect the baby’s development.  

The average woman puts over 200 ingredients on her skin each day as part of her cleansing and beauty routine, and it is difficult to know which may be harmful to the fetus or at what dose.   At Belli, we believe that pregnancy deserves a higher safety standard—one that carefully monitors the published medical literature and errs on the side of caution.  All of our Belli Pregnancy products are teratology screened.

The process for a product to be teratology screened begins with a comprehensive search of the published medical literature to see if an ingredient has ever been linked to a birth defect, miscarriage, or other harmful effect during pregnancy.  Searches are repeated on an ongoing basis to capture all the latest information.  A list of the databases and reference books used includes:

MEDLINE is the premiere biomedical database produced by the National Library of Medicine and contains over 16 million articles from 5000 international biomedical journals, from 1950 to the present. 

TOXLINE is a comprehensive database produced by the U.S. National Library of Medicine and contains more than two million records that cover adverse drug reactions, carcinogenesis, drug evaluation, mutagenesis, pollution, pesticides, herbicides, radiation, teratogenesis, and all other aspects of toxicology from pre-1950 to the present. 

DART (Developmental and Reproductive Toxicology) is a bibliographic database on the National Library of Medicine’s Toxicology Data Network, which covers teratology and other aspects of developmental and reproductive toxicology and contains over 100,000 published references. 

TERIS (Teratogen Information System) is a database of chemical agent summaries based on a thorough review of published clinical and experimental literature.  Each summary includes a risk assessment derived by consensus of an Advisory Board comprising nationally-recognized authorities in clinical teratology.

LACTMED, part of the National Library of Medicine’s Toxicology Data Network (TOXNET), is a database of drugs and other chemicals to which breastfeeding mothers may be exposed. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. 

REPROTOX is an information system developed by the Reproductive Toxicology Center which contains summaries on the effects of medications, chemicals, infections, and physical agents on pregnancy, reproduction, and development.  

Catalog of Teratogenic Agents- Eleventh Edition (Shepard, 2004) is a comprehensive reference work that presents information on teratogenic agents, emphasizing human data and covering pharmaceuticals, chemicals, environmental pollutants, food additives, household products, and viruses.   Also included are overviews of recent literature on clinical and experimental teratology, including important Japanese literature not easily available to English-language researchers.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risks- Eighth Edition (Briggs et al., 2008) provides practical, reliable information on more than 1,000 drugs that may be used by pregnant and lactating women. The recommendations help readers interpret animal and human pregnancy data to assess potential human risk when there are human data or the human data are limited or not available.

Chemically Induced Birth Defects- Third Edition (Schardein, 2000) addresses over 4100 drugs and chemicals in current use that cause malformations and congenital anomalies in the human fetus-- comprehensively reviewing experimental studies in animals and clinical data on human development, primarily in the organogenesis period.

Once the search process is complete, we then have to decide which screening criteria to use.  For example, what if 3 studies show a harmful effect during pregnancy but 5 show no evidence of harm?  What if some of the studies were done on humans and others on animals?  High versus low doses?  Topical versus oral absorption?  

Rather than subjectively try to weigh the results of different or conflicting studies, we use a zero-tolerance standard that excludes ingredients if there is even a single published study showing evidence of harm during pregnancy— in either animals or humans, at any dose, and through any method of absorption.