GHB, GBL, AND BD:
Neither Dietary Supplements Nor Safe for Humans

WASHINGTON, DC, January 11, 2001— The publication of eight cases of serious adverse events associated with the use of 1,4-butanediol (BD) in today’s New England Journal of Medicine reinforces the urgency of removing this substance and related compounds–gamma-hydroxybutyrate (GHB) and gamma-butyrolactone (GBL)–from the market. The Council for Responsible Nutrition (CRN) reaffirms its long held position that GHB, GBL, and BD are unsafe substances and not legitimate dietary supplements.

"CRN does not regard these products as legitimate dietary supplements, and we support all legal efforts to eliminate them from trade immediately," stated John Cordaro, president and chief executive officer of CRN. "The Dietary Supplement Health and Education Act (DSHEA) permits the sale of dietary supplements only under the condition that they are reasonably expected to be safe," continued Mr. Cordaro, "and the Act gives the Food and Drug Administration (FDA) full authority to remove unsafe products."

CRN and the other dietary supplement trade associations vigorously supported FDA’s 1999 decision that GBL was not a safe dietary ingredient under DSHEA and also supported the subsequent product recall. That decision should logically apply to GBL precursors, such as BD. FDA has issued a public warning against all these related compounds.

The Federal Trade Commission (FTC) has taken action against companies that misrepresent the safety of their products, including marketers of these substances. Mr. Cordaro emphasized that "CRN will continue to work cooperatively with any and all government agencies to protect consumers from GHB, GBL, BD and related compounds."

The Council for Responsible Nutrition (CRN) was founded in 1973 and represents approximately 100 companies in the dietary supplement industry, including bulk ingredient suppliers as well as finished product manufacturers. Members include manufacturers of national brands of dietary supplements as well as several large manufacturers of the store brands available in most supermarkets, drug stores, health food stores, and super stores. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.