The unapproved drug centrophenoxine (meclofenoxate) in cognitive enhancement dietary supplements

Abstract

Introduction

Centrophenoxine (meclofenoxate) is prescribed in China and elsewhere to treat a variety of conditions including alcoholism and dementia, but the US Food and Drug Administration has not approved the drug for any indication. We designed our study to determine the presence and quantity of centrophenoxine in dietary supplements sold over-the-counter in the US.

Methods

Supplements were included in our study if the label included (a) the term “dietary supplement” and (b) “centrophenoxine” as a declared ingredient. Supplements were purchased online, and powder from each dietary supplement product was reconstituted in methanol and analyzed using ultra high-performance liquid chromatography.

Results

Seven products were analyzed. Centrophenoxine was present in all products in dosages ranging from 79 to 251 mg per serving. Consumers following the maximum recommended daily intake on the label would be exposed to 237 to 752 mg of centrophenoxine per day. Only 1 of 7 products (14%) listed a quantity of centrophenoxine on the label within ±10% of the actual amount.

Conclusion

Clinicians should be aware and advise patients that cognitive enhancement supplements may contain unapproved and prohibited drugs.

Keywords:

• Dietary supplement
• public health
• nootropics

Acknowledgements

The authors wish to thank Patricia Redd, MLS of Cambridge Health Alliance and Paul Bain, PhD of Harvard Medical School for their expert assistance in obtaining obscure references; and John Travis, BS of NSF International for thoughtful comments on a prior draft of the manuscript.

Disclosure statement

P.A. Cohen has received research support from Consumers Union and PEW Charitable Trusts. I. Khan reported receiving grants from the US Food and Drug Administration, the National Institute of Health, and the US Department of Agriculture. I. Khan is also the coordinator of the International Conference on the Science of Botanicals which receives support for conference‐related expenses from multiple supplement‐related companies. B. Avula reports no disclosures relevant to the manuscript.