**Acknowledgements**

for Drug Evaluation and Research (CDER) and a drug identification number (DIN) before it

In Canada, the term "cosmeceutical" (used to describe a cosmetic product with pharmaceuti‐ cal-like benefits) is not employed by Health Canada [122]. Therefore cosmeceuticals fall under either cosmetics or drugs (depending on the claims made and/or the composition of the product) and are subject to the provisions of the Food and Drugs Act and its Cosmetic Regulations regarding composition, safety, labeling and advertising and they are subject to the provisions of the Consumer Packaging and Labeling Act and Regulations [122]. The three most significant features of the Canadian cosmetic regulatory system are mandatory notifica‐ tion of all cosmetic products, safety of ingredients and products, and product labeling [122]. According to Health Canada, a "cosmetic" is defined as *"any substance or mixture of substan‐ ces, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin,*

In Europe, EMA guidelines place a clear demarcation between drugs and cosmetics, whereby a cosmetic is a product that is to be applied topically with an intended cosmetic function and products cannot fall under both categories, unlike in the US [116]. On November 30th (2009), the new Cosmetic Products Regulation, EU Regulation 1223/2009 was adopted, replacing the Cosmetics Directive [123]. With the new Cosmetics Regulation, Europe claims to have a robust, internationally recognized regime, which reinforces product safety taking into consideration the latest technological developments [123]. Most of the provisions of this new regulation will

A natural product or secondary metabolite is a pharmacologically or biologically active chemical compound or substance, which is found in nature and produced by a living organism. The lengthy process of natural products evolution has resulted in optimal interactions with biological macromolecules and targets. Historically, natural substances have been the most productive source of active compounds and chemical lead structures. Natural products have traditionally provided a large fraction of the drugs in use today and millions of terrestrial and marine plants, organisms and microorganisms provide an immense resource to discover unprecedented novel bioactive scaffolds. These have the potential to serve as medical treat‐ ments or templates for new therapeutics and may be suitable for production via a synthetic routes or in a heterologous system like *E. coli.* About half of the agents in today's arsenal of marketed drugs are derived from biological sources with the large majority being based on terrestrial natural product scaffolds. Approximately 50% of the new drugs introduced since 1994 were either natural products or derived from natural products. As of today, only a very

*hair or teeth and includes deodorants and perfumes"* [122].

24 Using Old Solutions to New Problems - Natural Drug Discovery in the 21st Century

be applicable as of July 11th, 2013 [123].

can be sold.

*5.3.1.2. Canada*

*5.3.2. European Union*

**6. Conclusion**

Funding for the publication of this chapter was provided by the School of Business Adminis‐ tration and the Centre for Health and Biotech Management Research, University of Prince Edward Island, Charlottetown, PE, Canada. We are grateful to BCC Research (Wellesley, MA, USA) for providing us with applicable sections from their 2013 market report, namely "Botanical and Plant-derived Drugs: Global Markets".

### **Author details**

Juergen Krause1\* and Gailene Tobin2

\*Address all correspondence to: jukrause@upei.ca

1 School of Business Administration and Centre for Health and Biotech Management Re‐ search, University of Prince Edward Island, Charlottetown, PE, Canada

2 Department of Biomedical Sciences, University of Prince Edward Island, Charlottetown, PE, Canada

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