20
Food and medicine regulation is intended to protect consumer’s health, increase
economic viability, and harmonize well-being and the engendering fair trade on
foods within and between nations. If indeed an assertion was made that implied
medicinal benefit concerning a herbal nutraceutical product, the product would be
required to conform with the regulatory requirements for medicinal products, in
respect of safety, efficacy, and quality testing and marketing authorization procedures (Pandey et al. 2010). For herbal nutraceutical industries, two challenges are
apparent; regulatory uncertainty and integrity of labeling claims.
For years, the Food and Drug Administration (FDA) regulated dietary supplements as foods to ensure that they were safe and wholesome and also ensure that the
labeling was truthful and not deceptive. The FDA may establish good manufacturing practices for nutraceuticals as long as these regulations are molded after the less
strict regulations for foods as divergent to those for drugs.
The Indian government in 2006 passed Food Safety and Standard Act to incorporate and streamline the many regulations covering foods, dietary supplements
and nutraceuticals. The act recommended the creation of the Food Safety and
Standards Authority (FSSA). The FSSA was expected to unify the existing eight
laws i.e. harmonization of the laws to align with the international regulations and
science-based standards, maintain clarity and uniformity on novel food areas and
also help curb corruptions.
Importance of Herbal Nutraceutical Regulation:
(I) Allows better legal security and more predictable environment.
(II) Supports innovation (food, herbal and drink products).
(III) Prevents imbalanced competition from manufacturers using untruthful or misleading claims.
(IV) If confident claims cannot be made, the regulation does not gratify anyone to
make negative claims about the product.
2.3.2 Global Market/Demands of Herbal Nutraceutical
The nutraceutical industry is divided into two main segments which include dietary
supplements and herbal/natural products. In the Global market, nutraceutical has
become a multi-billion dollar industry with about USD 117 billion (INR 5148 billion) as estimated cost of investment (Rishi 2006). According to a report, India is
growing at 21% per annum in her total market for nutraceuticals. As of 2014, it
appreciated at INR 44bn (€621 m), but could be worth more than INR 95bn in the
following 4 years (http://www.horiba.com/scientific/products/particle/characterization/applications/nutraceuticals). In Canada, the nutraceutical industry has an estimated potential to grow up to 50 billion US dollars. According to the nutrition
business journal in 2017, the United States of America (USA) is the largest market
in the world followed by Japan which has a steady average growth rate of 9.6%
per annum. The nutrition business journal generally classified the contributions of
O. K. Nwosu and K. I. Ubaoji
Food and medicine regulation is intended to protect consumer’s health, increase
economic viability, and harmonize well-being and the engendering fair trade on
foods within and between nations. If indeed an assertion was made that implied
medicinal benefit concerning a herbal nutraceutical product, the product would be
required to conform with the regulatory requirements for medicinal products, in
respect of safety, efficacy, and quality testing and marketing authorization procedures (Pandey et al. 2010). For herbal nutraceutical industries, two challenges are
apparent; regulatory uncertainty and integrity of labeling claims.
For years, the Food and Drug Administration (FDA) regulated dietary supplements as foods to ensure that they were safe and wholesome and also ensure that the
labeling was truthful and not deceptive. The FDA may establish good manufacturing practices for nutraceuticals as long as these regulations are molded after the less
strict regulations for foods as divergent to those for drugs.
The Indian government in 2006 passed Food Safety and Standard Act to incorporate and streamline the many regulations covering foods, dietary supplements
and nutraceuticals. The act recommended the creation of the Food Safety and
Standards Authority (FSSA). The FSSA was expected to unify the existing eight
laws i.e. harmonization of the laws to align with the international regulations and
science-based standards, maintain clarity and uniformity on novel food areas and
also help curb corruptions.
Importance of Herbal Nutraceutical Regulation:
(I) Allows better legal security and more predictable environment.
(II) Supports innovation (food, herbal and drink products).
(III) Prevents imbalanced competition from manufacturers using untruthful or misleading claims.
(IV) If confident claims cannot be made, the regulation does not gratify anyone to
make negative claims about the product.
2.3.2 Global Market/Demands of Herbal Nutraceutical
The nutraceutical industry is divided into two main segments which include dietary
supplements and herbal/natural products. In the Global market, nutraceutical has
become a multi-billion dollar industry with about USD 117 billion (INR 5148 billion) as estimated cost of investment (Rishi 2006). According to a report, India is
growing at 21% per annum in her total market for nutraceuticals. As of 2014, it
appreciated at INR 44bn (€621 m), but could be worth more than INR 95bn in the
following 4 years (http://www.horiba.com/scientific/products/particle/characterization/applications/nutraceuticals). In Canada, the nutraceutical industry has an estimated potential to grow up to 50 billion US dollars. According to the nutrition
business journal in 2017, the United States of America (USA) is the largest market
in the world followed by Japan which has a steady average growth rate of 9.6%
per annum. The nutrition business journal generally classified the contributions of
O. K. Nwosu and K. I. Ubaoji