What is a nutraceutical?
A Nutraceutical is a pharmaceutical-grade and standardized nutrient. In the US, “nutraceuticals” do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.
They are in essence 1 step below a pharmaceutical. Regulations are often convoluted and confusing.
The nutraceutical industry is ever changing. For the past 10 years ShelleyRae has navigated the Health Canada and FDA waters. From Health Canada’s Natural Health Products Registry to daily compliance and quality assurance.
Do you have a product you're trying to get approved for the US or Canadian Markets?
The term “nutraceuticals” is often interchanged with “functional foods” even though there are subtle differences between the two.
Nutraceuticals are “naturally derived bioactive compounds that are found in foods, dietary supplements and herbal products, and have health promoting, disease preventing, or medicinal products” (Ref: Nutraceuticals Institute)
Functional foods are foods which contain an ingredient that gives that food health-promoting properties over and above its usual nutritional value, for example, probiotic yogurts.