Planta Med 2012; 78 - PL1
DOI: 10.1055/s-0032-1321335

A practical guide to the safe use of natural products in consumer products

NL Booth 1, CL Kruger 1, AW Hayes 1, 2
  • 1Spherix Consulting, Incorporated, 6430 Rockledge Drive, Suite 503, Bethesda, MD 20817, USA
  • 2Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115

Natural products have endless application possibilities in consumer products. Examples include: food or dietary supplement ingredients; preservatives; sweeteners; pre- and probiotics; functional additives such as emulsifiers, clarifying agents, processing aids in manufacturing, and “active” packaging; cosmetics; personal care products; drugs; and more. With use of a natural product comes a concomitant consumer exposure to the molecule, fraction, extract, or organism. This exposure is addressed by scientific means to ensure the safety of the substance for the end user. Natural products for use in consumer products will be subjected to a scientific safety assessment. A safety assessment of a natural product will typically consider the following issues: 1) identity and composition of the substance, 2) likely or probable contaminants/co-purifying molecules/reaction byproducts (for synthetically or semi-synthetically produced natural products), 3) consistency of composition of the substance as demonstrated over time across non-consecutive lots, 4) dose, 5) route of exposure, 6) and anticipated duration of exposure to the substance. Pharmacognosists are well-equipped to play a key role in carrying out safety assessments of natural products. Many common scientific “data gaps” discovered during safety assessments can be filled by the application of pharmacognostic techniques or tools. Example data gaps will be presented, and the suggested means to fill them will be discussed. Recommendations for increasing the success of regulatory submissions will be highlighted as relevant.