01.16.24
Jay Sirois, PhD, vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association (CHPA), along with experts from CHPA member companies Bayer, Nestlé Health Science, Reckitt, ADM, BiomEdit, Sanofi, Haleon, and Bausch & Lomb published an article highlighting best safety practices in the manufacturing of dietary supplements. The article was published by Regulatory Toxicology and Pharmacology.
“As the use of dietary supplements continues to increase in the United States, manufacturers should understand the importance of implementing a robust approach to establishing safety for all supplement ingredients, components, and finished products,” said Sirois. “This peer-reviewed publication provides a comprehensive overview of safety assessment principles to consider when supporting the safety of dietary ingredients or supplements. Our paper reviews ingredient safety principles through the cycle of a finished dietary supplement product, from the evaluation of dietary ingredients to the manufacturing process and monitoring of adverse events.”
“Manufacturers of dietary supplements are responsible for ensuring that they have evidence supporting the safety of their products, and must follow regulatory requirements for manufacturing, packaging, labeling, and regularly monitor adverse events. This paper provides a helpful overview of safety assessment parameters companies can employ, in order to better ensure that safe products, backed by responsible science, are provided to consumers.”
The paper begins with introductory definitions, as well as premarket considerations regarding what FDA requires of manufacturers to demonstrate that an ingredient is safe ahead of manufacture. This includes: preclinical data; product specifications; regulatory status; allergens; colors and additives; nutritional information; heavy metal impurities; residual solvents; organic/non-organic specifications; pesticide residues; bioengineered ingredient status; Proposition 65 compliance; GMP compliance; and aflatoxins/pyrrolizidine alkaloids. Following this, there are several considerations regarding ingredient dosage to overview.
The paper then provides an overview of premarket rules specific to the United States, and then goes over special safety considerations for dietary ingredient categories, including vitamins/minerals, botanicals, “biotics,” synthetics, and other ingredients.
Then, best practices regarding other dietary supplement components, such as excipients, flavors, and colors/dyes are discussed.
Then, a series of recommendations regarding finished product assessment is broken down into recommendations specific to safety-related claims, labeling, overages, packaging, stability, and heavy metals, residual solvents, adulterants, and contaminants.
Finally, the authors go over some key objectives to keep in mind when it comes to post-market surveillance.
“As the use of dietary supplements continues to increase in the United States, manufacturers should understand the importance of implementing a robust approach to establishing safety for all supplement ingredients, components, and finished products,” said Sirois. “This peer-reviewed publication provides a comprehensive overview of safety assessment principles to consider when supporting the safety of dietary ingredients or supplements. Our paper reviews ingredient safety principles through the cycle of a finished dietary supplement product, from the evaluation of dietary ingredients to the manufacturing process and monitoring of adverse events.”
“Manufacturers of dietary supplements are responsible for ensuring that they have evidence supporting the safety of their products, and must follow regulatory requirements for manufacturing, packaging, labeling, and regularly monitor adverse events. This paper provides a helpful overview of safety assessment parameters companies can employ, in order to better ensure that safe products, backed by responsible science, are provided to consumers.”
The paper begins with introductory definitions, as well as premarket considerations regarding what FDA requires of manufacturers to demonstrate that an ingredient is safe ahead of manufacture. This includes: preclinical data; product specifications; regulatory status; allergens; colors and additives; nutritional information; heavy metal impurities; residual solvents; organic/non-organic specifications; pesticide residues; bioengineered ingredient status; Proposition 65 compliance; GMP compliance; and aflatoxins/pyrrolizidine alkaloids. Following this, there are several considerations regarding ingredient dosage to overview.
The paper then provides an overview of premarket rules specific to the United States, and then goes over special safety considerations for dietary ingredient categories, including vitamins/minerals, botanicals, “biotics,” synthetics, and other ingredients.
Then, best practices regarding other dietary supplement components, such as excipients, flavors, and colors/dyes are discussed.
Then, a series of recommendations regarding finished product assessment is broken down into recommendations specific to safety-related claims, labeling, overages, packaging, stability, and heavy metals, residual solvents, adulterants, and contaminants.
Finally, the authors go over some key objectives to keep in mind when it comes to post-market surveillance.
