FDA COMPLIANCE for the DIETARY SUPPLEMENT INDUSTRY

GMP Terms Defined

 

Adulteration: Unintentional product adulteration applies to products that may have become contaminated due to lack of control of the manufacturing process, or due to insanitary conditions that may have existed in the manufacturing, storage, or distribution of a dietary supplement. Unintentional adulteration is initially considered a regulatory violation, while intentional adulteration is a criminal act.

CAPA: Abbreviation for Corrective Actions / Preventive Actions particularly as related to remediation of GMP violations or non-compliance with cGMP regulations.

DSHEA: The 1994 Dietary Supplement Health & Education Act. GMP regulations are enforced by FDA on all dietary supplements manufactured or sold in the US, and intended to protect consumer safety.

FDA: The U.S. Food & Drug Administration, which is responsible for enforcing regulations that seek to protect consumer health and safety. FDA regulations exist for foods, drugs, cosmetics, medical devices, and dietary supplements.

FTC: The U.S. Federal Trade Commission is responsible for enforcing regulations that ban false or misleading product claims or advertising on consumer products, including dietary supplements.

GMP: Good Manufacturing Practices, as defined in the DSHEA and the Food, Drug, and Cosmetic Act as amended. cGMP refers to “current” GMPs that are required to maintain a state of control of the quality & safety of dietary supplements from ingredient to consumer.

Quality: Refers to written dietary supplement specifications for identity, purity, strength, composition, and limits on contaminants, and whether a product has been manufactured, packaged, labeled, and held under conditions to prevent adulteration as defined by FDA regulations.

Quality control: A plan or system to ensure the quality of a dietary supplement.

Responsible Person: A legal term under FDA regulations which refers to the company whose name appears on the label of a dietary supplement marketed in the US.

Serious adverse event (SAE): is a type of consumer reaction or adverse event that requires mandatory reporting to the FDA within 15 days.
An adverse event complaint ascends to SAE status when ANY of the following are alleged:

  1. Death or life-threatening episode, inpatient hospitalization, persistent or significant disability or incapacity, birth defect or congenital anomaly, medical attention or surgery judged necessary to prevent death, illness, or injury.

SOP: A Standard Operating Procedure is a written document which describes procedures required to establish or maintain FDA GMP compliance within company operations.