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Will your dietary supplements be safer in the future? In response to the numerous safety issues associated with dietary supplements, the FDA is proposing new rules, which, if adopted as proposed, would establish new standards or "current good manufacturing practices" (CGMPs). The goal is to help reduce the risks associated with adulterated or misbranded dietary supplement products.
More about the new proposed rule:
The proposed rule would establish industry-wide standards necessary to ensure that dietary supplements are manufactured consistently as to identify, purity, quality, strength, and composition.
The minimum standards include requirements on the design and construction of physical plants that facilitate maintenance, cleaning, and proper manufacturing operations, for quality control procedures, for testing final product or incoming and in process materials, for handling consumer complaints, and for maintaining records.
Examples of product quality problems the CGMPs will help prevent are: superpotent, subpotent, wrong ingredient, drug contaminant, other contaminant (e.g., bacteria, pesticide, glass, lead), color variation, tablet size or size variation, under-filled containers, foreign material in a dietary supplement container, improper packaging, and mislabeling.
Consumer Benefits
Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled. The proposed rule would not limit consumers' access to dietary supplements but, instead, would give consumers greater confidence that the dietary supplement they use will have the identity, purity, quality, strength, and composition that is claimed on the label.
Examples of product quality problems that the proposed rule would help prevent are:
dietary supplements that contain much more than listed on the label and may be harmful
dietary supplements that contain less ingredients than listed on the label
wrong ingredient,
drug contaminant,
other contaminant (e.g., bacteria, pesticide, glass, lead),
foreign material in a dietary supplement container,
improper packaging, and
mislabeled
Under the newly proposed rule, manufacturers would be responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading. With this proposed rule, FDA will have the authority to determine standards that firms should apply in production and labeling. Stay tuned for future of issues of SNaC Bytes for more information.
More about the new proposed rule:
The proposed rule would establish industry-wide standards necessary to ensure that dietary supplements are manufactured consistently as to identify, purity, quality, strength, and composition.
The minimum standards include requirements on the design and construction of physical plants that facilitate maintenance, cleaning, and proper manufacturing operations, for quality control procedures, for testing final product or incoming and in process materials, for handling consumer complaints, and for maintaining records.
Examples of product quality problems the CGMPs will help prevent are: superpotent, subpotent, wrong ingredient, drug contaminant, other contaminant (e.g., bacteria, pesticide, glass, lead), color variation, tablet size or size variation, under-filled containers, foreign material in a dietary supplement container, improper packaging, and mislabeling.
Consumer Benefits
Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled. The proposed rule would not limit consumers' access to dietary supplements but, instead, would give consumers greater confidence that the dietary supplement they use will have the identity, purity, quality, strength, and composition that is claimed on the label.
Examples of product quality problems that the proposed rule would help prevent are:
dietary supplements that contain much more than listed on the label and may be harmful
dietary supplements that contain less ingredients than listed on the label
wrong ingredient,
drug contaminant,
other contaminant (e.g., bacteria, pesticide, glass, lead),
foreign material in a dietary supplement container,
improper packaging, and
mislabeled
Under the newly proposed rule, manufacturers would be responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading. With this proposed rule, FDA will have the authority to determine standards that firms should apply in production and labeling. Stay tuned for future of issues of SNaC Bytes for more information.