FDA Proposes Labeling and Manufacturing Standards Dietary Supplements
FDA's Proposed Rule
- FDA's proposed rule, if adopted as proposed, would establish new standards
or "current good manufacturing practices" (CGMPs) to help reduce
risks associated with adulterated or misbranded dietary supplement products.
- 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 inprocess 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.
- The proposed CGMPs would apply to all firms that manufacture, package, or
hold dietary ingredients or dietary supplements, including those involved
with the activities of testing, quality control, packaging and labeling, and
distributing them. The proposed regulations also would apply to both domestic
firms and foreign firms that manufacture, package, or hold dietary ingredients
and dietary supplements for distribution into the U.S.
- FDA is soliciting comments from the public and industry on this proposal.
Written comments will be received until 90 days after the date of publication
in the Federal Register.
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.
The proposed rule, if it becomes final as proposed, 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.
- The proposed rule addresses the quality of manufacturing processes for dietary
supplements and the accurate listing of supplement ingredients. It does not
limit consumers' access to dietary supplements, or address the safety of their
ingredients, or their effects on health when proper manufacturing techniques
are used.
- Last week, to address concerns about the safety of ephedra, FDA announced
a proposed warning label, issued warning letters on certain ephedra marketing
practices, and announced a public comment period regarding potential further
restrictions on ephedra products.
- This proposed regulation follows FDA's consumer initiative announced last
December intended to improve FDA's policies on providing information about
health consequences of food and dietary supplements and to increase enforcement
efforts to prevent misleading health claims made by certain dietary supplement
manufacturers.
Manufacturers
- Under DSHEA, manufacturers have an essential responsibility to substantiate
the safety and efficacy of the dietary ingredients they use in manufacturing
a product.
- Dietary supplements have been recalled because of microbiological, pesticide,
and heavy metal contamination - adulteration that might be prevented through
a uniform set of manufacturing requirements.
- The CGMPs will assist manufacturers in producing unadulterated and properly
labeled dietary supplements and will provide a basis for consumers to have
confidence that the dietary supplement products they purchase contain the
identity, purity, quality, strength, and composition that the label claims.
- Manufacturers are also 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.
- Under the CGMP proposed rule, manufacturers would be required to:
- Employ qualified employees and supervisors;
- Design and construct their physical plant in a manner to protect dietary
ingredients and dietary supplements from becoming adulterated during manufacturing,
packaging, and holding;
- Use equipment and utensils that are of appropriate design, construction,
and workmanship for the intended use;
- Establish and use a quality control unit and master manufacturing and
batch production records;
- Hold and distribute materials used to manufacture, package, and label
dietary ingredients, dietary supplements, and finished products under
appropriate conditions of temperature, humidity, light, and sanitation
so that their quality is not affected.
- Keep a written record of each consumer product quality complaint related
to CGMPs; and
- Retain records for 3 years beyond the date of manufacture of the last
batch of dietary ingredients or dietary supplements.
- 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
- Manufacturers are also 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.
Background
- FDA has found that manufacturing problems have been associated with dietary
supplements. Products have been recalled because of microbiological, pesticide,
and heavy metal contamination and because they do not contain the dietary
ingredients they are represented to contain or they contain more or less than
the amount of the dietary ingredient claimed on the label.
- In recent years, several private sector laboratories analyses found that
a substantial number of dietary supplement products analyzed did not contain
the amount of dietary ingredients claimed in their product labels.
- The Dietary Supplement Health and Education Act of 1994 provide the Secretary
of Health and Human Services, and the FDA by delegation, the express authority
to issue regulations on dietary supplement CGMPs.
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Press Release
Proposed Rule (PDF 551
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