QUALITY
Quality is a concern with any product. It is especially
important with concentrated ingested products such as medications, vitamins
and nutritional supplements. Maximum D3 is manufactured, packaged and
warehoused in the USA in FDA registered facilities.
CAPSUGEL Greenwood,
SC USA
JLM PHARMATECH Seymour,
IN USA
PRO-PHARMA LLC Kirksville, MO USA
The United States Pharmacopeia sets USP standards which are the accepted international
standards for drug quality. These standards address purity, content uniformity,
disintegration and the requirement for ongoing analysis. Note that pharmaceutical
quality is not a regulated descriptor and, therefore, does not ensure a USP product.
USP standards do not exist for most nutritional supplements or for many vitamin
preparations; even when published standards exist, there is usually no
legal requirement that they be followed. Regrettably this
has led to a great many ill advised and poorly formulated products
being marketed in the United States. These considerations and our conviction
that oral cholecalciferol supplementation is an important requirement
for health in sun deprived populations led to the decision to follow
the most stringent standards for our product. Maximum D3 conforms to USP standards <581> for purity, <2091> for
weight variation, and <2040> for disintegration and dissolution
and conforms to USP standards for ingredients.
Here is an excerpt from an FDA statement addressing
these issues, and links for more detail:
Quality Products
“Poor manufacturing practices are not unique to dietary supplements,
but the growing market for supplements in a less restrictive regulatory
environment creates the potential for supplements to be prone to quality-control
problems. For example, FDA has identified several problems where some
manufacturers were buying herbs, plants and other ingredients without
first adequately testing them to determine whether the product they
ordered was actually what they received or whether the ingredients
were free from contaminants.
To help protect themselves, consumers should:
Look for ingredients in products with the U.S.P. notation, which indicates the
manufacturer followed standards established by the U.S. Pharmacopoeia.
Realize that the label term "natural" doesn't guarantee that a product
is safe. "Think of poisonous mushrooms," says Elizabeth Yetley, Ph.D.,
director of FDA's Office of Special Nutritionals. "They're natural."
Consider the name of the manufacturer or distributor. Supplements
made by a nationally known food and drug manufacturer, for example,
have likely been made under tight controls because these companies
already have in place manufacturing standards for their other products.
Write to the supplement manufacturer for more information. Ask the
company about the conditions under which its products were made.”
- Links -
http://www.cfsan.fda.gov/~dms/fdsupp.html
http://www.fda.gov/fdac/features/1998/598_guid.html
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