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

QUALITY BY DESIGN 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 very limited compliance. 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."

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