News

The following briefing comes from International media, FDA press releases and their own documents. It concerns new rules established and implemented today by the FDA requiring the manufacturing and labeling of dietary supplements to be in compliance with cGMP (Current Good Manufacturing Practices).

This is a detailed briefing and, while it makes sense from a “consumer protection viewpoint,” it also conveniently and discretely opens the door to the movement to reclassify (natural) dietary supplements as drugs and medicines and is, perhaps, one of the US’s biggest steps moving toward the exceedingly restrictive EU Food Supplements Directives and CODEX Alimentarius’ aligned and forthcoming guidelines worldwide. Both of which are geared to the elimination of many existing vitamin forms as well as natural herbs replacing them with patentable drug versions.

We have provided the FDA’s released and published information rather then tell you what to think about it. Read the data. Go to the WINHS web site for data of comparable magnitude so you can see how to put it into perspective.  

Copies of the actual documents are possible through hyperlinks where we have included them.

If you would like to learn more about the international and legislative efforts to eliminate, restrict and significantly regulate natural food supplements (vitamins and herbs), please go to www.winhs.org.

If you would like to help, log in to become a member. It is free and your assistance is welcome.

 

22 June 2007

FDA issues supplement rules

The U.S. Food and Drug Administration has issued new government standards for the manufacture of vitamins and dietary supplements.

The standards are intended to ensure that dietary supplements "are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled," the FDA said Friday in a release.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The FDA said the agency is trying to prevent inclusion of the wrong ingredients; too much or too little of a dietary ingredient; contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals; as well as improper packaging and labeling.

END

FDA News

FOR IMMEDIATE RELEASE
June 22, 2007

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Michael Herndon 
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FDA Issues Dietary Supplements Final Rule

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit http://www.fda.gov/consumer/updates/dietarysupps062207.html.

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Backgrounder: Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements

 

Overview

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplement manufacturers have the essential responsibility to substantiate the safety of the dietary ingredients used in manufacturing a product. 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. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. FDA accomplishes its responsibilities through monitoring safety literature; dietary supplement adverse event reports; and product information, such as labeling, claims, package inserts, and accompanying literature.

As part of DSHEA, Congress gave the Secretary of Health and Human Services and the FDA by delegation, the express authority to issue regulations establishing current good manufacturing practice requirements (CGMPs) for dietary supplements. The FDA has issued a final rule establishing requirements for the production of dietary supplements.

Specifically this rule:

• Requires certain activities in manufacturing, packaging, labeling and holding of dietary supplements to ensure that a dietary supplement contains what it is labeled to contain and is not contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities.
• Requires certain activities that will ensure the identity, purity, quality, strength, and composition of dietary supplements, which is a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.

History

• 1994 - Dietary Supplement Health and Education Act is passed by Congress.
• 1997 - The FDA issued an advance notice of proposed rulemaking that contained CGMPs submitted by representatives of the dietary supplement industry as well as nine specific questions from FDA. Approximately 100 comments were received
• 1999 - FDA conducted numerous outreach activities to include public meetings to ascertain the best approach to rulemaking for dietary supplements.
• 2003 - The FDA issued a proposed rule to establish CGMPs for dietary supplements and dietary supplement ingredients. There were approximately 400 comments submitted in response to the proposal. The comments came from trade associations, government organizations and officials, health care professionals, consumer groups, manufacturers of dietary supplement and dietary ingredients, and individuals. The dietary supplement CGMP final rule and interim final rule (IFR), issued today are based on the comments received and FDA's expertise.
• 2007 - Today the FDA took action to help Americans get accurately labeled and properly manufactured dietary supplements, through its final rule establishing dietary supplement CGMPs. An IFR has also been issued to allow the manufacturer to petition the FDA for an exemption to the 100 percent testing requirement for the identity of dietary ingredients to be used in dietary supplements. The manufacturer would have to provide data demonstrating that less than 100 percent identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.

Science-Based Consumer Protection

• 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 the past, 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.
• FDA has taken enforcement actions against dietary supplements due to undeclared ingredients, subpotency and contamination. Some examples include:
• 2006 - FDA warned several firms after FDA analysis of dietary supplements found undeclared active ingredients used in prescription drugs for erectile dysfunction and their analogs in several dietary supplement products.
• 2005 - FDA issued a Warning Letter to a firm after FDA analysis of two of the firm's products were found to be significantly subpotent in several components, such as Vitamin A, Folic Acid, and Vitamin C.
• 2004 - FDA issued a Warning Letter to a firm after FDA analysis found the firm's tablets to be underweight, such that the weight of the tablets could not contain the amount of nutrients declared on the label. Also, FDA initiated a seizure action against ginseng because analysis found the product to contain illegal pesticide residues

Fact Sheet: Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts

 

CGMP Final Rule:

• The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
• The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
• The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
• The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
• The requirements include provisions related to:
• the design and construction of physical plants that facilitate maintenance,
• cleaning,
• proper manufacturing operations,
• quality control procedures,
• testing final product or incoming and inprocess materials,
• handling consumer complaints, and
• maintaining records.
• To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final CGMPs is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Interim Final Rule:

• The interim final rule (IFR) establishes a petition process for a manufacturer to apply for exemption from the 100 percent identity testing requirements for dietary ingredients used in manufacturing dietary supplements.
• If a manufacturer is granted an exemption, the manufacturer would still be responsible for ensuring the quality of the final dietary supplement product.
• The manufacturer would have to provide data in its petition demonstrating that less than 100% identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.
• The IFR is effective in June 2008 when the CGMP final rule becomes effective. However, there is a 90-day comment period. Based on the comments received, the IFR may be revised.

Consumer Benefits:

• Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled.
• The rule will give consumers greater confidence that the dietary supplement they use has been manufactured to ensure its identity, purity, strength, and composition.
• The 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.

Manufacturers:

• Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers have an essential responsibility to substantiate the safety of their products and 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.
• The CGMPs will help to ensure manufacturers produce unadulterated and properly labeled dietary supplements.
• Under the CGMP rule, manufacturers are 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, labeling and holding;
• Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
• Establish and use master manufacturing and batch production records;
• Establish procedures for quality control operations;
• Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;
• Keep a written record of each product complaint related to CGMPs; and
• Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.
  

• Examples of product quality problems that the rule will help prevent are:
• dietary supplements that contain ingredients in amounts that are greater than those listed on the label dietary supplements that contain ingredients in amounts that are less than those listed on the label
• wrong ingredient,
• other contaminant (e.g., bacteria, pesticide, glass, lead),
• foreign material in a dietary supplement container,
• improper packaging, and
• mislabeled
  

• The interim final rule allows manufacturers to petition FDA for an exemption from the requirement of 100 percent identity testing of one or more dietary ingredients used in manufacturing the dietary supplement. The manufacturer would provide data to demonstrate that its proposed reduced frequency of identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient. Each petition will be considered on a case by case basis.