In the past the FDA has stood as a protector of the american people although sometimes slow to act and often without the full enforcement power of some other government branches.

This may soon change.

The new chair of the FDA Margaret Hamburg has spoken out lately and probably with the Obama administration has been given a bit more rein and ear to the Oval Office than her predecessors have had.

FDA Commissioner Margaret Hamburg, MD, vowed that the agency would be more aggressive in enforcing food and drug safety regulations and quicker to act when a company breaks the law. Read the rest of this entry »

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Well this was a long time in coming and we will have to wait to see the effect but the FDA has set new rules for standards and purity for all of those supplements that we see out there.

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.

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.

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The U.S. Food and Drug Administration (FDA) today will celebrate the centennial of the Pure Food and Drugs Act of 1906 at an event dedicated to the agency’s past, present and future service to the nation.

The ceremony, which will be held at the FDA’s Harvey W. Wiley federal building, will feature U.S. Health and Human Services Secretary Michael O. Leavitt and Acting FDA Commissioner Andrew C. von Eschenbach, M.D. Also in attendance will be senior leaders of the agency, and scores of current and former FDA employees and special guests including former Commissioners of Food and Drugs, representatives of consumer and trade groups, and descendants of Dr. Harvey W. Wiley, the scientist whose early support of food and drug regulations earned him the title of “Father of the Pure Food and Drugs Act.” Dr. Wiley served as the first director of the Bureau of Chemistry of the United States Department of Agriculture, which later became the FDA.

In addition to presentations by Secretary Leavitt and Acting Commissioner Dr. von Eschenbach, the program’s highlights include an overview of the coming public health opportunities and challenges by FDA’s Deputy Commissioners and other senior leaders of the agency. Sean K. Sullivan, Associate Publisher of Good Housekeeping magazine, will speak about Dr. Wiley’s work following government service as Director of the Bureau of Foods, Sanitation and Health for Good Housekeeping magazine.

The modern FDA dates its origin to June 1906, when President Theodore Roosevelt signed the Food and Drugs Act and Congress embarked on a policy of continuous strengthening of public health protections and of their enforcement, first by the Bureau of Chemistry, and later by the FDA. Since then, Americans have benefited from increasingly comprehensive, science-based safeguards for a myriad products essential for health, survival and high quality of life.

Today, these products represent almost 25% of all U.S. consumer spending and include 80% of the national food supply as well as all human drugs, vaccines, blood products, medical devices, tissues for transplantation, radiation-emitting equipment, and animal drugs and feed.

The FDA’s centennial celebration, which include conferences and special forums in cities from coast to coast, have the following aims:

Observe FDA’s role — past, present and future — domestically and internationally in protecting and promoting the health of the public; Inspire future efforts to advance science, innovation, and public health through partnerships and alliances with key FDA stakeholders; Attract new generations of regulatory scientists; and
Salute the contributions of FDA employees, alumni, legislators, academicians, industry, consumer groups, and public health leaders to fulfilling FDA’s mission.

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