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NPA Revamps GMP Seminars to Address Changing Regulatory Environment

March 1, 2012 By Steven Perez

The Natural Products Association (NPA) has updated the popular Good Manufacturing Practices (GMP) training program, “What You Need to Know: How the FDA GMP Rule for Dietary Supplements Applies to You.” In light of the Food and Drug Administration’s emphasis on GMP inspections, this course is vital for anyone whose job requires an understanding of the GMP rule for dietary supplements. This includes senior management, regulatory affairs staff and QA/QC, production and laboratory personnel. The first opportunity to attend this seminar will be at Expo West on March 8-9 in Anaheim, Calif. Learn more and register at www.NPAinfo.org/GMP.

The newly-revised program now includes:
•Issues identified in recent FDA inspections and warning letters.
•Examples and case studies illustrating real-life GMP issues and scenarios.
•An overview of industry business models and their respective GMP responsibilities.
The updated format brings more emphasis on the application of what is required for GMP compliance. Companies will be able to use this information to meet their GMP requirements.
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ABC Publishes Article Documenting Supplement Regulations

February 29, 2012 By Steven Perez

Dietary supplements are subject to a wide array of federal government regulations in the U.S., according to a new report published by the non-profit American Botanical Council (ABC), Austin, TX. The article notes numerous authorities to regulate dietary supplements that are granted to FDA and FTC, as well as other government agencies.

The article, titled “The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled,” has been published online and will appear in the winter issue of ABC’s quarterly, peer-reviewed journal HerbalGram. It is the second from ABC on this subject; in 2000, ABC published a seminal article titled “Regulation in the Herb Market: The Myth of the ‘Unregulated Industry’” in HerbalGram. It was written by the co-author of the present article, R. William Soller, PhD, an expert on health policy and the use of nonprescription medications for self-care who has a long history in the regulation of both dietary supplements and nonprescription medications.

Now, just more than a decade later, Dr. Soller, Holly J. Bayne, Esq.—a Washington, D.C.-based attorney specializing in food and drug law with a focus on dietary supplements and botanicals—and Christopher Shaheen, a researcher at the University of California – San Francisco (UCSF), have developed a greatly expanded follow-up article to clarify the breadth and depth of regulation of dietary supplements.
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FDA Issues Anti-smuggling Strategy and Draft Guidance on New Dietary Ingredients

July 19, 2011 By Steven Perez

The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA). FDA has issued an anti-smuggling strategy, and issued draft guidance clarifying agency expectations on new dietary ingredients.

The FDA issued an anti-smuggling strategy developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS) that will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.

“The Food Safety Modernization Act requires the agency to build a new food safety system,” said Deputy Commissioner for Foods Michael R. Taylor. “This new system, overall, will better leverage the resources of federal agencies and it will make industry an important partner in safeguarding the health of U.S. consumers.”

FDA Releases New Dietary Ingredient Draft Guidance

July 7, 2011 By Steven Perez

The FDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to help industry prepare NDI notifications.

The draft guidance is laid-out in a Q&A format and explains the definition of an NDI, when an NDI notification is necessary, the procedures for submitting a NDI notification, the types of data and information that FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI, and what should be included in a NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.

Read the article at Natural Products Insider.

FDA Enforcement of cGMPs for Dietary Supplements

June 1, 2011 By Steven Perez

Companies of all sizes are being inspected.

To become compliant with GMP guidelines, passed in 2007, dietary supplement companies need to perform analytical testing of their products. Analytical laboratory analysis falls under the category of “manufacture” as defined by FDA CFR. Therefore, if testing is not performed, the dietary supplement company will be considered non-compliant regardless of the reason for not testing.

This new challenge for production will require substantial new testing in order to maintain compliance. Some dietary supplement companies have already found that outsourcing the testing, though thousands of dollars per year, is a more sensible business strategy than investing millions developing and maintaining their own compliant laboratories. When outsourcing analytical testing to laboratories, the FDA requires the outside lab to be cGMP compliant and FDA inspected.

NPA Revamps GMP Seminars to Address Changing Regulatory Environment

ABC Publishes Article Documenting Supplement Regulations

FDA Issues Anti-smuggling Strategy and Draft Guidance on New Dietary Ingredients

FDA Releases New Dietary Ingredient Draft Guidance

FDA Enforcement of cGMPs for Dietary Supplements

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