Top
US_Flag An official website of the United States government Here's how you know
GOV

The .gov means it's official.

Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

LOCK

The site is secure.

The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

 
U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Fraudulent Products – Hidden Ingredients and Unproven Claims in Products Marketed as Dietary Supplements
February 18, 2022 - December 31, 2024


Activity Coordinators:
Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov)
Description

Products marketed as dietary supplements that contain hidden, harmful ingredients and/or falsely claim to prevent, treat, mitigate, diagnose or cure disease continue to be a public health concern. As the marketplace for dietary supplements has evolved, so has the marketplace for the illegal sale of these adulterated products which contain ingredients ranging from prescription drugs to controlled substances. Furthermore, some companies may prey on vulnerable populations or exploit public health emergencies with unproven claims regarding their dietary supplements. The goal of this presentation is to increase awareness of this public health issue, provide an overview of the steps FDA is taking to protect consumers from fraudulent products marketed as supplements, and provide resources and the means which the public can report issues related to these types of products.

References
  • FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes: https://www.fda.gov/news-events/press-announcements/fda-ftc-warn-10-companies-illegally-selling-dietary-supplements-claiming-treat-diabetes
  • Watch Out for False Promises on Some Dietary Supplements: https://www.fda.gov/consumers/consumer-updates/watch-out-false-promises-some-dietary-supplements
  • Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments: https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments
  • FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-male-enhancement-and-weight-loss-products-sold-through-amazon-ebay
  • Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You: https://www.fda.gov/consumers/consumer-updates/some-imported-dietary-supplements-and-nonprescription-drug-products-may-harm-you
Learning Objectives
  • Define the health hazards associated with fraudulent products
  • Identify the product categories where tainted products are most commonly found
  • Describe one of the regulatory challenges associated with fraudulent products
  • Summarize how fraudulent products or adverse events related to such products are reported
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-020-H04-P, and ACPE Universal Activity Number JA0002895-0000-22-020-H04-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria.Approval is valid until December 31, 2024. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Edwards, Calvin, Chief, Health Fraud Branch, FDA/ORA/OPOP/OSPOP/DE/HFB - nothing to disclose
  • Kornspan, Nicole, Consumer Safety Officer, FDA - nothing to disclose

Planning Committee
  • Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
  • De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
  • Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
February 18, 2022

Expiration Date
December 31, 2024