Bethany R. Kennedy, Esq.
Of Counsel
In 2005, Bethany graduated summa cum laude from Arizona State University (ASU) with a Bachelor of Arts in Sociology, a minor in Political Science, and a certificate in Ethics. While at ASU, Bethany participated in its Capital Scholars Program, which included interning at the U.S. Department of Transportation’s Federal Highway Administration Office of Transportation Policy in Washington, D.C.
In 2009, she graduated from ASU’s Sandra Day O’Connor College of Law. In addition to her J.D., she graduated with a certificate in Law, Science and Technology, with an emphasis in Genomics and Biotechnology. While a law student, Bethany served as a judicial extern in the Criminal Division of the Maricopa County Superior Court and as a rules extern at the Arizona Department of Health Services, Office of Administrative Counsel and Rules.
Since 2010, Bethany has practiced administrative and Constitutional law, primarily advising clients in the life science industry on regulatory compliance with FDA and FTC laws. Her experience includes, but is not limited to, reviewing labels and labeling of: conventional foods, medical foods, dietary supplements, over-the-counter (OTC) allopathic drugs, OTC homeopathic drugs, and cosmetics. She has advised clients on pathways to market and the requirements associated with each option. Further, she has represented clients before federal agencies in enforcement actions, such as responding on their behalf to Warning Letters and FDA Form 483 (Inspectional Observation).
Bethany is licensed to practice law in Arizona and New York.
REPRESENTATIVE MATTERS
- Provided FDA label reviews for companies distributing conventional foods, dietary supplements, cosmetics, and/or OTC monograph drugs.
- Provided FDA and FTC claims reviews for companies distributing conventional foods, medical foods, dietary supplements, cosmetics, and/or OTC cosmetic drugs.
- Responded to FDA and FTC Warning Letters for companies manufacturing and/or distributing dietary supplements, such as Warning Letters targeting claims.
Education
- Arizona State University, Sandra Day O’Connor College of Law, J.D. (2009)
- Arizona State University, B.A., Sociology (2005)
Bar Admission(s)
- Arizona (2009)
- New York (2022)
PRACTICE AREAS
- FDA-Dietary Supplements
- FDA-OTC
- FDA-Medical Devices
- DMEs
- HTC
- Cellular & Gene Therapy
- Biotech companies