MONICA L. WALLACE

ATTORNEY

P: 330.983.9974

F: 330.983.9981

mwallace@harpstbecker.com

 

ASSISTANT:

JENNA PENROD

P: 330.983.9971

F: 330.983.9981

jpenrod@harpstbecker.com

MONICA L. WALLACE

ATTORNEY

P: 330.983.9974

F: 330.983.9981

mwallace@harpstbecker.com

ASSISTANT:

JENNA PENROD

P: 330.983.9971

F: 330.983.9981

jpenrod@harpstbecker.com

I am a business lawyer who provides proactive legal advice to businesses and their leaders in corporate and business services, commercial transactions, HR/employment practices, and regulatory compliance. I work with businesses in every stage of the lifecycle from start-ups to mature, established companies. I have spent a significant portion of my career working in-house as an attorney and in management roles, and also managing my own law firm. I have corporate and business experience at the management level, so I understand the challenges business owners and managers face each day. Partnering with my clients, I help develop legal strategies that seek to advance their business objectives.

I have extensive experience advising companies across the U.S. and abroad regarding FTC advertising compliance with a special focus on FDA-regulated products, including dietary and nutritional supplements, food and beverages, OTC drugs, and cosmetics. I review and help clients create labeling and marketing materials that comply with FDA and FTC regulations, as well as state consumer protection laws. International clients have sought my assistance with transitioning their food and supplement brands into the U.S. and responding to FDA inquiries at U.S. ports of entry. I also review manufacturing and supply agreements for both manufacturers and purchasers with a focus on compliance with current Good Manufacturing Practices (cGMP). Clients often seek my help to understand FTC guidance related to testimonials and endorsements in the evolving world of online marketing and seek my advice when responding to regulatory inquiries from the FDA, FTC, NAD or local BBB offices. I also help my clients review and analyze clinical studies and other scientific evidence to confirm they have adequate substantiation to support marketing claims, and help them create permissible claims within the FDA’s guidelines for each category of product (OTC monographs, dietary supplement structure-function claims, nutrition content claims, qualified health claims, etc.).

Practice Areas

  • Employment & Human Resource Law
  • FDA Compliance for the Food, Drug and Supplement Industries
  • Corporate Governance & Business Planning
  • Regulatory Compliance

Admissions

  • Ohio
  • U.S. District Court, Northern District of Ohio

Education

  • The University of Akron School of Law, Juris Doctor (2006)
  • The University of Akron, Bachelor of Science (2003)

ASSOCIATIONS, ORGANIZATIONS AND OTHER POSITIONS

  • Ohio State Bar Association, Labor and Employment Section Member
  • Akron Bar Association Member
  • Society for Human Resources Management, National and Stark County Chapter Member
  • Advisory Board Member, University of Akron College of Business, Institute for Leadership Advancement, Co-Chair (2019-2021)
  • Pro Bono Legal Counsel, The Granted Wish Foundation

“Do the best you can in every task, no matter how unimportant it may seem at the time. No one learns more about a problem than the person at the bottom.” —Sandra Day O’Connor