Practice Areas & Industries: Barnes & Thornburg LLP

Practice/Industry Group Overview

Barnes & Thornburg LLP’s FDA practice helps pharmaceutical, biotech, medical device, diagnostic, food, dietary supplement and cosmetic companies, as well as other healthcare entities throughout the product lifecycle, from concept, development and approval to manufacturing, marketing, ongoing compliance, investigation, enforcement actions and litigation. We advise clients in these industries on the ever-evolving FDA regulations that govern their products and components. Moreover, we have the government experience and industry knowledge necessary to develop innovative strategies to handle the regulatory challenges that these companies face.

Our attorneys regularly assists clients with issues in a number of FDA-related areas, including:

Medical Devices
According to the FD&C Act, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.” Before granting approval to sell new medical devices, scientists at the FDA review the manufacturer’s data from investigational studies to see if the product does what it claims to do and does not present any unreasonable risks to the patient. Our FDA group can assist with classification of devices; pre-market notifications (510(k)s) and pre-market approvals (PMAs); product liability issues for finished device manufacturers and component suppliers; Good Manufacturing Practices/Quality System regulations; and advertising.

Drugs
Therapeutic drug development is accomplished through a complex series of interactions among government regulators, medical professionals and the pharmaceutical industry. Our FDA attorneys can provide the experience and legal skills necessary to successfully and strategically navigate these multi-faceted exchanges. We counsel clients on virtually all aspects of human and animal drug requirements, including labeling; investigational and abbreviated new drug applications for approval of brand-name and generic drugs; over-the-counter drug monograph compliance; GMPs; and advertising.

Foods
All food products must be labeled in a manner that complies with the laws established by the FD&C Act, the FPLA and the NLEA. Attorneys in our FDA group can assist clients with matters related to labeling (i.e. health and nutrient content claims, allergens, Nutrition Facts); ingredients (i.e. generally recognized as safe (GRAS) self-affirmations, food additive petitions, new dietary ingredients); Bioterrorism Act compliance; GMPs; inspections (international, federal, state and local); import/export; recalls; product liability; and advertising (i.e. weight management, children, competitive).

Dietary Supplements
The DSHEA of 1994 classifies a dietary supplement as “a product taken by the mouth that contains a ‘dietary ingredient’ intended to supplement the diet.” These products are considered a subsection under the general category of “foods” and must be clearly labeled as such. In addition, the organizations responsible for the product are also liable for determining the safety of the supplements, as well as substantiating any representations or claims made about their products with competent and reliable scientific evidence.

Our FDA attorneys assist clients with dietary supplement-related issues including labeling (i.e. health and nutrient content claims, allergens, Supplement Facts, analysis of scientific substantiation); ingredients (including new dietary ingredient submissions); Bioterrorism Act compliance; GMPs; inspections (international, federal, state and local); import/export; recalls; product liability; advertising (i.e. weight management, children, competitive); and adverse event reporting.

Cosmetics
The regulations established by the FD&C Act and the FPLA are among the most important laws pertaining to cosmetics marketed in the U.S. Together, these laws establish the criteria for misbranded products, prohibit the marketing of adulterated or misbranded cosmetics in interstate commerce and require an ingredient declaration so that consumers are able to make informed purchasing decisions. Moreover, the laws hold cosmetic firms responsible for substantiating the safety of their products and ingredients before introducing them to the market. We are available to counsel and assist clients with cosmetic-related issues such as labeling; ingredients; classification of combination products; GMPs; product liability; safety and efficacy testing of cosmetic ingredients; import/export; product recalls; and advertising (including endorsements and testimonials).