Determining the Regulatory Status of Your "Food": Hot Topics in FDA Regulation of Foods, Dietary Supplements, and Medical Food

(600 Ratings)

Produced on: May 19, 2016

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 61 minutes
Difficulty Intermediate

Is it a conventional food? Is it a dietary supplement? Is it a medical food? Or is it a drug? The answer to this question can have significant consequences for a consumer products company marketing an edible product in the United States.

This course, presented by Raqiyyah Pippins, Counsel at Arnold & Porter and trusted advisor of consumer health product companies and organizations, reviews the legal issues that should be considered by any company contemplating the development of a product intended for consumption by humans, that will be marketed with health-benefit claims. Decisions regarding the ingredients, target audience, and product claims for the product can have a significant impact on how the product is regulated by the Food & Drug Administration and non-compliance with the applicable regulations can be very costly to a company.  

Learning Objectives:

I.      Identify the different regulatory classifications that can be given to edible products promoted with health-benefit claims

II.     Grasp relevant federal and state laws and regulatory activity related to the different regulatory categories (conventional food, dietary supplement, medical food and drug)

III.    Obtain practical guidance to assist you with reducing the legal risk of your product obtaining an undesirable regulatory classification from the Food & Drug Administration 

Faculty

Raqiyyah Pippins

Arnold & Porter LLP

Raqiyyah Pippins focuses her practice in the areas of FDA food, dietary supplement, over-the-counter drug and cosmetic regulation, and FTC consumer protection and advertising law. Ms. Pippins represents companies that are engaged in the development, marketing, import and export of food, drugs, cosmetics, and medical devices. She also counsels organizations facing advertising challenges, and defends companies in investigations conducted by the FDA, FTC, and state agencies regarding product marketing practices.

Ms. Pippins has particular experience assisting companies engaged in Rx-to-OTC switches and the development of clinical and sensory studies intended to substantiate advertising claims. She is a trusted advisor of trade organizations supporting manufacturers of FDA-regulated products and is regularly invited to work directly with clients’ marketing and research and development teams to help identify marketing strategies that are consistent with the desired risk threshold for the company.

 

Experience

  • Manufacturers of FDA-regulated products regarding effective product promotion via diverse mediums (e.g., labeling, website, television networks, social media and platforms intended for handheld-devices) while accounting for FDA, FTC, NAD, state regulation and other risk considerations.
  • Manufacturer of market leading OTC allergy products in successful development and implementation of multi-faceted marketing campaigns for product portfolio, including 1st in class Rx-to-OTC switched intranasal corticorsteriod product.
  • One of the largest US drugstore chains in coordinating the review of more than 600 generic brand labels, including an assessment of claim substantiation and compliance with federal labeling regulations.
  • Global Fortune 500 companies and manufacturer of market leading OTC drug products in 15 challenges before the National Advertising Division (NAD) of the Advertising Self-Regulatory Council including challenges related to comparative efficacy claims, preference testing, and deceptive pricing.
  • Consumer packaged goods companies with responses to FTC inquiries regarding advertising practices, including marketing claims for FDA-regulated products sold directly to consumers.

 

Reviews

MB
Matthew B.

Raqiyyah Pippins is an excellent presenter/educator in this area of law!

WS
William S.

Great presenter!

KV
Kenneth v.

Great discussion of an icrededibly complex subject

CM
Carey M.

The presenter was awesome - very thorough and nice to listen to.

GW
Geneace W.

Good CLE.

HW
hilory w.

Very well done, extremely informative.

MN
Mary N.

Excellent seminar. Excellent speaker

DS
Deborah S.

Presenter was very well prepared and knowledgeable

DT
Donna T.

The presentation provided and excellent well informed speaker who was knowledgeable about legal and practical aspects of food industry law.

KP
Katherine P.

Ms Pippins did an excellent job!

AR
Abigail R.

The content was also useful to me as a consumer.

AC
Andrew C.

Great instructor.

JC
John G C.

Excellent Speaker. Excellent Topic.

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$59

$ 59 Health Care Law and Food, Beverage, & Agriculture In Stock

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