FDA Regulation of Food, Drugs, & Cosmetics

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Из курса от партнера University of Illinois at Urbana-Champaign

Corporate & Commercial Law II: Business Forms, Financing & Governmental Regulation

27 оценок

University of Illinois at Urbana-Champaign

Corporate & Commercial Law II: Business Forms, Financing & Governmental Regulation

27 оценок

This course is the second course in a two-part series on corporate and commercial law. In this part, we focus on three main topics: business organizations, business financing, and governmental regulation. In the first module, we discuss the characteristics of a number of the most common forms of business entities, such as corporations and LLCs. Module two is devoted to debtor-creditor relationships, including bank financing, debt financing, secured transactions, and bankruptcy. We wrap up the course with two modules that focus on the most important aspects of governmental regulation, including the process by which administrative agencies make rules, and the regulation of anti-competitive behavior and securities transactions.

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Module 3: Regulation Part I: Foundations, Consumers, and the Environment

In this module, you will learn about administrative agencies and how they regulate many aspects of business. We will talk about how agencies make rules and then how they enforce those rules. Then we will look at a series of important federal agencies and learn about how they operate within the scope of their authority. By the end of this module, you will understand the basics of the administrative rule-making process and know some of the primary regulatory activities of the FTC, CFPB, FDA, and EPA.

FDA Regulation of Food, Drugs, & Cosmetics4:25

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Professor Michael R Fricke
Teaching Assistant Professor
Department of Business Administration

In this lesson we look at the FDA, the Food and Drug Administration,

which is a very powerful federal agency that regulates basically everything that

can go in your body or on your body.

[MUSIC]

Here we are in our continuing series on very important federal administrative

agencies.

And we're going to talk about the FDA, the Food and Drug Administration.

It was actually created in 1927, but the main enabling legislation these days that

gives the FDA power is the Food, Drug, and Cosmetic Act which was enacted in 1938.

Why was the organization created 11 years before its main enabling legislation

is a long story.

But just know that nowadays the Food, Drug,

and Cosmetic Act is the main enabling legislation of the FDA.

And it regulates food safety, drugs and medicinal devices, and cosmetics and

beauty products.

So let's take each one of those in turn.

Food safety, with regards to food safety,

the FDA does a couple of really important things.

First, it prohibits the sale of what we call adulterated foods.

This is any food that contains a foreign, harmful ingredient, or an additive that's

not permitted or not disclosed, or food that is rancid or has otherwise gone bad.

The FDA prohibits all of this kind of stuff.

In addition to this requires food labeling.

Now if you've ever seen a packaged food item, you know that it has this

black rectangle on it, right, and it says nutrition information.

Foods didn't used to be required to display all this information,

in fact it use to be packaged foods didn't have to disclose anything.

And then they just had to disclose their ingredients.

And now they have to disclose their ingredients and

their nutritional information.

So how many calories from each of your macronutrients,

fats, and carbohydrates, and protein, and all that kind of stuff?

The FDA requires that labeling.

Also requires the label of all packaged foods to contain

the contact information for the manufacturer, so

that if you have a problem with it you know who at least made this good.

Moving on to the next big area of regulation that the FDA oversees,

drugs and medicinal devices.

The FDA requires a really, really extensive trial process before it

approves any drugs to be used in consumers in this country.

So many stages of clinical trials.

You gotta start with animal trials, and then you move on to trials in humans,

multiple rounds of this before a drug will be approved for sale on the market.

And even then, the FDA categorizes drugs.

So some drugs are very highly restricted and

can only be obtained with a prescription.

And even among prescription drugs some are even more highly regulated than others.

And then drugs that have been shown be very, very,

very safe can be sold over the counter.

These are things like Tylenol and stuff like that that we know has very,

very few side effects.

The FDA also regulates the advertising of drugs, especially to consumers.

It actually didn't used to be the case that pharmaceutical companies could

advertise drugs directly to consumers at all.

But the FDA, about 20 years ago, lifted that restriction and

allowed advertising directly to consumers.

But placed rules about mandatory disclosures, disclosures of side effects,

all that kind of stuff.

So if you see an ad on TV for a drug,

you always hear some sort of list of potential side effects.

That's because the FDA requires that to accompany any advertisement for

a drug to consumers.

Now the last thing, or the last real important thing,

that the FDA regulates is cosmetics and beauty products.

So when we say cosmetics, we all know what that means, makeup,

stuff like that, but also any kind of beauty product, deodorant, shampoo,

anything you put on your body, lotions, whatever.

Cosmetics and beauty products are required to list their ingredients and

place any notice of harmful ingredients that might be in the product.

And FDA also prohibits the mislabeling or misleading labels or

any adulterated products that fall into this cosmetics and beauty products realm.

[MUSIC]

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