Federal Food, Drug, and Cosmetic Act

There's been a recent change in the United States regulations, and it's the first big change since 1938.

So the Modernization of Cosmetic Regulation Act, or MOCRA, of 2022 is the first major policy update, like I said, since the 1938 Food, Drug, and Cosmetic Act.

And that act was the one that helped regulate things like arsenic in your pickle relish and things like that, and hopefully eliminate things like that.

The MOCRA requires the following.

Suddenly, the photographs in the Chamber of Horrors were impossible to ignore.

The law finally passed in 1938, the Federal Food, Drug, and Cosmetic Act, the first law in American history giving the government real power over cosmetics.

The power to define a dangerous product as adulterated.

The power to walk into a warehouse and seize it.

And for a REMS modification, the statutory factors are very similar.

It's in 355-1 of the Food, Drug, and Cosmetic Act.

It lists specific statutory factors that FDA has to consider.

And FDA is bound, as an agency, tasked by Congress with doing this, by following the directions that Congress gave it, that Congress set out for how to assess the REMS modification.

But this is why.

Uh, 1938, you have the food- Federal Food, Drug, and Cosmetic Act- Ooh ... of 1938 passed by Congress.

Strengthens the FDA.

Um- Was this because of the Lip Dip? No, I don't think so.

The FLPC warned that displacing those requirements without giving FDA corresponding authority and resources could weaken food safety oversight.

The report also raised concerns about the potential effects on state consumer protection and tort claims because the Federal Food, Drug, and Cosmetic Act does not provide a private right of action.

At the heart of the debate is the appropriate balance between creating a uniform federal system and preserving states' authority to establish their own protections.

The bill's sponsor, Florida Representative Kat Kamek, has argued that a growing patchwork of state regulations increases costs for consumers and fails to provide a uniform national food safety standard, a position that was also supported by industry witnesses during an April congressional hearing.

There are a few things that do kind of set me off.

Audits are one of them because when FDA walks in the door, and it really is, you are doing an inspection under 704A of the Food, Drug, and Cosmetic Act.

So it's just, It's definitions, and I think it's probably just who trained you as you came on.

I still remember the gentleman, one of my great friends from FDA, a gentleman by the name of David Glasgow.

Investigation means for-cause inspection? No, you

know, you get me excited when I start talking about these things.

So, you know, inspections, everybody knows under Section 704 of the Food, Drug, and Cosmetic Act, and BIMO is under Section 704A5 of the Food, Drug, and Cosmetic Act now because we had an A19 circular that went out in 2022 as part of the budget.

But investigations are something completely different under Section 702 of the Food Drug and Cosmetic Act.

Why does America allow chemicals, additives and ingredients that you don't find in European food?

It's because when we passed the Food, Drug and Cosmetic Act in 1948 and started regulating ingredients for the first time, There was a Congress decided, OK, we don't want to regulate.

We don't want to make companies prove the safety of ingredients that have been used for a long time, like vinegar and salt and yeast and those kind of things.

And so if something is generally recognized as safe, grass, generally recognized as safe, Companies don't have to do a safety study.

little bit? Chobani very recently faced a lawsuit that is still ongoing over its use of allulose in yogurt products with a similar sugar-free claim.

The U.S. 7th Circuit Court last month revived a proposed class action case filed against Chobani, and that reversal argued that allulose, although regulated by the FDA and the Federal Food, Drug, and Cosmetic Act, there is backing for arguments that the ingredients should be included under total sugar listings.

That was the claim of the court.

With this now as a source that these lawsuits can cite, brands are apparently now facing a number of class actions, or proposed class actions, rather.

It's from the 119th Congress second session.

And it's basically wanting to amend the Federal Food, Drug, and Cosmetic Act to provide a period of market exclusivity for botanical drugs and for other purposes.

and it's called the Advancing Botanical Drug Development Act of 2026.

And it says, Congress finds the following chronic age-related diseases are among the leading causes of disability, impaired quality of life, and health care spending in the United States.