Re: Does FDA rules apply question

[Guest guest]

In a message dated 9/4/04 12:41:22 AM !!!First Boot!!!,

discuss@... writes:

For the sake of simplicity, say I sell my soaps only at local craft shows.

Do FDA regulations apply?

Yes - they're Federal regulations.

-

[Guest guest]

Diane your entire question is confusing to me! I'm not the one to

answer....but I'm wondering how anyone could think that federal rules

do not apply across state lines....what's the point in being federal,

eh? Maybe, are you thinking that FDA rules dont' apply to

international import/exports (do they)? Could you clarify your

question or am I just clued? ~

> Someone on another list made the statement that FDA rules don't

apply to

> anything not sold over state lines. Is this true?

> If it is, does it matter if you bought your supplies from out of

state? And

> what if you sell to a customer while you and the customer are in

your state,

> but the customer takes your product out of state with her/him?

> Diane

[Guest guest]

> Someone on another list made the statement that FDA rules don't

> apply to anything not sold over state lines. Is this true?

If a nexus can be established with the instrumentalities of interstate

commerce or the matter is deemed to substantially affect interstate

commercial transactions, the FDA is going to have a claim in the

matter. For example, if a manufacturer sells only in intrastate

commerce, but utilizes interstate components, a nexus may exist and

the firm and its products made subject to the FD & C Act. To complicate

matters, through various agreements, the FDA also assists the states

in regulating products in intrastate commerce.

Moreover, even if the FDA were to have no jurisdiction in the matter,

your state will likely have its own laws governing misbranded

products, e.g. products which may be labeled contrary to consumer

expectations. FDA regulations may even be used by your state to

identify such consumer expectations.

> does it matter if you bought your supplies from out of state?

What you are asking is what constitutes an interstate component, or

what does it take to establish an interstate nexus. My answer would

be that a nexus to interstate commerce is determined by the class of

activities regulated by the statute as a whole, and not by the simple

act for which an individual may be charged. In essence, though your

individual acts may be seemingly local and private in nature, a

general regulatory statute bears a substantial relation to commerce.

Therefore, the de minimis character of individual instances arising

under that statute is of no consequence in determing whether the FDA

has jurisdiction.

> And what if you sell to a customer while you and the customer are in

> your state, but the customer takes your product out of state with

> her/him?

This relates directly to what I just described.

> If it isn't true, can you point me to the where the regs regarding

> this, or better yet an interpretation of them are posted?

Such regulation is permissible under the Commerce Clause of the U.S.

Constitution because the activity as a class is either in or

substantially affects commerce and because regulation of its

intrastate aspects is necessary and proper to effectuate the

regulatory scheme.

[Guest guest]

Diane, looked up nexus in dictionary and it's basically a series of

groups all connected.

Hmm, I'm still feeling confused but then so are you! I think the best

thing to do if you are concerned with not breaking rules (and there

are tons out there-yuck), you check with local, state and government

agencies with questions specific to where you live.

It drives me nuts how some mail order companies in other states charge

me my local tax rate and others don't.

Then there are times I've heard that some states or counties allow

certain ingredients to be sold in bulk, say Everclear (alcohol) which

may be used in perfumery....but then other states or counties won't

allow sales of Everclear in bulk.

How about medical marijuana, I don't think that's federally approved

is it? That's a state-by-state thing, no?

Well, maybe you see my point and I'm seeing yours? And the answers are

in the government section of your phone book plus sitting on hold

forever after....

[Guest guest]

The best thing for me to do is be aware of the federal and my state

regulations.

The statement was made on another list that FDA regs don't apply unless a

product crosses state lines. If that's not true, I'm concerned over how

many people might believe it, and I wanted to respond, but I also wanted to

get my facts straight. There are people on this list who seem to be very

knowledgeable about these things, so I'm asking here.

The term nexus was mentioned because 'cross state lines' can apply to raw

materials, and customers leaving the state after buying your product. I

still don't know how much of an effect those two might have.

Diane

GreenFireHerbs.com

" Never say 'can't' when there's a 'How About This' still to be tried! "

-----Original Message-----

From:

Diane, looked up nexus in dictionary and it's basically a series of

groups all connected.

Hmm, I'm still feeling confused but then so are you!