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Product claims. There are four types of claims, FDA classifies product claims in four categories.
I won't go into details on those right now with; nutrient, relative structure, function
claims, and health claims.
A lot of companies make the mistake of, if they produce, for example, a dietary supplement,
and here it's regulated perhaps, or considered a drug, and you may have certain claims on
your product here in Vietnam: that it cures cancer, or lowers blood pressure, some other
element.
FDA is very strict about health claims. So you need to be careful, because in fact what
you might consider here to be a drug, FDA may also consider it to be a drug, but an
unapproved new drug.
So it would be a drug that FDA would not consider to have been approved, and you're not likely
going to want to go through for the approval process.
Often manufacturers of dietary supplements encounter problems on this claim, on the claim
issues. Now if you know that your label is wrong, you have a problem with your label
you have a new order, let's say it's a first order. Or you've had a problem in the past
and you're worried about your labeling, you are permitted to use stickers to cover up
or to add information onto your label.
So if you have a very small shipment, you feel that your labeling is correct, but you
don't, for example, have the weights in ounces, you only have in grams. You are allowed to
add a sticker that would indicate also the ounces.
Some common misconceptions. Companies often will say,"Oh, I'm approved by FDA. I've been
licensed by FDA." Doesn't exist. FDA does not approve companies. FDA does not approve
products, except for drug related products. For actual prescription drugs there is an
approval process, but for food and beverages and dietary supplements there is no approval.
There are prohibited substances. A lot of times companies will say, "Well, can I use
this ingredient?" "Does FDA allow this ingredient?" There is a list of permitted ingredients called
the GRAS list, and there's also a list of substances that are prohibited.
So if you're not sure if your ingredient is allowed, those domains here are a good resource
to go and search to determine how FDA might view your ingredient.
The use of the Register, the "R", for a trademark. In order to use an R symbol on your products
in the US, your registration, your product will need to be actually registered with the
US patent and trade mark office.
So, in other words, if you are selling your product here in Vietnam right now, you have
the "R" symbol, because maybe you've registered your mark here. And then you're exporting
it to the U.S., but you don't have a U.S. trademark, you need to remove that "R" symbol.
You can instead, replace it with the "TM," or trademark symbol.
That symbol is used for marks that are not yet registered with the USPTO, but it serves
to put the public on notice of the claim of your ownership.
If you are interested in registering a mark, I can tell you it's not a terribly complicated
process. You can do it directly with the US Patent and Trademark Office.
It typically takes about eighteen months and will cost somewhere around $500 in government
fees. If you hire a company to help you, you could expect to pay $2,000 or $3,000 for them
to help you register a trademark.
So if your Exports to the US are growing. If you have a good brand name and you really
do want to try and gain some protection. I would encourage you to register your brand.
Some other common misconceptions: Bar codes are actually not required by FDA. Most companies
use them because their buyers want to have the bar code, they want traceability, they
want to be able to have it for inventory control. You can purchase, and I apologize, I have
the first website out there, gs1.org, that's a good one.
The second one is if you're in Jordan in the Middle East, which is where I was last week.
But, GS1 is where you can purchase bar codes for your products.
Lot numbers, not regulated by FDA. You're not actually required under FDA regulations
to have a lot number. However, your buyer again, is likely going to want a lot number.
And you would be wise to have a lot number on your product in the event that you need
to have a recall in a product.
Expiration dates are actually not required by FDA. Those again are typically customer
driven, and I would encourage you to have expiration dates on your products.
FDA doesn't require them, because their logic is, an expiration date doesn't necessarily
indicate the quality of the product inside.
You could have a product with an expiration date for two years from now, and in a month
it arrives in the US, and it has gone through extreme temperature changes, and the integrity
of the product has been significantly diminished. And a consumer will look and say, "Well, this
is good for another 24 months," but in fact the product is already spoiled.
So FDA doesn't regulate expiration dates, or require them.
Keep in mind that labelling doesn't stop with your label. FDA uses the word "labeling" to
mean all of your marketing material.
They will look at websites. They will actually go on the internet, and look at a company's
website. website and see, for example, if you have a dietary supplement you produce
and they see you're making a claim on your website about the product, they will issue
a warning letter to you saying, "We've reviewed your website, and we feel that the claims
you're making are false, and it's an unapproved new drug, etc. etc.
So labeling is more than just your label. It might be what you're saying about the product
in your brochure. It might be what you're saying on your website. And, of course, what's
actually attached to the the product.
So, with regards to labeling you want to be sure your labels are formatted correctly,
they have the right information, they're truthful obviously. I recommend that you not copy others,
or rely on your importer to help you. Requirements do change very quickly.
Here's an example, and I think we have some perhaps in the brochure. We offer a service
where we will review your labeling, you send us your for artwork, we'll tell you everything
that's wrong with it. We'll give you a report back that explains why it's wrong based on
the code of federal regulation and then we'll send you back actually a corrected file, a
bracket file, of the artwork of a corrected label.