FDA Import Requirements and Compliance: Part 4 – Product Labeling and Product Claims



product claims there are four types of claims FDA classifies product claims and four categories I won't go into details on those right now a 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 are considered a drug and you may have certain claims on your product here in Vietnam that it cures cancer or or lowers oil pressure some other element FDA is very strict about health claims so you need to be careful because in fact with you might consider here to be a drug FDA may also consider it to be a drug but an unimproved new drug so it'd be a drug that FDA would not consider to have been approved and you're not likely going to want to go through the approval process often manufacturers of dietary supplements encounter problems on this claim on the claim that shoes now if you know that your label is wrong you have a problem with your label you have an order that's it's a first word or you've had a problem at us 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 announces the only having grams you aren't allowed to add a sticker that would indicate also the ounces some common misconceptions companies often will say oh I'm I'm approved by FDA I have been licensed by FDA doesn't exist FDA does not approve of companies FDA does not improve products except for drug related products ok so 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 grass list and there's also a list of substances that are prohibited so if you're not sure here in reading is allowed those domains here are the resource to go in search to determine how FDA might view your ingredient the use of the register the are for trademark in order to use an art symbol on your products in the u.s. your registration your product will need to be actually registered with the US Patent and Trademark Office so in other words if you are used selling your product here in Vietnam right now you have the our symbol because maybe you've registered your mark here and you're exporting it to the US but you don't have a US trademark you need to remove that our 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 US Patent and Trademark Office it typically takes about 18 months and will cost somewhere around five hundred dollars in government fees if you hire a company to help you you could expect to pay two or three thousand dollars 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 to register your brand some other common misconceptions bar codes are actually not required by FDA mothers comedies use them because their buyers want to have a barcode they want traceability they want to be able to have it for inventory control you can purchase and I apologize i have a 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 barcodes for your products lot of hunters not regulated by the FDA you're not actually required under FDA regulations and 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 about your product in the event that you need to ever recall any product expiration dates are actually not required by FDA those again are typically customer driven and i 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 and the integrity of the product has been significantly diminished and a consumer will Logan say well this is good for another 24 months when in fact the product is already sporting so FDA doesn't regulate expiration dates were required keep in mind that lady Blanc doesn't stop with your label FDA uses the word labeling to me of all of your marketing material they will look at websites they will actually go on the internet and look at a company's 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 it claimed you're making or false and it's an unapproved new drawing etc etc so labeling is more than gesture label it might be what you're saying about the product in your brochure like what you're saying on your website and of course what's actually attached to 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 to change very quickly here's an example I think we have some perhaps the for sure we offer a service where we will review your label and you send this year before artwork will tell you everything that's wrong with it will give you a report back that explains why it's wrong based on the code elation and then we'll send you back actually a corrected file a graphic file the armor of a corrected label

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