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Hi, Im going to be buying a dietary supplement in bulk

Customer Question

Hi,

I'm going to be buying a dietary supplement in bulk and then re-packaging it into smaller pouches for re-sale. Are there any rules or requirements I need to be aware of?

Regards,
Stephen
Submitted: 1 year ago.
Category: Business Law
Expert:  JBaxLaw replied 1 year ago.
Hello,

I am a professional here to assist you. I appreciate your use of this service.

Are you looking for information about FDA labeling requirements?
Customer: replied 1 year ago.

Well, I just want to make sure there aren't any issues re-packaging the wholesale product from a manufacturing point of you. We are a small business and not a "manufacturer"....

Expert:  JBaxLaw replied 1 year ago.
Does the product meet FDA requirements for sale in the US including labeling?

Do you have a commercial kitchen you will be using?
Customer: replied 1 year ago.

Well, I'm trying to understand the FDA requirements for sale in the US as well and I'm happy to open up another question if you can help.


 


I don't know the definition of a 'commercial kitchen', so I would think its safe to say no...

Expert:  JBaxLaw replied 1 year ago.
In what state is the business located? I should be able to assist you after obtaining this information.
Customer: replied 1 year ago.

The products will be sold under my LLC in Maryland, via an e-commerce site (we will ship around the country).


 

Expert:  JBaxLaw replied 1 year ago.
I apologize for not being clearer. The locality will likely regulate where and how the supplement, a food product, is packaged. I see you will be selling in Maryland, but I need to know where you will actually be repackaging. I appreciate you patience.
Customer: replied 1 year ago.

It will be re-packaged abroad before being imported.... My partner will re-package after receiving it from the supplier, then ship...

Expert:  JBaxLaw replied 1 year ago.
If I understand you correctly, you will not be involved in repacking the product in the US. That means concerns would be with the product and labeling. Is the product being sold for a particular purpose? Are claims being made about the product?
Customer: replied 1 year ago.

Correct, we are purchasing the product abroad, in bulk and then re-packaging it into smaller 'pouches' abroad and then importing it into the US and re-selling it nationwide, in the US.


 


Its bee pollen, a dietary supplement. Its 100% natural and there are no transformations. In terms of claims, we will talk about the potential health benefits on our website, but we won't "claim" it cures anything on the website or on the packaging.

Expert:  JBaxLaw replied 1 year ago.
To be clear, this is not intended for bee raising uses? Pollen importation for bee feed is not permitted under federal law.
Customer: replied 1 year ago.

No, this is a dietary supplement intended for human consumption.

Expert:  JBaxLaw replied 1 year ago.
FDA labeling is complicated and will require some research. Here is an example of what you want to avoid. See this rejected bee pollen import:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076314.htm

and

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=582-3571959-7&DocId=1&LineId=1&SfxId=

As to getting labeling requirements correct to avoid such a problem, here is the FDA labeling guide:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/DietarySupplementlabelingguide/default.htm

Claims such as "100 percent natural" will be scrutinized. Also, if uses other than as a food are even implied then labeling must meet the requirements for a dietary supplement or drug as opposed to a food label. See:

http://entnemdept.ufl.edu/honeybee/PDF's%202011/producing%20pollen.pdf

Making claims or implying benefits on a website is enough to violate regulations in this area. Those claims or implied benefits need not be on the label.

If a company intends to imply health benefits of a product such as this, they should first speak inquire with the FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance, HFD-310,752O Standish Place, Rockville, Maryland 20855. This may save significant time and money if done prior sales and marketing.

I see that no packing is done in this country or in your state. That means an approved facility for handling the product would not be needed. The concerns are with labeling which will require disclosure of contents and some other information you will find in the guide I provided earlier. You can turn to a
firm to create the label. The other major concern are any claims made related to the product.

This is intended to be a dialogue, so please follow-up.

Also, please take a moment to leave a positive rating. I rely on excellent ratings and optional bonuses to provide this information.

Thank you and I will await your follow-up

Customer: replied 1 year ago.

How do all the other suppliers do it without violating regulations (in terms of implying health benefits)?


In terms of packaging, what is the difference if I do it in Maryland vs. abroad where I source the product?

Expert:  JBaxLaw replied 1 year ago.
As to implying health benefits, it may that they have not been caught. Some have been caught and that can result in costly consequences. If the packaging is done in Maryland, then that state's laws and local ordinances pertaining to handling of products for consumption must be followed. For example, a commercial kitchen may be needed for a food product. That requires an expensive facility, permits and inspections. Please let me know if you need any other information.

JBaxLaw, Attorney
Category: Business Law
Satisfied Customers: 11319
Experience: Experienced in business formation and licensing issues
JBaxLaw and 2 other Business Law Specialists are ready to help you
Customer: replied 1 year ago.

To confirm, because we are packaging abroad, prior to importing, we don't have need to do it through an approved facility?


 


Also, outside of the labeling, are there any other FDA requirements that I need to be aware of?


 


Thanks

Expert:  JBaxLaw replied 1 year ago.
As to "approved facility," there would be no requires as to food preparation or packaging. An importer would need to be used. FDA would also address claims you make regarding such a product on websites or elsewhere whether you imply benefits or state benefits explicitly.
Customer: replied 1 year ago.

So my FDA concerns/requirements are in regards to "implied benefits" and "labeling" on the packaging?

Expert:  JBaxLaw replied 1 year ago.
The FDA's governance is broad, but in regards to selling imported dietary supplements the primary focus are safety, labeling and marketing of that product. This page talks about the basic of dietary supplement regulation by the FDA. See:

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193949.htm

Thank you again

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