Q&A from the Training on the US Dietary Supplements Compliance

How do I know if my products are dietary supplements or just ordinary food?

The Dietary Supplement Health and Education Act (DSHEA) created a new legal category under the “FOOD” umbrella, designated as, Dietary Supplements”.

In DSHEA, according to paragraph 3(a)(ff)(1), the term “dietary supplement” means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

“(A) a vitamin;

“(B) a mineral;

“(C) an herb or other botanical;

“(D) an amino acid;

“(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

“(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

Therefore, according to the definition of dietary supplement, one essential point is ‘supplement the diet’. Is the product intended to be taken as a meal or with a meal? If the answer is that you take a pill with a healthy meal. It’s definitely a dietary supplements.

 

What are types of the dosage form in the US?

Dietary supplements are orally ingested, meaning they enter the body through the mouth. Thus, a dosage form, like a transdermal patch that you put on your skin and absorb through the skin, is a pharmaceutical delivery form. An injection is definitely a pharmaceutical delivery form. In conclusion, the standard rule is that dietary supplements would be anything that can be ingested orally, such as capsules, tablets, powders, liquids, gummies, etc.

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The prebiotic powder is an ordinary food in China. It is a dietary supplement in the US?

In the US, it can fall into both categories, e.g. conventional foods and as a dietary supplement. An example of conventional food is yogurts while an example of a dietary supplement would be enteric-coated capsules that contain probiotics. The difference between the categories is the label claims and if the product is intended to be consumed as a meal.

The yogurt is intended to be consumed as a breakfast meal and the claims on the packaging are virtually nonexistent. Whereas, the dietary supplement capsule is intended to be consumed with a healthy meal and the label can make structure-function claims that break down the strains and quantities (typically, billions of cfus/g).

 

How to ensure that my dietary supplement ingredients can be used? Is there a list of ingredients that can be allowed to be used in the US?

The FDA takes the other approach, instead of saying here is everything that is allowed, they say there are the things that are prohibited. The FDA provides a list of prohibited ingredients and a very long list of thousands of approved ingredients. You can contact us to get these lists.  

 

If a product is made with an old dietary ingredient, which was listed in the “Old dietary ingredient list” by American Herbal Products Association (AHPA), and this product has been widely used in America as a dietary supplement, now if we want to produce and export such product, is it necessary to make a prior notification for it? Does FDA recognize the AHPA list? If prior notification is not needed, does it mean that the product can be directly marketed after facility registration?

FDA does not recognize the AHPA list, but it is a good material to refer to when you intend to check whether your ingredients are allowed to be used in the US or not. If the ingredients of your product are listed on the AHPA and are widely used as dietary supplements in the US, it can be placed on the US market without New Dietary Ingredient Notification (NDIN). But you can also choose to submit NDIN to avoid any regulatory risk.

A compliant entry into the US market mainly includes formula/label review, facility registration with FDA, prior notice, etc.

 

Are there any updates for the regulation of dietary supplements NMN in the US? What is the possible trend?

There are regulatory updates and the FDA’s website would be the very best place to go. To be honest, there are very few changes from the regulatory aspect. They don’t change very often and usually when they do, it’s pretty big news, so very likely you will hear about it.

What functional claims can dietary supplements make on the packaging?

Dietary supplements occupy this space between food and pharmaceuticals. Dietary supplements kind of squeeze in the middle, and as such they are allowed to make what are called structure-function claims. It means drug claims are not allowed, such as cure, prevent or mitigate diseases. However, it is allowed to make claims such as this will help with healthy circulatory function, which promotes good joint health.

 

Are claims for 100% natural allowed?

In the United States, the term ‘natural’ hasn’t been defined yet. They leave it up to the company to defend their natural claims. So if you are comfortable defending it, you can make claims 100% natural.

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Are there any requirements for dietary supplements to be sold on online platforms such as Amazon?

No, there are not. You can distribute dietary supplements through anything that is allowed in China, such as retail outlets, the internet, face-to-face, etc. There are a lot of distribution models that can be followed.

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Are enterprises required to do Food facility registration with FDA when importing dietary supplements to the US?

Absolutely yes. You won’t make it past the port without it. They will stop you and in fact, they would stop you even before you hit the port because if you go to file your prior notice, you have to enter your food facility registration number.

 

Who can be the US agent for a foreign company? any requirements?

Yes, there are some requirements.

If a company intends to be the US agent for a foreign company, it is required to be registered with the United States government. However, there is no certification body or an FDA-approved list for the qualification of these US agents, so foreign companies are recommended to be mindful to choose a reliable one.

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If you have any other questions, please contact: info@zmuni.com

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