U.S. Health Food Registration Regulations

WFOE Registration, Work Permit, Special Industry Permit application according to Houston Regulations, we need to do KYC (Know your client) before engagement with your assignment.

Email: hou4ww@evershinecpa.com

Or contact by phone in the Texas time zone:
The Engaging Manager Ian Lin, a well-English speaker
Tel: +1-510-996-2685

HLF-TW-10
What are the categories of health food in U.S.? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of health food? Website?

Evershine RD：

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes.
Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids.

Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases.
That means supplements should not make claims, such as “reduces pain” or “treats heart disease.”
Claims like these can only legitimately be made for drugs, not dietary supplements.

FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event.
FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

【Website】

https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements

HLF-TW-20
If a foreign company wants to sell health food in U.S., no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests?
What are the required documents and application procedures? Website?

Evershine RD：
No, FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual food importers.

【Website】

https://www.fda.gov/food/food-imports-exports/importing-food-products-united-states

HLF-TW-30
If a foreign company wants to sell health food in U.S., can it assign a U.S.ese company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

It’s not required. FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing.
However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

If you plan to market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.
You must provide the following in the notification:

1. Your name and complete address.
2. The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
3. A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:

• level of the new dietary ingredient in the product; conditions of use of the product stated in the labeling or if no conditions of use are stated, the ordinary conditions of use; and
• history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will be reasonably be expected to be safe.
• Any reference to published materials must be accompanied by reprints or photostatic copies.
  Any material in a foreign language must be accompanied by a translation.

【Website】

https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient

HLF-TW-40
Do foreign companies need to apply for an approval before importing health food sold to U.S.?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Chinese, which other languages ​​are allowed? Website?

Evershine RD：

It’s not required. FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing.
However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

Under provisions of the U.S. law contained in the U.S. Federal Food, Drug and Cosmetic Act, importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. (All imported food is considered to be interstate commerce.)

What label statements are required on the containers and packages of dietary supplements?
Five statements are required:

1) the statement of identity (name of the dietary supplement),
2) the net quantity of contents statement (amount of the dietary supplement),
3) the nutrition labeling,
4) the ingredient list, and
5) the name and place of business of the manufacturer, packer, or distributor.

Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.
Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.”
In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.”
General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient.
Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread such a disease is in the United States.
These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim.
If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim.
The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.

Written submissions are accepted. Information that is required in the submission includes:

1. The name and address of the manufacturer, packer, or distributor of the dietary supplement product;
2. the text of the statement that is being made;
3. the name of the dietary ingredient or supplement that is the subject of the statement;
4. the name of the dietary supplement (including the brand name); and
5. the signature of a responsible individual or the person who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

【Website】

https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements

https://www.fda.gov/food/food-imports-exports/importing-food-products-united-states

https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide

https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-vi-claims#6-37

https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims

https://www.fda.gov/food/information-industry-dietary-supplements/structurefunction-claim-notification-dietary-supplements

HLF-TW-50
Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Chinese, which other languages ​​are allowed? Website?

Evershine RD：

Yes. FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing.
However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

Under provisions of the U.S. law contained in the U.S. Federal Food, Drug and Cosmetic Act, importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements.
(All imported food is considered to be interstate commerce.)

What label statements are required on the containers and packages of dietary supplements?
Five statements are required:

1) the statement of identity (name of the dietary supplement),
2) the net quantity of contents statement (amount of the dietary supplement),
3) the nutrition labeling,
4) the ingredient list, and
5) the name and place of business of the manufacturer, packer, or distributor.

Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.
Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.”

In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.”
General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient.
Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread such a disease is in the United States.

These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim.
If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim.
The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.

Written submissions are accepted. Information that is required in the submission includes:

1. The name and address of the manufacturer, packer, or distributor of the dietary supplement product;
2. the text of the statement that is being made;
3. the name of the dietary ingredient or supplement that is the subject of the statement;
4. the name of the dietary supplement (including the brand name); and
5. the signature of a responsible individual or the person who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

【Website】

https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements

https://www.fda.gov/food/food-imports-exports/importing-food-products-united-states

https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide

https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-vi-claims#6-37

https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims

https://www.fda.gov/food/information-industry-dietary-supplements/structurefunction-claim-notification-dietary-supplements

HLF-TW-60
What are the required documents for the application of importing health food registration?
What is the application process? Website?

Evershine RD：
FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing.
However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

If you plan to market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

You must provide the followings in the notification:

1. Your name and complete address.
2. The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
3. A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:

• level of the new dietary ingredient in the product; conditions of use of the product stated in the labeling or if no conditions of use are stated, the ordinary conditions of use; and
• history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will be reasonably be expected to be safe.
• Any reference to published materials must be accompanied by reprints or photostatic copies.
  Any material in a foreign language must be accompanied by a translation.

【Website】

https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient

HLF-TW-70
What are the laboratory inspection materials that need to be attached for TFDA verification?

Evershine RD：

FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event.
FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

【Website】

https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements

HLF-TW-80
After a foreign subsidiary imports health food and entrusts a distributor in U.S. to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if health food products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

We recommend that all serious adverse event reports received by the responsible person should be reported to FDA within 15 business days of receipt, regardless of the means by which the responsible person received the initial report.

Although the FD&C Act does not expressly require a responsible person to take action in the event that it receives a report of a serious adverse event in which the initial reporter identifies the suspect dietary supplement as one manufactured, packaged, or distributed by another responsible person, we recommend that such reports be promptly forwarded to that other responsible person.

【Website】

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-adverse-event-reporting-and-recordkeeping-dietary

Contact Us

Houston Evershine BPO Service Limited Corp.
E-mail: hou4ww@evershinecpa.com
or
Contact by phone in the Texas time zone:
The Engaging Manager Ian Lin, a well-English speaker
Tel: +1-510-996-2685
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4hou@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
LinkedIn address: Dale Chen

Additional Information

Evershine CPAs Firm Headquarters
6th Floor 378 Chang Chun Rd., Taipei City, Taiwan ROC
Partner Kerry Chen,  USA Graduate School, and a well-English speaker
Tel No.: +886-2-27170515 ext. 105
Mobile: +886-939357000
Email: kerrychen@evershinecpa.com
Skype: oklahomekerry

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Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
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Evershine Potential Serviceable City (2 months preparatory period):
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(version: 2024/07)