US Food Regulations

1. US FOOD CLASSIFICATION AND REGULATIONS
1.1 Food Classification
In the US, food is defined as a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum. (Federal Food, Drug, and Cosmetic Act (FD&C Act), SEC. 201. [21 U.S.C. 321])

1.2 Regulatory Authorities
• FDA regulates both domestic and imported foods, except meat and poultry and processed eggs.
• USDA regulates all the fruits, vegetables, meat, poultry and processed eggs.

1.3 General Recognized As Safe(GRAS)
Under sections 201(s) and 409 of the Act, and the Code of Federal Regulations 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common

• Any substance that is Generally Recognized As Safe (GRAS) for a particular user may be used in food for that purpose without pre-market approval from FDA.
• A GRAS determination must reflect the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.
• Those expert views must be based on “scientific procedures,” supplemented in the case of substances used in food prior to 1958 by experience based on common use in food.
• According to 21 CFR, the term “safe” means that there is reasonable certainty in the minds of competent scientists that a substance is not harmful under intended conditions of use.
There are two ways of getting GRAS status:
• Self-determined GRAS
• FDA notification
Required Documents for GRAS

• Name and all pertinent information concerning such food additive, including, where available, its chemical identity and composition;
• A statement of the conditions of proposed use of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including samples of its proposed labeling;
• All relevant data bearing on the physical or other technical effects such additive is intended to produce, and the quantity of the additive required to produce such effect;
• A description of practicable methods of determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use;
• Full reports of investigations made with respect to the safety of such additive, including full information as to the methods and controls used in conducting such investigations
Safety assessment of food and color additives used in food and to assist petitioners in developing and submitting toxicological safety data.
of a food additive.

This information is for reference only. It has no legal value. Davidia Healthtech LLC declines all responsibility or liability for errors or deficiencies in this document. Authorities in various countries have the right to determine a product’s regulatory status. Laws and the related guidance change constantly. We cannot guarantee regulations referred to in the document remain unchanged. The text should not be taken as an authoritative statement or interpretation of the law, as only the courts have this power. Every effort has been made to ensure these guidance notes are as helpful as possible.
Please email info@davidiaglobal.com for more information。

About US

Since 2013, Davidia provided specialized ingredient to enhance product bioavailability, increase the function of the ingredients and help nutrition absorption for the body. We provide high quality product developed under highly quality control process from research lab to commercial products. We are also able to offer a full package of bioavailability tests (In vitro, ex vivo and in vivo test), technical data (specification, test method, QA/QC data, toxicity evaluation, and science literature), regulatory support (NDI, GRAS, label claim), and custom formulation support.

Contact US

Davidia Global, LLC
3974 Sorrento Valley Blvd #910977, San Diego, CA 92191 USA
Davidia Global, LLC
Tel: +1 858 666 1288 Davidia Global, LLC
Cell:+1 858 610 7316 Davidia Global, LLC
Email: Info@davidiahealthtech.com Davidia Global, LLC
www.davidiahealthtech.com Davidia Healthtech, LLC
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FDA Disclaimer

These statements have not been evaluated by the Food and Drug Administration. Those products are not intended to diagnose, treat, cure, or prevent any disease.

Supplement brands must consider traceability, quality assurance, regulations and the budget when they source ingredients.
Hua Deng | Oct 23, 2017

When a supplement brand is considering working with a contract manufacturer, a critical question is: Will the brand take care of ingredient sourcing or let the contract manufacturer take care of it? Key points to consider before making the decision:

Traceability
Quality assurance
Regulatory awareness
Financial consideration
Availability of specialty ingredients
Regardless of the path, at the end of the day, product owners need to take full responsibility of products; it can’t be left to the contract manufacturer.

Traceability

If ingredients are supplied by the contract manufacturer, the brand needs to conduct a site audit or ingredient supplier evaluation report to approve the suppliers. The manufacturer must inform the brand of supplier changes and provide the documentation of the new supplier. For each batch other than finished product certificate of analysis (CoA), a set of ingredients CoAs would help the traceability of the ingredients.

Quality Assurance

Quality is the key point of ingredient sourcing, especially for botanical ingredients. Sometimes, an ingredient’s CoA doesn’t ensure the quality of the ingredient. Botanical ingredients need documentation for plant identification, including the extract solvent, extract method and plant part used for extraction. Active ingredients must be tested with a validated method. A third-party testing report will help ensure the content of active ingredients.

If possible, ask for bioavailability data. High bioavailability could reduce the ingredient usage while maintaining or enhancing the product final efficiency. Microbial testing is a basic requirement. Storage conditions must be considered for some ingredients.

Pesticide testing needs to be considered if the ingredient source has any possibility of contact with a pesticide during growth, including contaminated soil. Heavy metal should be considered, as well.

Regulatory Awareness

The Food Safety Modernization Act (FSMA) has forced brands to consider ingredient sourcing. Brands need to know FSMA and understand its role when sourcing ingredients, especially the importance of foreign supplier verification.

Financial Consideration

Financial consideration often is the most considerable fact for ingredient sourcing. However, for the same ingredients, the price may differ widely from different suppliers. Price is important, but brands that only consider price may be ignoring quality and regulatory issues. The benefit of the contract manufacturer sourcing ingredients is it can purchase in large quantities for economy of scale. A best practice is letting the buyer work with QC/legal personnel during the ingredient sourcing process to balance the budget with the quality and regulatory requirements.

Specialty Ingredients

Specialty ingredient sourcing is challenging. Products need to be innovative, however, it can be difficult to find innovative ingredients in the current market. The best solution is to work with an ingredient manufacturer with research and development (R&D) resources to customize ingredients. The benefits of using a custom ingredient is the ingredient is specialized for a specific brand, not for its competitors; brands can sign an exclusive agreement with the ingredient supplier so the ingredient isn’t available to other supplement brands.

When brands use a contract manufacturer to create a product, whether the ingredient is sourced by the brand or the contract manufacturer, brands need to ensure the ingredient is traced, quality, meets regulatory requirement and fits the company’s budget.

Hua Deng, Ph.D., is the president and the founder of Davidia Healthtech LLC, a professional service company for food, dietary supplement and cosmetics. Deng holds a doctorate from Lanzhou University in China with a major in analytical chemistry. She has extensive experience of global regulatory affairs in the food, dietary supplement and cosmetic industries.