Transporting powder to the United StatesFDA and DOT’s regulatory focus on powder goods

I. FDA’s regulatory focus on powder goods
FDA mainly regulates powders involving food, drugs, cosmetics, medical devices and some industrial chemicals, focusing on safety, labeling and import declaration.

1. Powder classification and FDA jurisdiction

Food/dietary supplement powders (such as protein powder, spices):

Must comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) to ensure no contamination and correct labeling (ingredients, nutritional information, allergen statements).

A Prior Notice must be submitted to the FDA in advance when importing, and sampling inspection may be accepted.

Drug/biological powders (such as antibiotics, vaccine raw materials):

Must meet the Current Goods Manufacturing Practice (cGMP) and obtain FDA approval (NDA/ANDA) or filing.

Cosmetic powders (such as talcum powder, eye shadow):

Prohibited ingredients (such as asbestos) are prohibited, and the label must comply with the Fair Packaging and Labeling Act (FPLA).

Industrial/chemical powders (such as metal powders, nanomaterials):

If they may come into contact with food or the human body, they must comply with the Toxic Substances Control Act (TSCA) or additional FDA review.

2. FDA key compliance requirements

Registration and declaration:

Food facilities must be registered (FDA Food Facility Registration), and some substances must be reported to TSCA.

Labeling and ingredient disclosure:

Ingredients, country of origin, and manufacturer information (such as “Distributed by…”) must be marked.

Import procedures:

Submit FDA import declaration (FDA PN System), which may be detained for inspection (goods on the DWPE list are at a higher risk).

2. DOT’s supervision of the transportation of powder goods

DOT manages transportation safety through the Hazardous Materials Regulations (HMR, 49 CFR Parts 100-185), focusing on the classification, packaging and transportation compliance of hazardous powders.

1. Determine whether the powder is a DOT hazardous material

UN hazard category (according to 49 CFR §172.101):

Flammable solids (such as metal powder, sulfur powder, UN 1325/UN 3175);

Toxic/corrosive powders (such as pesticide powder, UN 2811/UN 3077);

Oxidizing substances (such as peroxides, UN 1479);

Environmentally hazardous substances (such as certain chemical powders, UN 3077).

Exemptions:

Non-hazardous powders (such as food-grade calcium carbonate) are generally not subject to DOT HMR restrictions, but MSDS (SDS) must be provided to prove safety.

2. DOT transportation compliance requirements

Packaging standards:

Use UN certified packaging (such as UN 4G/X) and mark it completely.

Prevent leakage and anti-static (flammable powders need to be grounded).

Labels and documents:

DOT hazardous material labels (such as “Flammable Solid”) are posted on the outer packaging;

UN number, official shipping name and emergency guide number (such as “UN 3077, ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.”) are indicated on the freight bill.

Qualifications of carriers:

Transportation companies must hold DOT hazardous material transportation licenses, and drivers must have HazMat Endorsement.

III. Other regulatory agencies that may be involved

Environmental Protection Agency (EPA):

Regulates the transportation and use of pesticides and toxic substances (such as lead powders) (Federal Insecticide, Fungicide and Rodenticide Act FIFRA).

Occupational Safety and Health Administration (OSHA):

Requires safe handling of powders in the workplace (such as dust explosion prevention measures, 29 CFR 1910.1200).

IV. Recommended operating procedures

Confirm classification:

Determine whether the powder is FDA/DOT regulated through laboratory testing or SDS.

Compliance preparation:

FDA jurisdiction: complete registration, label review, and submit Prior Notice;

DOT jurisdiction: select UN packaging, train personnel, and fill in dangerous goods transportation documents.

Choose a logistics plan:

Air transport: in accordance with IATA DGR; Ocean transport: in accordance with IMDG Code; Land transport: 49 CFR HMR.

Customs clearance and inspection:

Submit FDA import declarations (such as ACE customs declarations) in advance and prepare DOT documents for inspection.

V. Risk of violations

FDA: Detain, destroy goods or include them in the import blacklist (such as unapproved pharmaceutical powders);

DOT: Fines (up to $77,114 per violation, 49 CFR §107.329), criminal liability (such as major leaks).