Health and Wellness Logistics for US Importers

Prior notice is the advance notification FDA requires before food and dietary supplement shipments arrive at a US port of entry. It must be submitted electronically through CBP's entry system and confirmed by FDA before the vessel arrives. The filing window opens 15 days before arrival and closes 4 hours before arrival for ocean shipments and 4 hours before arrival for air. A shipment that arrives without confirmed prior notice can be held by FDA for refusal of entry. We file prior notice on every health and wellness shipment as part of the pre-arrival sequence, with confirmation tracked and on file before the vessel reaches US waters.

An FDA import alert is a standing instruction that authorizes FDA field offices to detain shipments from a specific manufacturer, country, or product category without physical examination. Import alerts are issued when FDA has found repeated violations from a source: contamination, labeling fraud, undeclared ingredients, or lack of facility registration. If your supplier is on an import alert, every shipment from that source can be detained at the US port regardless of the quality of the individual shipment. We check your supplier name and facility registration against active import alerts before your first booking and before each new supplier is added to your program. The FDA import alert database is public, but the check has to happen before goods are produced, not after the container arrives.

DSHEA sets the labeling standard for dietary supplements sold in the US. Required elements include a statement of identity identifying the product as a dietary supplement, the net quantity of contents, the supplement facts panel listing serving size, servings per container, and each dietary ingredient with its quantity, the manufacturer or distributor name and address, and directions for use. Structure-function claims (statements about how the supplement affects the body) require a specific disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Non-compliant labeling is grounds for FDA refusal of entry. For supplement programs with multiple SKUs or multiple origin factories, we collect and review label artwork before the production run, not after the goods have shipped.

Yes, for most supplement formats. Dietary supplements manufactured in India classify under HTS Chapter 21 and pay standard MFN duty rates, which are zero or very low for most tablet, capsule, and powder formats. They are not subject to Section 301 tariffs, which apply only to goods of Chinese origin. Chinese-origin supplement components and finished goods typically carry Section 301 additional duties of 7.5 to 25 percent on top of the MFN rate. For brands sourcing contract-manufactured supplements, India offers a meaningful duty cost advantage over China. The tradeoff is lead time: India to US West Coast runs 22 to 26 transit days from Nhava Sheva, versus 14 to 18 days from Shanghai. For programs with long enough planning cycles, the duty savings usually exceed the carrying cost of the additional transit time.

An FDA examination request means FDA wants to inspect the shipment before it clears. There are two types: a documentary examination, where FDA reviews the labeling, prior notice, and supporting documentation without physically opening the goods, and a physical examination, where goods are moved to an examination facility and opened. Physical examinations add 3 to 10 days to the clearance process and generate port examination fees and potentially demurrage if the container is past its free time. The most common triggers are prior notice issues, import alert matches, labeling questions, and random sampling programs. We escalate FDA examination requests immediately so your compliance team can respond to document requests the same day and schedule physical examinations without unnecessary delay.

FDA examination rates are highest for liquid supplements, herbal and botanical products, products with novel or undeclared ingredients, and any supplement from a manufacturer that has previously had FDA violations. Protein powders and pre-workout supplements get elevated scrutiny for undeclared stimulants and controlled substances. Probiotics are examined for contamination and label accuracy on strain identification. Country of origin also affects examination rates: certain source countries for botanicals and herbal extracts have elevated examination rates due to historical contamination findings. We track examination history by supplier and product category across your program so you can identify which SKUs carry the most compliance risk before they become port holds.

Yes. Supplement programs that sell through Walmart, Target, Amazon, GNC, Vitamin Shoppe, or Costco have both FDA compliance requirements and retailer routing guide requirements on the same shipment. The FDA piece covers prior notice, labeling, and clearance. The retailer piece covers packaging specs, GS1-128 labeling, EDI 856 ASN transmission, and DC appointment compliance. We manage both on the same file. The FDA and routing guide requirements are coordinated at origin during the pre-shipment review so the container arrives compliant on both dimensions, not just cleared through customs.

India to US West Coast from Nhava Sheva or Mundra into Los Angeles or Long Beach runs 22 to 26 transit days, plus 5 to 7 days for origin booking and documentation, 2 to 4 days for customs clearance and FDA prior notice confirmation, and 1 to 2 days for drayage and DC delivery. Total door-to-DC planning window is 30 to 40 days under normal conditions. China to US West Coast from Shanghai or Ningbo runs 14 to 18 transit days with a similar planning window of 22 to 32 days total. Air freight from India or China door-to-door runs 5 to 8 days. For supplement programs with hard launch dates or retail floor-set commitments, we build the booking schedule backwards from the DC appointment, accounting for FDA prior notice timing and potential examination delays on the first shipment from a new supplier.