Many DTC imports need clearance from partner government agencies as well as Customs, covering food, cosmetics, electronics, toys, and more. A PGA hold is not a customs delay. It is a separate agency deciding whether your product may enter at all.
US Customs and Border Protection operates the border, but admissibility for many products belongs to partner government agencies: the Food and Drug Administration for food, drugs, cosmetics, and medical devices, the Consumer Product Safety Commission for consumer goods, the Environmental Protection Agency and others for their domains.
Each agency can require data at entry, review it, and place a hold, request documents or samples, and refuse admission. A disclaim, where the filer states the shipment is not under an agency jurisdiction, is itself a formal statement that must be true and supportable.
Cosmetics and supplements draw FDA scrutiny over ingredients, labeling, and facility registration. Electronics draw questions on radio frequency authorization and safety standards. Toys and children products draw CPSC attention to lead, phthalates, and testing certificates. Even apparel can draw agency interest for flammability and labeling rules.
The risk is rarely the category alone. It is the combination of category, vague entry descriptions, a new importer with no history, and product claims on the brand own site that promise more than the filing admits. Agencies read websites too.
A hold notice identifies the agency and what it wants: documents, labeling evidence, test reports, registration numbers, or physical examination. The clock matters, because storage accrues and some goods have limited time to be brought into compliance, exported, or destroyed under supervision.
Brands that respond with a complete, organized packet usually resolve holds faster than brands that drip documents one at a time. Assign one owner per hold, keep agency registrations and test reports in an entry ready file before goods ship, and never let a warehouse or broker improvise answers on your behalf.
Filing a disclaim to move faster, when the product is in fact regulated, converts a paperwork shortcut into a misrepresentation. The same applies to copied tariff numbers and generic descriptions supplied by a supplier who has never seen the finished retail product or its claims.
Audit your own entry data quarterly against the actual products: ingredients, materials, intended use, and marketing claims. The filing should describe the product you sell, not the product your supplier wishes they shipped. Most agency trouble starts as a gap between those two descriptions.
Map every SKU to the agencies that govern it before the first purchase order, register facilities and products where required, and keep certificates current rather than chasing them during a hold. Choose brokers who file agency data routinely in your categories and can show their hold rates.
Regulated importing rewards boring preparation. Brands that do the agency work once, at catalog level, ship for years with rare interruptions. Brands that do it per crisis pay storage, lose selling seasons, and eventually face the same work under worse conditions.
Keep reading: How do Section 321 and Type 86 entries work for DTC brands?, What does denied party screening check before a DTC brand ships abroad?, and How should a DTC brand choose and brief a customs broker? cover the nearby cases in this series.
A hold placed by a partner government agency, such as FDA or CPSC, on a shipment at entry. Customs runs the border, but the agency decides whether its regulated product is admissible, and it can demand documents, samples, or examination.
Cosmetics, supplements, and food under FDA, toys and children products under CPSC, and electronics with radio or safety requirements. Vague descriptions and strong marketing claims raise the chance of review in any category.
No. A disclaim states the shipment is outside an agency jurisdiction. If the product is actually regulated, the disclaim is a misrepresentation and creates liability beyond the delay it was meant to avoid.
Map each product to its agencies before ordering, keep registrations and test certificates entry ready, use precise descriptions, and audit entry data against the real product and its claims every quarter.