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FDA compliance for importers & exporters

Bringing food, dietary supplements, cosmetics, medical devices or other FDA-regulated products into the United States (or sending them abroad) comes with registration, labeling and record-keeping rules that catch many importers by surprise. We help you understand what applies, organize the paperwork and keep your records and calendar in order, working with your customs broker and regulatory specialists where needed.

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How we can help

Which rules apply to your product?

Food, dietary supplements, cosmetics, drugs, medical devices and animal food each have different requirements. We map yours.

Facility registration and renewal

Food facilities renew every two years between October 1 and December 31 of even-numbered years (2026 is a renewal year). Medical device establishments renew every year in the same window. We put it on your calendar.

U.S. Agent for foreign facilities

Foreign facilities that export to the U.S. need a U.S. Agent. We coordinate this for you.

Prior Notice of imported food

Imported food needs Prior Notice before arrival, usually filed by your customs broker. We help you set up the information they need.

Foreign Supplier Verification Program (FSVP)

Importers of food must verify that their suppliers meet U.S. safety standards. We help organize the hazard analysis, supplier files and records.

Labeling checklist

Ingredient statements, allergens, nutrition facts, claims and country of origin, reviewed against a practical checklist before you ship.

Importer of record and duties

Importer of record, customs bonds, tariff classification and duties, coordinated with your broker and reflected correctly in your books.

Records and traceability

Records you can produce quickly when asked. The FDA's food traceability rule is currently scheduled to apply from July 20, 2028 for foods on the Food Traceability List.

The accounting side

Landed cost, duties, freight, inventory valuation and sales tax, so your margins are real.

Exporters

Export certificates, product registrations and the paperwork destination countries ask for, coordinated with the right specialists.

How it works

Review your products

We list what you import or export, where it comes from, and which FDA programs apply.

Organize and register

We prepare the checklist, coordinate registrations and renewals, and set up your supplier and product files.

Keep it current

Calendar reminders for renewals, annual reviews of supplier files, and clean books for landed cost and duties.

Good to know. We are CPAs, not attorneys or FDA consultants. We organize your compliance program, calendar and records, and we coordinate with customs brokers, FDA regulatory specialists and attorneys for technical or legal advice.

Common questions

Do I need to register with the FDA to import food?

Facilities that manufacture, process, pack or hold food for U.S. consumption generally must register, with some exemptions. Importers have their own duties, including Prior Notice and often an FSVP. We help you work out which apply.

What is an FSVP?

The Foreign Supplier Verification Program requires many importers of food to verify that their foreign suppliers produce food that meets U.S. safety requirements, and to keep records of that verification.

When does FDA registration have to be renewed?

Food facility registrations must be renewed every two years between October 1 and December 31 of even-numbered years. 2026 is a renewal year. Medical device establishment registrations are renewed each year between October 1 and December 31.

Can you handle customs clearance?

Customs clearance is done by a licensed customs broker. We coordinate with your broker and make sure duties and costs are recorded correctly.

Related services

Bookkeeping, accounting & CFO support

Clean, current books and clear monthly reports, plus controller and CFO-style guidance when you are ready for it.

Learn more →

New business setup & incorporation

Choose the right structure, form your company in any state, and start with the right tax and accounting foundation.

Learn more →

International business setup

Expanding to India, Canada, Thailand, the UAE, Singapore or Hong Kong, or coming to the U.S.? We plan the structure and the U.S. tax side.

Learn more →

Let's talk about your taxes, your business, your plans.

Tell us what you need and we will get back to you quickly. There is no pressure: just a friendly conversation and a clear next step.

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Prem Tax and Accounting Corp
4260 Westbrook Dr, Suite 107
Aurora, IL 60504
Phone number (shown as a picture)Monday to Friday, 9:00 am to 5:00 pm, by appointment. Saturday and Sunday by appointment when needed.

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Did you know?
  • You can put up to $24,500 of your pay into a 401(k), 403(b) or TSP in 2026. At 50 or older you can add $8,000, and at ages 60 to 63 you can add $11,250 (up to $35,750 in all). IRS: 2026 retirement limits →
  • Work for yourself with no employees? A solo 401(k) lets you save $24,500 as the "employee" and add an employer contribution on top, for up to $72,000 in total before catch-up. A SEP-IRA has the same top limit. IRS: One-participant 401(k) plans →
  • A SEP-IRA can be opened and funded as late as your tax filing deadline, including extensions. That makes it one of the best last-minute ways for a self-employed person to lower the tax bill. IRS: SEP plans →
  • You can put $7,500 in an IRA for 2026, or $8,600 if you are 50 or older, and you have until the April 2027 filing deadline to do it. IRS: IRA contribution limits →
  • A SIMPLE IRA is an easy retirement plan for a small business. Employees can defer $17,000 in 2026, $21,000 at 50 or older, and $22,250 at ages 60 to 63. IRS: SIMPLE IRA plans →
  • An HSA is taxed in your favor three times: money goes in tax-free, grows tax-free and comes out tax-free for medical costs. The 2026 limit is $4,400 for self-only and $8,750 for family coverage, plus $1,000 if you are 55 or older. IRS: Publication 969 →
  • A defined benefit or cash balance plan can let a business owner with steady, high income put away far more than a 401(k) allows, especially after 50. The yearly benefit limit for 2026 is $290,000. IRS: Defined benefit plans →
  • New in 2026: if your Social Security wages from the employer that sponsors your 401(k) were over $150,000 in 2025, your catch-up contributions must go in as Roth (after-tax) money. IRS: 2026 retirement limits →
  • If your income is modest, the saver's credit can cut your tax bill by up to $1,000 ($2,000 for a couple) just for saving for retirement. For 2026 it reaches incomes up to $40,250 single and $80,500 joint. IRS: Saver's credit →
  • When you work for yourself you pay both halves of Social Security and Medicare tax: 15.3% on net earnings up to $184,500 in 2026, and 2.9% above that. Half of it is deductible on your return. IRS: Self-employment tax →
  • The qualified business income deduction can take up to 20% off the tax on pass-through business income. The 2025 law made it permanent and added a $400 minimum deduction if you have at least $1,000 of qualified income. IRS: QBI deduction →
  • Estimated taxes are due four times a year: April 15, June 15, September 15 and January 15. Paying 100% of last year's tax (110% if your income was over $150,000) usually protects you from the underpayment penalty. IRS: Estimated taxes →
  • The business mileage rate rose to 76 cents a mile on July 1, 2026 (it was 72.5 cents from January to June). A simple log of dates, miles and purpose is what turns miles into a deduction. IRS: Standard mileage rates →
  • Tips, overtime and car loan interest can now be deducted even if you do not itemize. The tips deduction is up to $25,000, overtime up to $12,500 ($25,000 joint), and car loan interest up to $10,000. IRS: New deductions →
  • Work from home regularly and exclusively for your business? The simplified home office deduction is $5 per square foot, up to 300 square feet, which is up to $1,500. IRS: Home office deduction →
  • If you are self-employed, the health insurance premiums you pay for yourself, your spouse and your dependents may be deductible even if you do not itemize, up to your net profit. IRS: Self-employed health insurance →
  • In 2026 a business can deduct up to $2,560,000 of equipment it buys and uses, in the year of purchase. And 100% bonus depreciation is now permanent for property acquired after January 19, 2025. IRS: Section 179 and bonus depreciation →
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  • Startup costs for a new business: up to $5,000 can be deducted in the first year and the rest over 15 years, so keep every receipt from before opening day. IRS: Publication 535 →
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  • If your foreign bank and financial accounts total more than $10,000 at any time in the year, you generally must file an FBAR. It is due April 15, with an automatic extension to October 15. An honest mistake can still cost more than $16,000 per late report. Foreign accounts and FBAR →
  • Received a large gift or inheritance from abroad? Gifts over $100,000 from a foreign individual in a year generally must be reported on Form 3520, even though they are not taxable. The late-filing penalty starts at 5% a month. IRS: Form 3520 →
  • Form 8938 and the FBAR are not the same thing. They have different thresholds, are filed in different places and some people must file both. Foreign accounts and FBAR →
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  • The 2026 standard deduction is $16,100 for single filers, $32,200 for married filing jointly and $24,150 for heads of household. Age 65 or older? There is an extra deduction, plus the new $6,000 senior deduction. IRS: 2026 inflation adjustments →
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  • On October 1, 2026 Treasury opened a Trump Account for every eligible child under 18. A parent must claim it in the official app before the $1,000 government deposit (for U.S. citizen children born 2025 to 2028) or any gifts can arrive. Our Trump Accounts guide →
  • If you sell a stock at a loss and buy the same or a substantially identical one within 30 days before or after, the loss is generally disallowed for now. IRS: Publication 550 →
  • Every federal income tax return asks whether you received or sold digital assets such as cryptocurrency. Keep records of every transaction. IRS: Digital assets →
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