If you’re preparing to manufacture, import, or distribute a product in the U.S., one of the first and most important legal questions you need to answer is:
“Which federal agency regulates my product?”
This question isn’t just academic. The agency that regulates your product will determine what rules you must follow, what documentation you need, and whether your product is even allowed on the market. Mistakes can lead to costly delays, legal penalties, or having your shipments seized at the border.
In this blog post, we’ll help you understand the differences between the FDA, USDA, and FTC, explain what each agency oversees, and give you a practical way to determine who regulates your product before you ship.
What Federal Agency Regulates My Product?
This is one of the most common Google searches we see from entrepreneurs and small business owners entering the U.S. market. And it’s a fair one—regulatory lines can be blurry, especially when your product touches multiple industries like food, wellness, or technology.
Let’s break down the three major agencies you’re most likely to deal with:
When Is the FDA the Right Regulator?
FDA (Food and Drug Administration) oversees products related to health, wellness, and safety. If your product touches the human body—internally or externally—it likely falls under the FDA’s jurisdiction.
Common FDA-regulated products include:
- Food and beverages (excluding most meat and poultry)
- Dietary supplements
- Cosmetics and skincare products
- Medical devices and diagnostic tests
- Drugs and over-the-counter medicines
- Electronic products that emit radiation (like tanning beds or x-ray machines)
Search Phrase Example:
“Does my supplement need FDA approval before selling?”
Key Things to Know:
- Many FDA-regulated products don’t need pre-approval, but they do need to meet labeling, safety, and manufacturing standards.
- Mislabeling or making unapproved health claims can trigger FDA enforcement actions or warning letters.
When Is the USDA in Charge?
USDA (U.S. Department of Agriculture) regulates meat, poultry, egg products, and certain agricultural products. If your product is animal-based or falls within the realm of farming or organic certification, USDA may be the lead agency.
USDA-regulated items include:
- Meat and poultry products
- Egg products (but not whole eggs—those are FDA)
- Organic certification for food and fiber products
- Certain genetically modified crops
Search Phrase Example:
“Is my beef jerky USDA or FDA regulated?”
Key Things to Know:
- Products regulated by USDA must follow inspection and labeling guidelines specific to the meat/poultry industry.
- Even some joint products (e.g., a frozen meal with meat and vegetables) may fall under USDA jurisdiction if meat is the main component.
When Does the FTC Regulate My Product?
FTC (Federal Trade Commission) is concerned with marketing, advertising, and trade practices, regardless of what the product is. If you’re making claims on your website, labels, or social media, the FTC may step in—even if another agency regulates the product itself.
The FTC typically gets involved when:
- You’re making health, safety, or performance claims in your marketing
- You’re advertising products online, on packaging, or in social media
- You’re promoting testimonials or influencer endorsements
- You’re shipping products across state lines with misleading claims
Search Phrase Example:
“Can I say my product cures anxiety on the label?”
Key Things to Know:
- The FTC works closely with the FDA when a claim involves health benefits.
- If you’re marketing a supplement or skincare product and you claim it “heals,” “cures,” or “treats” a condition, you may be flagged by both agencies.
How to Determine Which Agency Regulates My Product
Here’s a quick checklist to help guide you:
- What is your product used for?
Health, wellness, or consumption? Think FDA. - Does it contain meat, poultry, or eggs?
USDA is likely involved. - Are you making marketing claims?
FTC’s standards apply—regardless of the product type. - Is your product imported?
You may also be subject to U.S. Customs and Border Protection (CBP) and need pre-clearance documentation, especially for FDA/USDA items. - Is the product in more than one category?
Some products fall under multiple agencies. For example, a protein bar with beef might be jointly regulated by the FDA and USDA. A supplement advertised online could be regulated by both FDA and FTC.
What Happens If You Ship a Product Without the Right Compliance?
Shipping a product into or within the U.S. without proper regulatory compliance can result in:
- Detained shipments at customs
- Refusal of entry or distribution
- Product recalls
- Civil penalties or litigation
- Brand reputation damage
As a litigation firm, we’ve seen what happens when compliance is overlooked or misunderstood—and we’ve helped many clients resolve these regulatory challenges.
Why You Should Consult a Lawyer Before You Launch or Import
Federal agencies don’t offer case-by-case legal advice, and trying to interpret agency regulations on your own can lead to expensive mistakes. Consulting a business or regulatory attorney can help you:
- Understand which agency (or agencies) applies to your product
- Review your labeling, marketing, and website content
- Avoid missteps that trigger fines, holds, or lawsuits
- Protect your brand before problems arise
At Ayala Law, we assist businesses across industries with legal reviews of product compliance and provide litigation support when regulatory issues escalate. Whether you’re launching your first product or scaling to new markets, we can help you understand the legal landscape and move forward with confidence.
Final Thoughts: Don’t Guess Which Agency Regulates Your Product—Know Before You Ship
In today’s market, regulatory compliance isn’t optional—it’s essential. Whether you’re dealing with food, supplements, cosmetics, or any consumer good, knowing which federal agency governs your product can help you stay ahead of costly legal trouble.
If you need help figuring out your regulatory requirements or facing a dispute with an agency, contact an experienced attorney in Miami at 305-570-2208.
You can also contact trial attorney Eduardo A. Maura at eduardo@ayalalawpa.com.
Schedule a case evaluation online here.
[The opinions in this blog are not intended to be legal advice. You should consult with an attorney about the particulars of your case].
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