Classification comes first
Most FDA regulatory questions begin with how the agency would classify a product, because drugs, medical devices, foods, dietary supplements, and cosmetics follow very different rules. Classification often turns on the claims made about a product as much as on what it contains, so a wellness product marketed to treat a condition can be treated as an unapproved drug. Devices range from those that need no premarket review to those that need clearance or approval, while many foods and supplements reach the market without premarket approval but must still meet labeling, safety, and manufacturing requirements. Imports face additional review at the border, where shipments can be detained.
After an inspection or a warning
At the end of an inspection, investigators may hand over a list of observations, commonly known as a Form 483. A written response is not mandatory, but one sent within a short window is often considered when the agency decides whether to escalate to a warning letter. Warning letters are made public and expect a prompt, specific response describing corrective actions. Keep complete records of complaints, adverse events, quality procedures, and supplier controls, since inspectors tend to review them first. Labels, websites, and social media posts should be reviewed together, because a claim made anywhere can define how the product is regulated.
Matching the response to the stage
A first review covers the product, its labeling and marketing, and any correspondence from the agency, so that we can identify the regulatory path and the most pressing risk. For products not yet on the market, the conversation centers on classification and what submissions or registrations may be needed. For companies already facing inspection findings, warning letters, or import detentions, it centers on timing and the content of the response. We also look at state requirements, since some states regulate products such as supplements and cosmetics more closely than federal law does.
