FDA and The Sampling of Your Product

The FDA gets its authority to collect samples and conduct investigations from FD&C Act, Section 702(a) [21 U.S.C. 372 (a).  I will try not to use legal statue reference, mostly because I am not a lawyer. Keep in mind that I don’t charge you lawyer fees either and you are getting this advice free. This is about all the legal jargon I am going to reference, but honestly it is difficult to avoid legal jargon, when FDA gets serious about stopping someone from doing something they do not like and seizing your product. Lets talk about the practical side of FDA sampling, why FDA chooses to collect samples and, at times, elects not to collect samples. Let’s start off we a simple but effective snippet of advice. Get paid for your samples, especially if they are expensive. Requesting payment for your product that was sampled has no bearing on the outcome of the case regardless of what you hear. The only exception would be those samples collected per court orders.

Second advice snippet, do not refuse FDA sampling what FDA wants to sample. It really does little good to refuse, and only serves to give encouragement to those investigators and compliance officers that now really want to see your product. They have the tools and ways to figure out how to see it with or without your cooperation. For example they can use a 301(K) sample that are referred to as the “back door” samples. The 301(k) sample is basically the sampling of a product that you take possession physically or legally by your company and did something to it that caused adulteration. The FDA goes to your supplier to collect the product or paperwork on the interstate shipment to your location, before you got your “dirty” hands on the product and caused an adulteration. They also have those nasty undercover sampling. The investigators buy your product over the mail or nice looking “FDAer- not-me guy” posing as an eager customer. They buy the undercover buys outside state lines, to establish the interstate jurisdiction. They basically are looking to establish Jurisdiction, Violation, Interstate Shipment and Responsibility on each case they develop. Since I am on the subject of refusals, the FDA will issue you a Notice of Inspection 482 if you are being stubborn and not letting them sample. The FD-482 will be modified “to collect samples only.” I will dedicate the entire next sentence to the consequences of inspection refusal when the FDA issues you a 482, Notice of Inspection based on my many years of being refused inspection. Don’t refuse inspection period. You will only be complicating your regulatory position, regardless of what those persons charging you 500 dollars an hour tell you.

There are many fancy names the FDA bureaucracy uses for the different types of samples it collects, but in the end, it is a process to establish a “count” in the fancy court papers filed by the FDA that you did something you were not suppose to do to the FDA regulated product. For example, if they collect 3 samples, they could possibly charge you with three times that you did the wrong deed.

Learn about the different types of sampling FDA conducts and the special instructions to investigators at https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123507.pdf  

Those samples the FDA collects at your site can be used as evidence of the product being adulterated, mislabeled, made in a dirty environment and so on.

If you insist on refusing the sampling of your product because some person with a higher fee per hour than me told you that you can "beat the rap", hold on. The FDA will actually go to court to request an Arrest Warrant for your product, yes, you heard me correctly, an arrest warrant, don’t ask to explain this, I will have to charge you 500 dollars for the explanation. The Arrest in REM has something to do with old maritime law and the need to really get their hands on your product not caring if the owner is around. You know, kind of legal government piracy, unless you fight it in federal court later and prove otherwise.

Frankly most seized product just expires in some US Marshall’s Service warehouse and the FDA files paperwork to have it destroyed if not challenged. 

Once the FDA gets your product, they have to handle it like it was their product, (Evidence-Chain-of-Control). In fact, they have to take care of your product to the degree they have to officially seal it to maintain access. When they sample your food- product, they collect a little extra for that reserved portion in case they need a retest etc. Some samples are not officially sealed, as you will see later.

Different kinds of Samples:

Ok, so you have the “Doc” (Documentary) Sample, the cheapest sample for the government to collect, it consists of only paperwork showing the product bouncing around in interstate commerce to established jurisdiction.

The Official sample is of your physical product or stuff with accompanying paperwork showing interstate movement and responsibility of handling. In-Transit sample, the sample the FDA collects at trucking companies who usually have no idea why they are sampling stuff that does not belong to them from their truck. The 301(k) sample, “Back Door” taken at your supplier of raw material etc., anywhere interstate before it becomes your product that they are alleging is bad product.

The Import Sample, the foreign product entering the USA at a port of entry, that most of the time only needs a lower burden of proof on the adulteration charging you with it “appears” to be adulterated, leaving you puzzled by the phrase “appears.”  This is why many of the samples such as produce samples at the ports do not need to be sealed officially as other samples.

The Domestic Import sample is a product FDA fails to sample while in import status, and is sampled later after the US Customs bond period has expired and is identified as a Domestic Import Sample. The product is now bouncing around in domestic interstate commerce and has attracted the attention of FDA.

At times, the FDA feels it needs supporting evidence to the observations they made at your place while conducting an inspection and they need to show that you have bad controls, and a bad environment where you are making it, so they collect Investigational samples. These samples can be actual product or stuff that might affect your product around it when it’s being made such as rodent droppings and other stuff etc.

There are other samples like certification samples, but unless you are making product that needs the FDA certification, you will not see them taking your product to conduct these type work.

In summary, FDA has the option to take some of your product to sample if they feel they need it to prove their point that your product might be bad. They don’t do it just to do it, since it expensive to have your product tested, and they have limited analytical capability. It also does not help their case if they find your product is really not bad product, and the sample turns out negative. There are also other standard programs such as work plans that require them to test product yearly to make sure it is good product bouncing around in interstate commerce. So FDA has to be wise where, when, what and from whom they collect samples to support their cases.

A final snippet of advice is, that when the FDA conducts an investigation of your place and takes the time to collect and document a sample carefully, it is probable that they are preparing a regulatory package to establish jurisdiction, interstate, violation and responsibility to proceed with a not so favorable inspection endorsement. If they do not even bother with collecting a sample, it is usually party time for the firm.