Ordering emoxypine

It's not about the compounds' effects themselves. The people at the FDA OCI are not scientists. They do not "care" about things because of pharmacodynamics or anything like that. They care about whether something is legal to sell or not, and they maintain those are illegal to sell to consumers under any circumstance. I was told point blank by an OCI agent that the job of the FDA is not to protect consumers. It's to enforce the law. They think like any law enforcement organization thinks: what is legal and illegal, and what specific statutes are being broken? That's it. If you are breaking the law and violating the statues, you are a criminal, and they will investigate you and possibly charge you at some point. The FDA OCI runs like the FBI. It is nothing like the civil side of the FDA. That's the side everyone publicly sees, which makes people believe that is how the entire FDA thinks and operates. Most people don't even know about the OCI, but they special agents of the law on par with the FBI.

Also, what I didn't know, and what most people in this industry do not know, is that FDA regulated businesses are one of the ones that actually have an exception to established US law that makes them more risky for the owners. Most criminal statues in the United States require something called mens rea, which means "guilty mind" in Latin. That's the concept in our legal system that you have to know that laws were being broken, or should have reasonably known that laws were being broken, to be charged with a crime. This is why law enforcement agents work to gather evidence about criminal intent, because that is required to charge people with crimes. However, there are a couple industries where Congress wrote the laws in such a way to not require mens rea. FDA regulated businesses like ours are one of those. This means that the statues that deal with FDA issues have a component to them called strict liability. Specifically for us, that strict liability is under 21 U.S.C. § 331(a)
of the Federal Food, Drug, and Cosmetic Act (FDCA). This means that owners or executives of FDA regulated businesses are personally responsible for what goes on at their companies, even if they didn't know the conduct was occurring. That's right, people running FDA regulated businesses can be charged with crimes even if they had absolutely no idea that one of their employees was doing something wrong. It's a component of the law that almost nobody in this industry is aware of. I certainly wasn't, and I am usually pretty sophisticated when it comes to legal issues. This means that because I am the owner and founder, I am personally responsible for EVERYTHING that goes on at any of my FDA regulated businesses. It's my responsibility to build the teams and systems in such a way to ensure laws cannot be broken. If they are, even if they were broken without my knowledge or intent, I personally can be prosecuted for criminal charges. This is what ended up happening. I plead guilty to a strict liability misdemeanor under 21 U.S.C. § 331(a), because my companies sold products that the government maintains are illegal to sell under any circumstances. I didn't personally intend to or knowingly break the law. I fully thought we were compliant. However, that doesn't matter under strict liability claims. The liability is strict. It doesn't need my knowledge or intent. This means any owner of an FDA regulated business is playing with fire, and most have absolutely no idea about this concept. When the OCI comes in, they are not looking to just charge the company itself with crimes. They are looking to charge the owners and executives directly.

Now if they can prove mens rea, they are obviously going to go after more than just strict liability claims. They are going to go after felony charges, and then will ban you from ever owning or operating an FDA regulated business for the rest of your life. That is not what happened with us. I plead guilty to a strict liability misdemeanor to put the whole thing to bed, and the government did not allege intent, or push for a felony with me. I genuinely thought as you did, that there was a legal pathway to selling these things as long as you did it the right way. That was my honest position. Because of that, neither myself nor my companies were charged with felonies. Perhaps I was naive and should have known. Perhaps I needed to get better counsel on things. I had a lawyer, but what I didn't understand is that for things like this, you need specialized regulatory attorneys that actually understand this side of the law. You can't just get any attorney and have them give you proper advice. You have to get specialists. I know that now, and have a team of lawyers at Dentons, the largest law firm in the world, as our regulatory attorneys. I also have a team at Buchanan Ingersoll & Rooney, with the former director of the FDA OCI and former lead OCI agents, as our criminal lawyers with experience with the FDA. I had no idea I needed that type of firepower beforehand. It was an expensive lesson. All in all, it cost me $15 million, and basically ruined my life for over 2 years. I was able to resolve it relatively unscathed, though. Their goal is to put people in prison, and that is what I was facing with our case. This shit is no joke, and any vendors still in that side of the industry need to really honestly take what I am saying seriously. Get out while you still have a choice to.