Certifications

We operate under the authority of the Federal Food & Drug Administration, Texas Department of Health, the United States Department of Transportation, the Environmental Protection Agency, The Department of Homeland Security, the United Nations, and several other government entities. Here are some short descriptions of what this means to you.

The FDA monitors manufacturers of drug products. Drugs are products that claim to change the form or function of tissues or body systems. For example, the claim "relieves pain" indicates that it will either reduce the transmission or reception of the pain signal. Since reception is done in the brain, a product that relieves pain in that way would have to go through extensive clinical trials to validate the safety and efficacy of the product. On the other hand, preventing the pain signal from being sent by the nerve endings in or near the skin may only require a topical cream. Such a product can be generally regarded as safe provided certain rules are followed. The FDA (The Food and Drug Administration) spells these rules out in the Federal Register, Section 21 (CFR21).

The TDH (The Texas Dept. of Health) monitors cosmetics manufacturers within the state as well as international distribution from Texas to countries outside the US. It also makes determinations on which claims qualify as drug claims independent of the FDA. Sometimes these rules don't match up, so we help our clients make sense of it all and create products and labeling that are approved by all the government agencies with jurisdiction.

The DOT (The Department of Transportation) has certified our employees to properly handle, store, and ship hazardous materials including flammables, corrosives, oxidizers, explosives, radioactive materials, and other items. Using the guidelines laid out by the United Nations, the DOT is responsible for the safe movement of materials by land, sea, and air. The DOT outlines the rules that the airlines, trucking companies, and oceangoing cargo vessels operate under.