The Ouk-rra-i-nah Story by Warren Metzler Table of Contents
15. Bureaucratic hurdles
Now to describe other aspects of the project process: In December, 2005, immediately after I returned from the Ukraine, I contacted the graphic artist I used, Adam. We met. I gave Adam one bottle of each of the four products, and he proceeded to begin his design process.
Meanwhile, I sent samples of the four types of vodka I wanted to import to the Federal government lab for testing. And about four weeks later I received the results. I received a pre-import letter for the Presidential Standard, which stated I had to place “Vodka with natural flavoring” on the label. Also a pre-import letter for the pepper vodka, which stated I had to place “Pepper Flavored Vodka” on the label. But no pre-import letter for the two buds vodkas. I was informed the Formulation division could find no evidence that birch buds, birch sap and sweet grass were each GRAS. *(I’ll soon describe what a pre-import letter is.)*
Let me here expand on what GRAS is. GRAS is an acronym, which stands for Generally Recognized As Safe. Back in the late 1800’s the Federal government began to regulate food items, initially testing certain foods to ensure they were safe. Then in the early 1900’s, Upton Sinclair wrote a book called The Jungle, which described extensive unsanitary conditions in the then current meat packing industry. There was an extensive reaction in this country, which resulted in Congress passing the Food and Drug Act of 1906, and considerable more government oversight of the packaged food industry was established. The FDA was established in 1927, which later created a separate division to oversee food and drug sales. A few years latter the FDA established a food safety division, and the first specific requirement for a packaged food was established in the late 1940’s (canned tomatoes). Many more such regulations soon followed. By the way, that 1906 act defined all alcoholic beverages as food.
In the 1960’s, at the request of the Nixon administration, the FDA created the concept of GRAS and established a GRAS database which has since been expanded many times. However, a food substance can still be considered GRAS without appearing on that database. This is because any substance is considered GRAS once the majority of reasonable food scientists in the world accept that substance is safe for human consumption; even when that substance is not listed in the FDA GRAS database.
There is an organization called FEMA; “Flavor and Extracts Manufacturer’s Association”. FEMA has a GRAS panel, made up of expert food scientists, and they meet several times a year to approve substances. If they approve a substance, they then publish what they call a Fema-graph, which states that substance is safe and describes the supporting evidence. Any substance that has a Fema-graph is accepted by government agencies as being GRAS, even when that substance is not listed in the FDA GRAS database.
There is a third way to have a substance listed as GRAS. You construct a package that contains articles from reputable scientific journals anywhere in the world, or articles that describe original research, all of which demonstrate a particular substance is safe for human consumption. You then submit that package to the FDA. If they accept your reasoning, they will send you a letter that states, in essence, “we don’t disagree with your reasoning.” Each such letter is accepted by all Federal agencies as validating that substance is GRAS.
Now both the FEMA process and the FDA package-submission process are expensive. The FEMA process could cost close to, if not in excess of, $50,000. And even if there is plenty of scientific literature available, the FDA package submission process can cost close to $20,000. I intend to pursue this latter route for the two buds products in the near future.