Unless you are a farmer selling over $500,000 worth of crops, I don't believe this bill creates restrictions on you. I could be wrong. Perhaps you are one of those farmers and you have concerns. If there's a specific thing you won't be able to do, that's information that is worth sharing.
Something to keep in mind: just about every regulation, whether it works out for good or ill, is there because someone was seriously harmed or died. That doesn't mean that the regulation is always 100% good or without its own consequences. But, regulations are added because someone didn't take responsibility, and because the free market cannot bring people back from the dead.
The 1938 Food, Drug, and Cosmetic Act - the law that SB510 amends - was itself created in the wake of deaths and injuries.
In any event, 5 years later, Watkins moved his family to the relatively cloistered city of Bristol to join the Massengill company as head chemist. He was 55. In the summer of 1937, he set out to find a liquid vehicle for sulfonilamide at the company and turned his attention to the glycols. He based this decision on their chemical similarity to glycerine, a commonly used solvent in liquid pharmaceuticals [19]. He soon discovered that he could dissolve as many as 75 grains of sulfanilamide in 1 fluid ounce of clear, odorless diethylene glycol. However, the resultant solution tended to separate on chilling, so he reduced the antibiotic concentration to 40 grains per fluid ounce and quickly settled on the following mass-quantity recipe for a stable product [1]:
Sulfanilamide, 58½ pounds
Elixir flavor, 1 gallon
Raspberry extract, 1 pint
Saccharine, soluble, 1 pound
Amaranth solution, 1-16, 1½ pints [a synethic, bright red, azo dye, which was presumably added to resemble the color of the patented Prontosil]
Caramel, 2 fluid ounces
Diethylene glycol, 60 gallons
Water q. s., 80 gallons
No animal or clinical tests were conducted by Watkins or the company at large to determine the toxicity of the individual ingredients or that of the combination. Any possible effects of diethylene glycol on sulfanilamide were also left to chance. The company's sole process for quality control consisted of checking the elixir for its appearance, flavor, and fragrance. The Acting Chief of FDA's Drug Division, Theodore Klumpp, bluntly described the company's elixir development: "[T]he only criteria of its safety and value as a medicine were that the ingredients were mixed, did not immediately explode, and the color, taste and smell of the product were satisfactory to their so-called control department" [20].
Watkins was evidently unaware that, for several years, the FDA had advised against the use of glycol solvents in foods, on the basis of limited safety data [21]. He was also presumably ignorant of 2 published reports, one in 1931 and one in early 1937, which described the lethality of diethylene glycol in experimental animals [22,23].
diethylene glycol is, of course, antifreeze, and highly poisonous.
Commercial lots from 1 pint to 1 gallon were shipped from Massengill's Bristol and Kansas City plants, as well as from its New York and San Francisco sales branches. In all, 633 shipments were made. The product label (example below) failed to list the product's ingredients, other than sulfanilamide. In addition, a total of 671 physicians' or salesmen's samples were sent from Bristol or Kansas City.* In time with the mass distribution, a promotional brochure for physicians announced, "Our research department has just released an Elixir Sulfanilamide...It is ideal for your patients who can take liquidsbut little else. Also, it is not unpleasant to take, so is suitable for children" [28].
Both commercial and sample lots were distributed nationwide through October 15, 1937the same day that Tulsa physicians telegraphed the AMA to convey their autopsy findings from 5 children who had consumed the elixir.
This was written by a doctor, who had no idea what the inactive ingredients were, and who dispensed it to patients, who died:
"Nobody but Almighty God and I can know what I have been through these past few days. I have been familiar with death in the years since I received my M.D. from Tulane University School of Medicine with the rest of my class of 1911. Covington County has been my home. I have practiced here for years. Any doctor who has practiced more than a quarter of a century has seen his share of death.
"But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony." (Letter by Dr. A.S. Calhoun, October 22, 1937)
FDA: Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident
Over 100 people died before the news got out.
The FDA could only fine Massengill for labeling the product as an elixir when it contained no alcohol. It wasn't against the law to adulterate medicines with poisonous solvents, nor was it the law that all the ingredients had to be on the package.
The chemist who created the raspberry sulfa drops committed suicide.
The public was outraged, and this incident is why the FDA was given the authority to require that companies test drugs before marketing them.
