Federal Food, Drug, and Cosmetic Act, Essay Example

The Federal Food, Drug and Cosmetic Act was passed by Congress in 1938 after a catastrophe in 1937. A company from Tennessee marketed a new pediatric drug, Elixir Sulfanilamide.  This was supposed to be a phenomenon drug.  Unfortunately, this drug had a component with a chemical signature similar to antifreeze and was fatal in over 100 instances. This caused such an uproar by the people that the Federal Food, Drug and Cosmetics Act was initiated to ensure such a tragedy didn’t occur again. The bill was signed into law by President Franklin D. Roosevelt on June 25, 1938.  The U. S. Food and Drug Administration (FDA, 2012) enforces this act, and it requires manufacturers to prove a product is safe before the drug can be released for sale.

However, the Food Additives Amendment of 1958 had an impact too. It recognized that some additives which had a long and uneventful history would not need to be evaluated for safety (FDA’s Approach to the GRAS Provision: A History of Processes, 2006).

One responsibility specified by the Federal Food, Drug and Cosmetics Act is concerning veterinary medicine.  Animal food and pharmaceutical drugs are regulated by this act. The law required additional provisions for new drugs in 1962 (Regulating Cosmetics, Devices, and Veterinary Medicine After 1938, 2014) and added more limitations in animals as well as humans. The Food Additives Amendment of 1958 restricted the use of drugs used as additives in animal food as well as ensuring the safety of the drugs themselves.

Section 512 of this act requires that any new animal drug for any use or planned use must be considered unsafe unless an approved application is on file indicating use or proposed use of the drug, and the labeling must be current and follow the approved application specifications (Federal Food, Drug, and Cosmetic Act, n.d.).  Another option includes a provisional approval of an application filed indicating the drug use and its’ labeling, and the process must follow the provisionally approved application. An index listing indicating usage or planned use of such drug in a minor species, the drug, its’ labeling and use must adhere to the application.

One of the requirements, when a manufacturer wishes to market a new drug for animals, is an application to the FDA for a NADA (New Animal Drug Applications, 2015), which is an approved new animal drug application.  Alternatively, the business may apply for an ANADA or a CNADA. These acronyms represent an abbreviated or a conditional approval. Under section 512(j) of the Federal Food, Drug, and Cosmetic Act, a new animal drug that is being examined by experts may be shipped interstate even though it has not been approved yet.  These experts should have scientific training, and they should have the ability to determine the drug will cause no harm and to ascertain the efficacy of the drug.

A drug for animals will be considered unsafe if it is removed from the manufacturer’s business for use in animal feed in any state unless the manufacturer, packer or distributor has a valid written statement from the entrusted owner of such statement. If the product is being shipped to the owner of an approved license, the procedure is valid.  Exemptions under the veterinarian-client-patient relationship can be made depending on the situation.  This law makes sure that manufacturers comply with regulations and prove their product is safe.  The FDA establishes a safe level of residue from the drug and decides if there is a risk to public health.

This act requires the manufacturer to be licensed to utilize a specific drug in animal food and requires up-to-date labeling (§360b. New animal drugs, 2010).  Diethylstilbestrol was an example of an added hormone used to stimulate growth in animals and to prevent miscarriages in women. In 1971, the FDA issued a notice advising doctors to stop prescribing this hormone due to a link with a rare vaginal cancer in daughters of women who took the drug. Diethylstilbestrol was banned in the U. S. in 1973 due to the risk of residues in meat (Velle, n.d.).  The law required levels of drugs and hormones that were used in animal food to be restricted to safe levels as indicated by FDA regulations.

One example of an instance where animal food was tainted was in March 2007 when the FDA learned that some pet foods were making dogs and cats sick and in some cases killing them.  Vegetable proteins that were imported from China and that were used in the manufacture of some dog and cat foods as well as farm animal food were found to contain contaminates such as melamine.  After an investigation by the FDA and USDA, two Chinese businesses and one U.S. business and relevant officers were indicted for importing products that were supposed to be wheat gluten but contained melamine (Melamine Pet Food Recall of 2007, 2014).

The FDA has listings of recalled animal foods and drugs on its website.  One example of such a recall occurred on December 3, 2014 and referred to a horse food from a manufacturer, Lakeland Animal Nutrition, in Lakeland, Florida.  Those foods could contain monessen and lasalocid  (Recall — Firm Press Release, 2014).  These substances can kill or seriously injure horses that eat food containing these additives.  The recall was initiated due to death in three horses being fed this product and to extreme reactions in others.

In July, 2010, the FDA shut down an Israeli company, Teva Animal Health Inc. due to dangerous side effects from two injectable drugs that were manufactured there  (Keith, 2010). Butophanol, which is used for surgery, and ketamine, which is an anesthetic, were frequently utilized in veterinary medicine.  Due to five cats dying from use of these drugs, the FDA issued a recall in September of 2010, but the public recall notice wasn’t issued until late December of that year.  In the interim, most veterinarians and pet owners were unaware of the recall.

Another example of contaminated pet food is current.  DuMor sheep formula, manufactured by Purina, can contain excessive levels of copper. This product was sent to seven Tractor Supply stores in Florida. Copper poisoning (DuMOR recall: Purina recalls sheep food in Florida, 2015) can cause such symptoms as anemia, thirst, decreased appetite, red or purple urine and can lead to death within a short time.

Not only does the FDA require safety in drugs and food additives for animals, but they also regulate pathogens such as Salmonella that can be found in food and treats for animals.  In a recall dated May 15, 2015, the FDA targeted OC Raw Dog of Rancho Margarita, CA (OC Raw Dog Recalls Turkey & Produce Raw Frozen Canine Formulation Because of Possible Salmonella Health Risk, 2015) for having their raw canine formulation suspect for Salmonella pollution.

Salmonella can cause such symptoms in people such as cramping and diarrhea, or it can cause more serious problems like endocarditis and arthritis as well as a host of other issues.  Because humans are handling this product, there is danger to the individual as well as the animal.

Pets can present a variety of effects such as diarrhea, stomach pain and vomiting.  Even those animals infected but not showing any signs of distress can infect other animals or humans. More severe cases of Salmonella infection can cause symptoms such as fever, anorexia, weight loss and abnormally fast heartbeat (Salmonella Infection in Dogs, 2015).

Another recall reported in The Seattle Times (Raw, frozen pet food recalled over possible Listeria contamination, 2015) in January concerned J. J. Fudds’ beef and duck raw food for possible Listeria contamination. Listeria can cause dangerous and possibly fatal infections in the young, elderly or those with a compromised immune system. According to the FDA, healthy adults may exhibit such symptoms as extreme fever and nausea as well as other symptoms. A pregnant woman could have a miscarriage or lose a child to stillbirth due to a Listeria infection.  Animals will exhibit similar symptoms to humans.

Something that may not be considered as toxic is salt.  On May 1, 2015, the FDA issued a recall of Blue Seal Home Fresh Starter Amp Medicated Poultry Feed produced by Kent Nutrition Group and manufactured in Columbus, Nebraska (Kent Nutrition Group, Inc. Initiates Recall of Poultry Feed, 2015). This recall involves one lot and is being recalled due to excess salt in the feed.

While salt is a vital ingredient for animals, too much can be toxic and produce such symptoms as trouble breathing, thirst and loss of strength in the legs.  Excessive salt in an animal can also end in death.

One of the concerns that the FDA addresses with provisions in The Federal Food, Drug and Cosmetic Act is the use of antibiotics in animal food and the repercussions of utilizing antibiotics to speed up the weight gain for animals and to prevent disease.  Unfortunately, the indiscriminate use of antibiotics in the production of meat for consumption, has caused or contributed to the development of antimicrobial resistance.  This results in these drugs, when used in humans, to be less effective or not effective at all.  These can result in death or the use of more drugs in an attempt to save an individual’s life.  Governments realize antimicrobial resistance is a public health risk.

The FDA is instigating a voluntary program with the producers of animal food and drugs to remove certain antibiotics from their product (Phasing Out Certain Antibiotic Use in Farm Animals, 2015).  Antibiotics are usually added to the food of animals or in some cases, or they may be added to their water.  It is important that these antibiotics only be used when medically necessary and not used to increase food production when doing so produces a health risk to the world’s population.

The FDA has provided a document in December, 2013 for animal pharmaceutical manufacturers so they will be able to work with the agency to voluntarily eliminate specified drugs.  These drugs are currently used for increased production.  They need to be used for therapeutic purposes under the control of a veterinarian.  This would mean that many of these drugs that are now over-the-counter will only be available through a licensed veterinarian.

In all of these ways, the Federal Food, Drug and Cosmetic Act affects our lives and our health and that of our animals.  Specifically, section 512 in regard to animal drugs, food additives and any adulteration or contamination of animal food is addressed through recalls, directives and requirements for the manufacturer of new animal drugs to prove their safety.

By preventing unsafe drugs, hormones, pathogens to be present in animals, it protects the animals and also the humans who consume the meat of farm animals. Common substances such as salt and copper need to be present in safe amounts.

References

360b. New animal drugs. (2010). Retrieved from 21 U.S.C. : http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360b.htm

DuMOR recall: Purina recalls sheep food in Florida. (2015, February 24). Retrieved from WPTV West Palm Beach: http://www.wptv.com/money/consumer/dumor-recall-purina-recalls-sheep-food-in-florida

FDA. (2012, September 24). The 1938 Food, Drug, and Cosmetic Act. Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/aboutFDA/WhatWeDo/History/origin/ucm054826.htm

FDA’s Approach to the GRAS Provision: A History of Processes. (2006, April). Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm094040.htm

Federal Food, Drug, and Cosmetic Act. (N. D.). Retrieved from U. S. Food and Drug Administration: http://www.fws.gov/fisheries/aadap/CVM%20guidance/Acts%20and%20Laws/FD&C%20Act%20Chapter%20V%20Section%20512.htm

Keith, C. (2010, January 13). Major veterinary drug recall gets bigger / Animal anesthetic drug pulled off market, but questions remain. Retrieved from SFGate: http://www.sfgate.com/pets/yourwholepet/article/Major-veterinary-drug-recall-gets-bigger-Animal-2483151.php

Kent Nutrition Group, Inc. Initiates Recall of Poultry Feed. (2015, May 1). Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/Safety/Recalls/ucm445435.htm

Melamine Pet Food Recall of 2007. (2014, July 14). Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/ucm129575.htm

New Animal Drug Applications. (2015, 1 7). Retrieved from U. S. Food and Drug Adminstration: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDrugApplications/default.htm

OC Raw Dog Recalls Turkey & Produce Raw Frozen Canine Formulation Because of Possible Salmonella Health Risk. (2015, May 15). Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/Safety/Recalls/ucm447095.htm

Phasing Out Certain Antibiotic Use in Farm Animals. (2015, February 25). Retrieved from U. S. Food and Drug Adminstration: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378100.htm

Raw, frozen pet food recalled over possible Listeria contamination. (2015, January 29). Retrieved from Raw, frozen pet food recalled over possible Listeria contamination: http://www.seattletimes.com/life/pets/raw-frozen-pet-food-recalled-over-possible-listeria-contamination/

Recall — Firm Press Release. (2014, December 4). Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/Safety/Recalls/ucm425713.htm

Regulating Cosmetics, Devices, and Veterinary Medicine After 1938. (2014, December 16). Retrieved from U. S. Food and Drug Administration: http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm055137.htm

Salmonella Infection in Dogs. (2015). Retrieved from Pet MD: http://www.petmd.com/dog/conditions/digestive/c_dg_salmonellosis

Velle, W. (N.D.). The Use of Hormones in Animal Production. Retrieved from FAO Coporate Document Repository: http://www.fao.org/docrep/004/x6533e/x6533e01.htm