I agree that transparency is at issue here. FindLaw defines ethics as the "term used to describe a code of conduct governing proper professional behavior, which establishes the nature of obligations owed to individuals and to society." If transparency is an issue, the legal definition of ethics seems to support that consumers should readily know that foods available for consumption have traces of antifreeze in them. If I knew that when I was a young mother, I would have NEVER purchased them for my children.

I agree that transparency is at issue here. FindLaw defines ethics as the "term used to describe a code of conduct governing proper professional behavior, which establishes the nature of obligations owed to individuals and to society." If transparency is an issue, the legal definition of ethics seems to support that consumers should readily know that foods available for consumption have traces of antifreeze in them. If I knew that when I was a young mother, I would have NEVER purchased them for my children.

FDA ethics, and ethics in general, are pretty big concerns. Many people have an issue with the regulation of the FDA, because who regulates them? What are there specific guidelines into regulations, and why are certain things permitted as long as they don't meat a certain criteria?

@dani Great question. To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. The FDA's approval is mandatory medicine must follow the FDA standards regardless of their relevance, efficiency, and appropriateness.

Over the past 25 years, pharmaceutical companies deceivingly promoted opioid use in ways that were not safe or effective contributing to the increase in prescribing, opioid use disorder, and deaths by overdose. Much of the responsibility for the opioid crisis rests with the pharmaceutical industry’s promotion of aggressive opioid prescribing. The fact that opioid manufacturers spread false claims regarding the risks and benefits of opioids is linked to the carelessness of the FDA.

The FDA’s regulatory failures concerning opioids have not gone unnoticed. In 2017, it was determined the opioid crisis was caused in part by “inadequate oversight by the Food and Drug Administration,” for allowing the promotion of opioid use for chronic pain. Despite the criticism, the FDA policies for approving and labeling opioids remain largely unchanged.

What are some ways we can hold the FDA more accountable for the opioid epidemic?

Is the FDA ethical? The FDA ethics may come into question but I am not sure if it is a question of ethics because ethics can be debatable. The FDA is an agency within a branch of government and follows laws passed by Congress and ensures that manufacturers follow these laws. If you feel the FDA is unethical and want different regulations you would need to concentrate on voting in people who will champion the changes you feel would make the FDA more "ethical".

I know that the FDA has to do in-depth research to justify that use of toxic substances in small amounts but at the same time, I read many articles and saw that it wasn't antifreeze but just a component that could be used to create antifreeze. The years of research needed to be done for any product addresses many concerns that the consumer may have and they will even deny a product from going to the market if the risks are too high. The FDA would not be able to allow any products that would be consumed by the public to contain antifreeze since the substance, even in small amounts, can cause extreme illness and even death if ingested. I think that it is ethical of the FDA to approve these products since preservative are used in everything we eat, even fast food. At the same time, there are pesticides that we use to deter bugs from eating crops that are grown in the farms that cause allergic reactions in some consumers. As long as the consumer does not eat excessive quantities of the same product everyday, there should be no dire circumstances created. 

It is not that we consume antifreeze. We consume propylene glycol. Propylene glycol itself is harmless. Manufacturers use this product to produce antifreeze  due to the low melting point, but also they use it a lot in the food industry as a food additive.  According to a public health statement from the Agency for Toxic Substances and Disease Registry Division of Toxicology and Environmental Medicine , propylene glycol is safe to be consumed. It breaks down in the body within 48 hrs. The fact that PG is found as an ingredient in antifreeze raises concerns, but it is also found in paint, cosmetics, beverages and food. As a preservative, it is a low toxicity substance. The FDA is doing the ethical thing. FDA is ensuring the safety of the public health by controlling the manufacturers in using PG in their products.

On the topic of ethical concerns relating to the FDA, there are several points that can be raised. As the original question mentioned, several products on the food market utilize ingredients that have known toxic side effects. The FDA regulates the use of these ingredients and set limits on the quantities allowed, though that does not mean that ingredients are banned. The main ingredient in antifreeze is ethylene glycol, which is not the same as propylene glycol used in candies, confectionaries, and baked goods as a preservative and emulsifier. This is an important distinction to make. Ethylene glycol has been allowed for use by the FDA as an adhesive used in food packaging, which may indirectly become a component of the food, though it has not been approved for addition into the food product itself (citation). However, there are several other products that are approved by the FDA for use that raise health concerns, such as artificial food coloring (Red #40, Yellow #5 & #6), BHA/BHT (synthetic antioxidants), and sodium nitrite and nitrate (preservatives and color fixatives in processed meat). These compounds have been linked to causing cardiovascular health issues and some are considered carcinogenic. Ethically speaking, it is impossible to control the amount of these products that are consumed by the general population, and as such, it would be more ethical to ban the use of these substances altogether and research safer alternatives. 

When objectively looking at the FDA claim, I do not believe this to be unethical. I feel like the same argument can be made about any item meant for consumption, that too much of it is not safe. I do agree that it is extremely difficult to control any consumption, but fundamentally, the FDA's duty is to deem a drug, food, device, etc. safe for public health. The same argument can be made for other foods out there. It can be dangerous to consume too much of any one particular food as your body requires different nutrients. With that being said, I agree with your sentiment because it's as if the FDA is moving backward and not in the correct direction. To remediate this, I think the FDA should have encouraged the companies to identify an alternative solution that can be used instead of antifreeze. This way in the public image, it does not seem as though the FDA is putting a product out there that will harm public health, but rather seems like the FDA is trying to find a better alternative solution.

This topic is very interesting especially when comparing the regulations of the FDA to its counterparts such as the European Medicines Agency (EMA). Antifreeze or propylene glycol is banned in Europe due to its harmful effects consumed in large doses. Although the FDA considers propylene glycol safe in small doses it seems difficult to regulate the amount a consumer is actually consuming. Throughout times the trend seems to be that the FDA has lesser restrictions compared to agencies like EMA and the question becomes why is there so much discrepancies?