The purpose of labels on products, whether toys, food, devices, prescriptions, or any other product, is to establish how the product should be used for the individual's safety using it. In this case, if the labels are coming off, even if the product itself is safe, the item should be recalled. My reasoning for the product being recalled is that the product label is no longer on the product; thus, it can not inform the purchaser how to use it safely. Toys for specific age groups no longer have labels that can be choking hazards and cause deaths if parents are not sure due to a label falling off so easily. Maybe a product is not harmful, but when mixed with another product, it becomes dangerous. If they are not informed as the label is missing, it creates another hazard. This would be the same logic for prescription medication. As someone who has a parent that relies heavily on prescription labels daily, it could be hazardous. So I believe the product should be recalled and labels redesigned or a different adhesive used to secure the labels.
The severity of the recall depends on the company. In our everyday life, we can see where some companies chose to only send verification letters of the situation that lead to the recall, and they "suggest" that the consumer follow the guidance of the recall and at other times, due to the hazardous implications with us there is a mandatory recall and sometimes public campaign to comply. When devices are recalled that would mean that they would need to cycle back to the planning stage of the PDCA cycle for accuracy and effectiveness. An example of a recall could be insulin monitoring devices. There are several on the market, however, one can imagine that the devices that are currently being used by the public had to go through several stages and due to the complexity of the function may have had to cycle back through to the planning stage at least once. Putting my example into context with the peeling of the label due to the context of this thread, I would consider the whole product faulty. The label is assumed to carry the necessary information regarding the safety and uses of the product so the company should recall the product and develop a more successful strategy.
If safety information on a label is coming off of the product, there is absolutely a need to recall if the fault is the initial adhesive applied by the company. Information that addresses the safe use of a product is essential to its proper use and should be easily displayed for the customer to see. If the label comes off or is unreadable and an accident occurs due to lack of proper instruction, there could be a lawsuit from the customs and jeopardy of the reputation of the company. There are also FDA regulations that specifically address a medical label's contents, including the side effects and proper use of certain drugs or medical devices. Any violation of these labels calls for a "ding" on the report of the application sent in by the company. Mishandling or misapplication of this label could cause several legal issues down the line.
I agree with those who feel that there should be a recall on the product is the labeling is not correct. I think that label is one of the most important part of the packaging when it comes to a product and although, it is often the last thing that people read, it has the most important information. Just imagine have medicines that had labeling on the package when it left the warehouse but due to the humidity during travel, the labeling is erase due to temperature. Would you but the product without knowing the possible adverse reactions? Would you buy precook packages meal without knowing what is in the ingredients?
In the aspect of the labeling issue, I believe that the company may need to both recall the items and work on improving the production methods. Many devices need warnings or instructions on how to use them. Labels also ensure that the company has their end covered if there is a potential for any lawsuits coming from misuse of a product. So the safest option for the company is to recall the falling labels and ensure that it does not happen again in future products.
Common reasons for safety recalls by the FDA are due to contamination, product/manufacturing defects, or misbranding. In terms of the label itself, the FDA has a standardized set of information that is required to be on the label, such as ingredients, weight, allergy information, nutrition, dates of packaging and consumption, etc. If there is missing information from these standards, then a product safety recall is absolutely required. Of course, there are different labeling requirements for different types of food products, and some vary from state to state. If the label itself on the product is peeling or the adhesives used are not strong enough to keep the label on, then a manufacturing recall may be made to ensure that all products contain a label, though I do not believe this would fall under a safety recall. If the FDA initiates a recall, they may send a warning letter or public notification regarding the matter. However, 90% of manufacturers would likely do a voluntary recall versus the FDA sending them a notification or seizing their manufacturing plants.
Although the labels on products are important I don't think this would cause any recalls. During the peak of covid-19 the FDA allowed manufactures to add or remove ingredients to our products without having to update the ingredient labels due to the constant shortages. Ingredient labels have several loopholes that could possibly have a consumer consume something they aren't aware of. Since this is already occurring I doubt anyone would bat an eye about a missing label is possibly incorrect anyway.
A recall would need to be submitted for issues involving missing information or label errors as it could potentially impact the customer negatively. For example, consider if a pharmaceutical drug has an ingredient that is not listed on the label that the customer is allergic to. The allergic reaction would cause for major issues with the medication, the manufacturer, and the FDA. Therefore, the FDA would have to recall anything that is not properly labeled in order to ensure that customers are fully aware of the device or medication that they are using in order to maintain safety. Additionally, the company producing the device or medication would want to ensure that everything is properly labeled in order to avoid lawsuits and the shutting down of the company, as well as maintain its reputation for producing safe products. In the case of the label peeling off, it should still require a recall to ensure that all of the information is available for the customer. If the label is peeling off so frequently, it may require an improvement in the way that the product is produced and labeled.
I think that the company would still need recall and notify the FDA for the products already out in the market. Labeling is a huge component of a product, and should never be an after-thought. Projects should spend time designing, verifying, and validating the labeling of the product and evaluating how that label interact with the product, the packaging, and the user. Like many other contributors to this question, I think labeling issues such as this can easily lead to very dangerous outcomes. Another situation that I didn’t see mentioned is one that I’ve dealt with in my personal life many times. Being a family member of someone with food allergies has exposed me to EpiPens and how they function/work. Labeling on those devices is crucial to the success of the product. Especially in a scenario where someone is going into anaphylactic shock, and they can’t administer the EpiPen themselves. If they aren’t with someone who knows how to use the EpiPen then it is imperative that the instructions on the pen are clear and available for the user. It could potentially kill someone if the labeling is falling off this device and the user administers the medication wrong. Therefore, I think it is imperative a company recall the products and inform the FDA if there are detrimental issues to the labeling (i.e. labels falling off).
The information presented on the label should be accurate. If there is any mislabeled information we should do a safety recall. Because that could compromise the safety of the public. However, if the label itself is peeling off, and the information is still there and is correct then the company should improve the labels that represent them. In that case, they should invest more money in getting better labels that could last longer so that way customer complaints can be alleviated. Safety recalls should be filed only when the product itself is affecting the public or the audience that is intended to. For example, last year Nestle Purina PetCare Company filed a recall voluntarily because the information presented was mislabeled. Pet owners complain about the texture of the product which was chunky rather than being a pate. Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food in 13.4 oz cans was on the market. The product is ok to give to a dog but the formula was not the right one, and it was intended for dogs requiring a prescription PPVD EN low-fat diet. Purina immediately took it off the market and started working on a replacement.
Although warranted I don't believe the peeling of labels would lead to a recall. If there were to be a recall it would probably be a voluntary recall as it is the manufacturers duty to protect the health of the public. On the FDA.gov website the action of relabeling falls under corrections which means that a product is under going modifications, repairs, relabeling, or etc. Without having to remove the product completely.
Recalls are made for either the correction or removal of a product from where it is used or sold. They are grouped into three classes depending on their risk of causing serious health problems or death. Labels are super important to ensure that products are utilized correctly. If a hazardous device is used in the incorrect way because labels are peeling off, users are at risk of serious injury. Therefore, a company should definitely recall products with faulty labels to prevent injuries to their customers. In addition to faulty labels, there are more obvious reasons for recalling products such as design or manufacturing issues, but also less obvious reasons such as problems with packaging. According to the FDA, companies recall devices not only by removing them from the market, but also by simply inspecting the device for problems, re-labeling the device, repairing the device, adjusting settings on the device, or monitoring patients that have used the device (website linked below). Therefore, by recalling the device, companies should already be working on improving production methods so that the issue does not happen again. The FDA lists several device recalls here. What are your thoughts on some of these, and what may have caused the faults that led to recalls?
I think that in any situation where there is defect with a product that was produced, from labeling to the product/device itself, there will be a recall. Similar to an example provided by my peer, if a label was smudged on a drug or had come off, it can be a really dangerous situation. For example, lets say a label was illegible at some point of the ingredients section and its just sitting in the pantry. Someone hosts a party and something happens and someone with an allergy to a specific ingredient takes that medicine because it wasn't clear on the label that it was in there. While the smartest thing to do would be to look up if the allergen is in the ingredients, not everyone cares to do so. Recalling labels and providing a public record that you acknowledge that there is a defect that could potentially negatively affect the person using your product saves a lot of headache when people choose to disregard warnings.
