Food and drugs are sensitive topics for most people. This is not surprising because they are vital to maintaining health and wellness. Besides, the impact of anything digested into the body can either affect the body system negatively or positively.
This is why food and drug formulation companies have to go through a strict process to ensure products released are safe for human consumption.
Newly formulated products have to pass through diverse pre-clinal stages and clinical trials to pass quality assurance. After this stage, the formulations need to be translated into writing and then reviewed by top-class experts to pass the final mark—a process called “peer review.”
So, what is peer review and why is it important to submit new food and drug formulation through this process? Let’s take a look.
What Is A Peer Review?
A peer review is a quality assurance method normally used in every field to review research works and ascertain their quality, significance, relevance, and accuracy.
The findings on research works and formulations are then submitted for further investigation by top experts in the said field. Peer review ensures that only research worthy of publications are brought to prominence.
It also brings to light groundbreaking research and ensures that only research-proven to be safe and effective are introduced to the world. You can learn more about the peer-review process in scientific research.
What Are Newly Formulated Food And Drug Products?
Newly formulated foods and drug products are products not immediately introduced to the market for consumption. These products are still in the formulation stage; additional research and testing need to be carried out before they are approved for mass production and distribution.
New products pass through different stages before they are declared ready for mass production and delivery. This is because the consumer’s health and wellness reaction to these products will affect the producer in several ways.
Every day, new formulations for products are in the process of formulation and research. However, until they are approved by the Food and Drug Administration (FDA), they can’t be released for public consumption.
What Does A Peer Review Address?
A standard peer review addresses two specific aspects of any research work. The two paradigms are quality and importance/relevance.
In terms of quality, the peer reviewers need to ascertain that the research on the specified formulation is of high quality. In this segment, the reviewers would analyze the method of conducting the research. They would also look into the research methods, the scope of the study, testing, etc.
After that, they would review the results of the research as well as its conclusions. In this segment, they would also evaluate the credibility and accuracy of the study according to existing paradigms.
Next, the peer reviewers would ascertain the relevance of the research conducted. They would try to understand if the research conducted is relevant and appropriate to the field specified. The possible impact of the study would also be reviewed to ascertain if it would add to existing knowledge.
After conducting a peer review by several experts, the editors still have to make the final decision on the review based on originality, study method, valid data, accurate result, and reasonable conclusion, among other criteria. The final decision would either be “major revision needed,” “minor revision needed,” or “rejection.”
Importance Of Peer Review Research To Newly Formulated Food And Drug Products
Quality is highly crucial to food and drug products because it has to do with the life and health of people. Due to this, the peer review of new food and drug products are painstakingly conducted.
Once the research on the newly formulated food or drug product is completed, the peer review is the next major step.
The validity of the research carried out would be established or invalidated by researchers who are also experts in the field. For instance, research on a new CBD edible has to pass through review by other top experts within the field area.
Even though research has been done and clinical trials have been carried out, a peer review with less than positive feedback could negate the research.
As disappointing as this might sound, it is in the best interest of the researchers, reviewers, and the end-product consumers/users. This is because if a harmful product is released to the public, the backlash would be severe on all parties involved.
The primary purpose of submitting new formulations to peer review is to cross the Ts and dot the Is. This is because researchers tend to turn a blind eye to loops or black holes in their research; it is a normal phenomenon.
The peer review would bring together heads of knowledgeable individuals. In the midst of all this, errors not detected during the research as clinical trial phases would be detected by at least one of the reviewers.
Opens Grounds For Further Research
Peer review brings together the experts in a specific field to review a research. This makes it easier to build on existing research already laid down by the initial formulation.
Valuable feedback is given after the peer review, which would make revisions and improvement of the new product formulation easier and faster.
When it comes to new drug formulations, there is no room for any slip-ups. This is one of the reasons why a coronavirus vaccine is still pending. On each formulation submitted for peer review, there is still a possibility for improvement.
Also, there might be a chance to work with some of the peer reviewers in making a more developed and refined version of the product’s formulation.
Peer-reviewed research is seen as a validation to go ahead with production. Finally, if such formulation finds itself published in a peer-reviewed journal, it offers more credibility to the product as well as the manufacturer.
Helps Detect Flaws in Research
New drugs and food formulations naturally accommodate flaws and hoax results that the original researchers might not easily find. It could be due to getting attached to the product or even anything else.
These flaws and hoax results can affect the validity of the research. A peer review would throw light to reveal flaws, such as biased conclusions, off-point recommendations, false results, overexaggerated claims, not following the due process, and plagiarized work, among others.
Sometimes, these errors might even be purposely engineered to make things work in favor of the product’s manufacturing company. Take into consideration the downfall of erythropoietin-stimulating agents (ESAs).
These ESAs were licensed in the 1990s for treating anemia in cancer patients. At the time, their research publications showed the benefits of treating anemia with just mild negative effects on cancer patients.
It was discovered later that the research publication had been biased about its report of the drug’s actual impact on cancer patients. It was found to cause an increase in the mortality of cancer patients who used it. A peer review of the drug’s research publication would have seen the loopholes.
This would have probably saved the lives of some cancer patients who succumbed to the effect of ESAs. Even if researchers are biased or hiding facts, peer reviewers would be more open about their findings because their integrity is at stake.
Enhances Food And Drug Administration Approval Rate
Getting the approval of the FDA isn’t a walk in the park. Sometimes, it takes up to a year to get a new food or drug product reviewed and approved.
The administration has to ascertain that a new drug or food product is both nutritious and safe because any error that affects human lives would be their call. The FDA review team is saddled with the responsibility of ensuring that the researchers release safe and healthy food and drugs at the end of the day.
Approving the wrong drug or food product for public consumption could lead to a food- or drug-borne disease outbreak. Therefore, the FDA always endeavors to keep review processes strict to prevent saturating the market with counterfeit products.
However, submitting newly formulated drugs and food products for a peer review can pull more weight with the FDA. The peer review would give your product formulation more credibility than a product that has nothing to its name.
For instance, if you are trying to formulate a new wine product for public consumption, a peer review to the product’s name would help the research seem more substantial to the FDA. Even though the FDA and the Alcohol and Tobacco Trade Bureau would still have to do further research before approving your wine for sales, peer-reviewed research can fast-track the process.
In another instance, Epidiolex, cannabis-derived cannabidiol (CBD) product was approved by the FDA in June 2018. It was approved for treating the seizure symptoms of Lennox-Gastaut and Dravet syndrome in patients.
Epidiolex is the first cannabis-derived drug to be approved by the FDA. Although, it was a long journey, having a peer-reviewed research publication to its credit helped push it for approval.
Gives The Public An Assurance Of Safety
No one wants to use a drug or consume food that can harm one’s health. Peer-reviewed research helps reduce the possibility of your new product harming people. Several companies that submit their new formulation product research for review have testified to its importance.
Many have claimed that peer reviews have stopped them from churning out subpar products into the market. Customers would always place more value on a company that endeavors to produce quality and safe products than a company that releases subpar products.
Peer-reviewed research also helps save your time, money, and effort by making you fix all loose ends before mass production of the newly formulated products.
In this era of groundbreaking scientific and technological innovations, a peer review research of your newly formulated product would keep you ahead of your competitors.
Access To Funding And Investors
Yes, peer-reviewed research can grant you more access to funding offers or investment prospects. Due to globalization and innovations in ICT, most companies and factories no longer need to publish the results of their research. Instead, they leave a summary of their research report on their corporate websites.
This means that anyone who visits the websites has access to the information in the report. Besides encouraging transparency, this approach also gives easy access for potential investors to do their research and consider the prospects of investing even before contacting the company.
Besides, in a competitive marketplace like food and drugs, backing new formulations with peer-reviewed research will help it stand out. This is because peer-reviewed research is more credible than a corporate website report summary.
Investors and research organizations will definitely prefer to invest or fund a company that submitted its newly formulated products for peer-reviewed research compared to one that didn’t.
This is how the world works: investors are good at sizing up markets and seizing opportunities. Knowing that your newly formulated product might be the next big thing, they are likely to invest in it. If wielded properly, peer-reviewed formulation research can become a valuable tool that would change the company’s story.
Tips On Buying Newly-Introduced Food And Drug Products
Before buying products, particularly newly-introduced food and drug products, you need to conduct some first-timer checks.
First, try to do a little research before purchasing the product. Find out about the product’s quality certification. Has the FDA approved the product? If so, when? Did it pass through due process and quality assurance tests? Is it certified by accreditation bodies like the ISO? If the product can fully deliver on these questions, then it should safe for consumption.
Also, avoid being blinded by cute packaging. You should check the product’s ingredients before buying it. Check to see if there are any ingredients that can cause allergic reactions. Don’t forget to check for harmful ingredients like sodium nitrate, potassium bromates, carrageenan, and sodium benzoate, among others.
After all, it is something you will be taking into your body. So, you need to be sure the ingredients are safe for consumption.
Finally, try to check for reviews online. No precaution is too excessive when it comes to what you take into your body. Although it might be hard to find online reviews about newly-introduced market products, you can still try and find out about the product and the manufacturer by doing some research or visiting their website.
Peer reviews of research work have sealed their place in the academic field and is now slowly creeping into the industrial scene. By peer-reviewing your newly-formulated food and drug product research works, you can give it the needed credibility to compete with existing products substantively. While peer-reviewed research can be time-consuming and exhausting, it will make the researchers and the newly-formulated product stand out positively.