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How FDA compliance requirements can actually give your company a competitive edge.
It’s no surprise that most companies would rather walk over hot coals than to devote time and energy to meeting the requirements laid out by the United States Food and Drug Administration (FDA).
This, of course, is the agency that was created over a century ago to help ensure that certain products sold to consumers were safe. Back then the public often played Russian Roulette when it came to consuming food and medicines that were widely available.
Today, the FDA is responsible for monitoring the safety, efficacy and security mainly of food, drugs, medical devices and cosmetics. It also regulates labeling and advertising, provides information to the public and enforces consumer-protection laws.
The FDA is a big advantage for ethical companies.
While FDA regulations seem burdensome (and they certainly can be), companies that consistently do the right thing with respect to quality and comply with the FDA don’t have to compete against less-than-honorable businesses that put out shoddy products. So in that respect, the FDA levels the playing field.
Also, through their monitoring of product quality, the FDA can help pharmaceutical companies, for example, avoid costly drug recalls as well as lawsuits due to low-quality. Even Johnson & Johnson lost about $600 million in sales when a recall forced them to close a distribution site.
Yes, the FDA’s bureaucracy has gotten gargantuan, and that’s resulted in reams of apparently unnecessary red tape. Still, it remains a reality that companies have to deal with.
Take food producers and packaging as an example.
For safety sake, it’s vital that the packaging in no way compromises a product’s quality, especially when the packaging comes comes in direct contact, whether it’s food, cosmetics or other such product. It’s the possible transfer of chemicals from the packaging to the food that needs to be verified as being safe. Those substances that are not safe are considered to be “indirect food additives.
”There are three possible avenues that food producers can take to achieve compliance, depending on the materials involved.
The first path is the quickest.
If nearly all the ingredients in your food product have prior FDA approval, you’re already way more than halfway there. Materials that have earned multiple approvals include cardboards, plastics, polymeric coatings, additives adhesives. Fortunately, the FDA has compiled this list over many years so it covers a vast array of substances.
The second way: Food-Contact Notification (NCF).
If your product’s packaging contains substances not yet approved Or are approved but being used in a new application, in most cases you will need to provide a Food-Contact Notification.
A formal process for the registration of contact-food materials, this route to compliance requires that you to provide a package of clearly defined, very detailed product information.
This must include information on migration (the packaging transferring chemicals to the product), toxicological information as well as an environmental impact study.If the FDA raises no objections after 120 days, your product will be automatically approved.
Claiming exemptions is the third path.
The FDA exempts a variety of commonly used packaging materials and provides companies with various ways to make claims of those exemptions. Three approaches most often used are prior sanction (i.e., when there’s no objection to a specific use), substances generally recognized as being safe and the no migration exemption (when a substance is not part of the food-contact surface and does not migrate to the food itself).
