FDA reiterates that ‘FDA approved’ is a bogus phrase in most cases

11-May-2022 - Last updated on 11-May-2022 at 21:39 GMT

©Getty Images - Ildo Frazao

The US Food and Drug Administration has issued a document reminding consumers that in only a few cases is ‘FDA approved’ a factual statement.

‘FDA approved’ language and seals appear on hundreds of dietary supplements and functional food products. The logos and statements imply that the products have received an overarching official government imprimatur, when this is almost never the case.

As far as supplements are concerned, the document reiterates that FDA has no authority to ‘approve’ supplement or food products prior to market. Most of that authority extends to drugs and medical devices, which do in fact have to go through a lengthy procedure to prove that they are safe and effective and in the end are approved for limited, specified uses.

FDA authority does extend to NDIs, claims

Where FDA does have pre market authority is in vetting the safety of New Dietary Ingredients. By law, the developers of such ingredients are required to submit a safety dossier to FDA 75 days before going to market making the case why the ingredient can be reasonable expected to be safe. When this is successful, though, the result is not an ‘approval.’ FDA responds with a letter says that it has ‘no objections’ to the company’s conclusion.

Another requirement is for structure/function claims to be submitted to FDA prior to putting a product on the market with the claim on the label. But FDA does not approve the claims. Federal law merely requires that the claims be truthful and not misleading.

Facilities are inspected, but not approved

Another use of the phrase often appears as ‘made in an FDA-approved facility.’ FDA does of course inspect a small fraction of food and dietary supplement manufacturing facilities each year. When GMP compliance problems are found, which is often the case, they are dealt with via 483 observations, most of which are cleaned up by the companies post inspection. In a few cases this process ends up with the issuance of a warning letter.

And all food facilities are required to register with FDA. If a company were to claim that its products are made in an ‘FDA registered facility’ that would be a factual statement. But it could be construed as a bit misleading, too, as it might imply a distinction where there is none.

In other ingredient categories relevant to the dietary supplement industry the document notes that FDA does approve food additives and food colorants. Food ingredients are in theory vetted to a higher degree of certainty regarding safety than are dietary ingredients, partly because of higher daily intakes.

To conclude, the document stresses that the misuse of FDA’s logo in bogus ‘FDA approved’ statements and seals is a technical violation of the law.

“The FDA’s logo should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service,” the document stated.

Bogus seals problem nothing new

The problem with proliferating, mostly bogus certifications is nothing new. Loren Israelsen, president of the United Natural Product Alliance, has been collecting examples of the many seals used on supplement products, almost all of which are fake.

In recent years this part of the presentations he makes to industry amounts to multiple slides, each chock full of such seals. The takeaway is that while legitimate quality assurances might be in short supply, graphic designers are not.

“For some years I have given presentations on the widespread use of ' brand created ' quality logos and seals. Yesterday's FDA consumer bulletin on what FDA does and does not approve is a helpful guideline for consumers and a reminder that all FDA regulated industries must address the appropriate use of logos or language that could misinform consumers as to the regulated status or quality of products under FDA's jurisdiction,” Israelsen told NutraIngredients-USA.

“Consumer confidence and trust in brands should be based on meaningful and verifiable standards,” he added.

In 2016 UNPA ran a poll in conjunction with an event focusing on the supply chain. More than 81% of respondents said that if some sort of overarching quality program could be initiated within the industry, a new seal denoting that would need to be created, because all of the existing seals have become so compromised.