If the FDA Didn’t Approve It, Why Is It Still Being Sold?

Understanding NDIs, FDA Rejection Letters, and the Regulatory Loophole

When people hear that the FDA reviewed a product and found serious safety concerns, the natural assumption is simple: that product must be illegal to sell.

Unfortunately, in the world of dietary supplements, that assumption is often wrong.

This post explains:

• what an NDI (New Dietary Ingredient) notification actually is,
• what Johnson Foods submitted to the FDA for its product,
• what the FDA said in response, and
• why the product can still legally appear on store shelves despite FDA objections.

What Is an NDI (New Dietary Ingredient) Notification?

Under federal law, dietary supplements do not require FDA “approval” before being sold.

Instead, if a company wants to market a new dietary ingredient—one not sold in the U.S. before October 15, 1994—it must submit an NDI notification to the FDA at least 75 days before marketing.

That notification must include:

• a clear identification of the ingredient,
• manufacturing and composition information, and
• evidence that the ingredient can reasonably be expected to be safe under labeled conditions of use.

Importantly:

• An NDI is not an approval process
• FDA does not certify, endorse, or authorize the product
• FDA only reviews whether the submission adequately supports safety

If the submission is inadequate, the ingredient is considered adulterated under federal law.

What Johnson Foods Submitted to the FDA

In October 2022, Johnson Foods LLC submitted an NDI notification for a product it called “NPI-001, a dried kratom leaf powder,” intended to be sold under the name Mitra-Leaf.

According to the company:

• the ingredient was dried kratom leaf powder,
• the proposed dose was 50 mg per day,
• use was limited to 15 days per month, and
• the product was intended for adults only.

Johnson Foods included:

• manufacturing descriptions (many marked confidential),
• toxicology summaries,
• animal studies,
• a short human exposure study, and
• extensive literature citations attempting to argue low-dose use is safe.

They concluded that their product could be “reasonably expected to be safe” under those conditions.

What the FDA Said in Its Response

On January 4, 2023, the FDA issued a formal response letter to Johnson Foods—and it was not favorable.

In plain terms, the FDA said:

1. The Product Was Not Adequately Identified

The FDA stated it could not establish the identity or composition of the ingredient based on the information provided. Without clear identity data, FDA could not determine whether the studies cited actually applied to the product being sold.

2. Safety Was Not Established

FDA explicitly concluded that the submission failed to demonstrate reasonable safety. The agency cited concerns including:

• tolerance and physical dependence,
• abuse potential,
• withdrawal symptoms,
• neurotoxicity and memory impairment,
• drug–drug interactions, and
• reported cases of serious injury and death.

3. The Product May Be Adulterated Under Federal Law

Because Johnson Foods failed to meet the statutory safety standard, FDA concluded that a product containing this ingredient may be considered adulterated under the Federal Food, Drug, and Cosmetic Act.

The letter states that introducing such a product into interstate commerce is prohibited under federal law.

This is not a neutral or ambiguous letter—it is a formal regulatory rejection.

So Why Is It Still Being Sold?

This is the most important question—and the answer exposes a major flaw in U.S. supplement law.

The FDA Does Not Automatically Stop Sales

Under the Dietary Supplement Health and Education Act (DSHEA):

• companies are allowed to self-determine safety,
• FDA must take affirmative enforcement action to stop sales, and
• no automatic recall or ban occurs when an NDI is rejected.

In other words:

• A failed NDI does not automatically remove a product from the market
• FDA must pursue enforcement case-by-case
• Enforcement requires time, resources, and prioritization

FDA Enforcement Is Reactive, Not Preventive

The FDA’s tools include:

• warning letters,
• product seizures,
• injunctions, and
• referrals to the Department of Justice.

But these actions typically happen after harm occurs, not before.

Unless a state acts independently—or FDA escalates enforcement—the product can remain on shelves even after FDA concludes it is unsafe.

What This Means for Policymakers

This case illustrates a critical policy reality:

• A product can fail FDA’s safety review
• Be considered potentially illegal under federal law
• And still be sold nationwide

The burden is not on companies to prove safety before sale—it is on regulators to prove harm after the fact.

This is why many states have begun acting on their own, using:

• food adulteration laws,
• controlled substance statutes,
• consumer protection authority, and
• public nuisance frameworks.

Bottom Line

• An NDI submission is not approval
• Johnson Foods submitted an NDI for a product
• The FDA found the submission inadequate and unsafe
• The FDA warned the product may be adulterated and illegal
• Yet the product can still be sold due to federal enforcement gaps

This is not a failure of science—it is a failure of regulatory structure.

Until lawmakers address this loophole, FDA rejection letters will continue to coexist with retail sales, and consumers will continue to assume “FDA-reviewed” means “FDA-approved.”

It does not.