NATUREAL® Product Safety and Regulatory History

Overview

NATUREAL® is committed to transparency and consumer safety. This page provides factual information regarding a discontinued legacy product from 2015 and explains how current NATUREAL® products and quality standards differ today.

A single product sold in 2015 under the NATUREAL® brand name was voluntarily recalled. That product was permanently discontinued, the recall was formally closed by the FDA in 2016, and it has no connection to any NATUREAL® products sold today.

2015 Voluntary Product Recall (Legacy Product Only)

In October 2015, Inaffit, LLC voluntarily initiated a nationwide recall of a product sold under the name NATUREAL® “Burn Fat by Nature.” FDA laboratory testing identified the presence of sibutramine, a pharmaceutical ingredient not permitted in dietary supplements.

The recall applied only to this specific product and formulation.

Key Facts About the Recalled Product

  • Product name: NATUREAL® “Burn Fat by Nature”
  • Product category: Weight loss supplement capsules
  • Manufacturing date: March 2015
  • Expiration date: March 2017
  • Distribution period: 2015 only
  • Status: Permanently discontinued

Consumers were instructed to stop using the product, and Inaffit, LLC worked directly with the FDA to remove the product from the market.

FDA Recall Closure and Resolution

The voluntary recall of NATUREAL® “Burn Fat By Nature” was formally closed and terminated by the FDA on March 14, 2016.

The FDA confirmed that:

  • The affected product was no longer manufactured or sold

  • Corrective actions had been completed

  • The recall case was closed

This recall is resolved and closed.

What Changed After 2016

Following the recall, NATUREAL® implemented significant changes focused on safety, compliance, and quality.

Corrective Actions and Improvements

  • Permanent discontinuation of the recalled product
  • Development of new proprietary formulations
  • Transition to different manufacturing partners
  • Manufacturing in FDA-registered facilities
  • Implementation of third-party testing protocols
  • Expansion into a broader wellness-focused product line

None of the products currently sold under the NATUREAL® brand are related to or derived from the recalled product.

NATUREAL® Products Today

All NATUREAL® products sold today:

  • Are manufactured in FDA-registered facilities
  • Follow current Good Manufacturing Practices (cGMPs)
  • Are third-party tested to verify label accuracy and ingredient identity
  • Are tested for contaminants such as heavy metals, microbes, pesticides, and allergens
  • Do not contain sibutramine or undeclared pharmaceutical ingredients

Are NATUREAL® Products FDA Approved?

Dietary supplements are regulated as a category of food, not pharmaceutical drugs.

By law:

  • The FDA does not approve dietary supplements prior to sale
  • Manufacturers are responsible for product safety and truthful labeling
  • Facilities are subject to FDA inspection and oversight

NATUREAL® products are manufactured in FDA-registered facilities and comply with applicable regulations.

Our Commitment to Transparency

We believe consumers deserve clear, accurate information about the products they use. That is why we openly document our regulatory history and the steps taken to ensure safety and quality moving forward.

“Our focus has always been transparency, health, and consumer safety. We voluntarily recalled a legacy product, worked directly with regulators, and rebuilt NATUREAL® with higher standards that remain in place today.”
Tiffani S. Smith
Founder and CEO, NATUREAL®

Frequently Asked Questions

Does NATUREAL® contain sibutramine?

No. None of the NATUREAL® products sold today contain sibutramine or any undeclared pharmaceutical ingredients.

Was NATUREAL® recalled?

A single product sold in 2015 under the name “Burn Fat By Nature” was voluntarily recalled. That product was permanently discontinued, and the recall was closed by the FDA in March 2016.

Are current NATUREAL® products related to the recalled product?

No. All current NATUREAL® products are manufactured under different formulations, facilities, and quality systems and are not related to the recalled product.

Are NATUREAL® products FDA approved?

The FDA does not approve dietary supplements. NATUREAL® products are manufactured in FDA-registered facilities and comply with applicable regulations.