Nationwide Product Recall - October 2015
Inaffit, LLC Issues Voluntary Nationwide Recall of Natureal Fat Loss Supplement
Company Contact: Inaffit, LLC
Name: Tiffani S. Smith
Phone Number: (240) 600-0169
FOR IMMEDIATE RELEASE – Date 10/7/2015 Inaffit, LLC is voluntarily recalling all lots of Natureal capsules to the consumer level after FDA laboratory testing found Natureal ‘Burn Fat By Nature’ Supplement to contain sibutramine.
This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established. This product may also interact in life-threatening ways with other medications a consumer may be taking.
Inaffit, LLC notified its customers by email and arranged to receive a replacement product of the new formula Natureal Revert plus a complimentary bottle of Natureal Revert Drops.
Consumers with questions regarding this recall can contact Inaffit, LLC.
Adverse reactions or problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The FDA advised consumers not to purchase or use NATUREAL. Is it safe to use NATUREAL supplements?
NATUREAL is the brand name. At the time the product recall was initiated, on October 5, 2015, we only had one product.
The product that the FDA advised consumers not to purchase or use, NATUREAL ‘Burn Fat By Nature’ is a product that we immediately discontinued.
Inaffit, LLC, maker of NATUREAL, launched a new line of products, that were in development with a chemist prior to the coordination of the voluntary product recall.
The new line of supplements are manufactured in a modern FDA-registered facility.
On October 13, 2015, we launched a new proprietary weight loss formula and expanded the NATUREAL line to include a Body Cleanse, Probiotic, Whey Protein, Herbal Detoxification Tea and Weight Loss Drops to cater to the needs of all customers.
Moreover, we worked closely with the FDA to recall all of the old products.
The FDA closed out/terminated the NATUREAL product recall case on March 14, 2016.
Are NATUREAL products FDA approved?
NATUREAL products are manufactured in a FDA-registered facility.
By law, the FDA does not approve any dietary supplements or vitamins because the FDA does not approve food.
- The FDA treats nutritional dietary supplements as a subset of food products in lieu of drugs.
- The FDA says that dietary supplements are for nutritional purposes only.
- Since dietary supplements are not treated like pharmaceutical drugs, they cannot make claims related to diseases.
- It is the responsibility of each company to ensure that its claims are true and products are safe.
How can I ensure that the dietary supplements that I purchase are safe?
NATUREAL products are manufactured under strict guidelines in a FDA-registered facility in accordance to the FDA’s current Good Manufacturing Practices (cGMPs), which help ensure safety and quality.
NATUREAL products go through comprehensive processes to verify the efficacy and potency of our products.
NATUREAL products are tested by a third party lab verifying that the ingredients listed on the label is what is enclosed in the bottle.
They also test for allergens, contaminants, heavy metals, microbes, and pesticides helping to ensure that our products are compliant with current regulations and guidelines.
Do the FDA monitor supplement manufacturing and labeling?
Yes, the FDA does monitor supplement manufacturing and labeling, and inspects companies regularly to ensure that they are meeting regulations.
If a supplement company doesn’t comply with the FDA regulations, the FDA can ban them from selling their products in the United States.
Do you have a Product Recall Close Out Letter from the FDA to support the termination of the Natureal ‘Burn Fat By Nature’ product recall?
Yes, please see below the official Product Recall Close Out Letter from the FDA.
NATUREAL has made efforts to to prevent confusion regarding the old product versus the new products by changing the product packaging and website url address.
NATUREAL enhanced the formulation of the weight loss pill to include wellness benefits, whereas before only targeted fat loss.
Customers need to have access to reliable, quality and safe health products at the most affordable rate. Addressing certain health conditions such as being overweight, having high blood pressure and high cholesterol is crucial to preventing illnesses such as heart problems, stroke and diabetes.
By providing access to quality products such as NATUREAL supplements, users are one step closer to optimal health and wellness.
A direct quote from NATUREAL CEO & Founder, Tiffani S. Smith:
“Our focus is being transparent, promoting health and wellness and providing safe, quality, premium supplements to our customers.
We will never compromise the safety of our customers, which is why we voluntarily pulled all of our supplements not just the bad batch.”
Smith said regarding NATUREAL’s response to a FDA product recall to protect the health and welfare of their customers.
More information about NATUREAL company and questions about their new products may be addressed to Shanell Lockley, COO through her email at: firstname.lastname@example.org.
NATUREAL is a wellness brand of health products from Inaffit, LLC. Inaffit, LLC launched in 2014 after 3 and a half years of research and testing for the best weight loss supplement.
Inaffit, LLC expanded their supplements to include products such as a slimming detoxification tea, detoxification products, probiotics, liquid weight loss drops, and whey protein under the NATUREAL brand line.
We believe in offering wholistic products to optimize vitality using pure, high quality, whole-food, clinically tested, non-GMO ingredients.
We stand behind the quality of our products and offer a 100% money-back guarantee if you do not absolutely love our products.
More information about Inaffit, LLC and NATUREAL are available at our official site www.natu-real.com and by contacting Shanell Lockley, COO of NATUREAL at email@example.com.