Warning letter · FDA Warning Letters

JLM Nutritionals, Inc. dba JLM Nutrition, Super Naturals…: FDA Warning Letter 612754 (May 26, 2021)

Agency action: May 26, 2021Record ID: fda_warning_-25f866677f2efaab
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What happened

Original notice title

JLM Nutritionals, Inc. dba JLM Nutrition, Super Naturals Health MARCS-CMS 612754, May 26, 2021

From the archived source record

Reduces risk of Stroke Ulcerative Colitis relief Kidney stone reduction Anti-cardiovascular disease Hypertension reduction (High Blood Pressure) Anti-diabetes via steadying of insulin-glucose balance” • “When taken twice a day, IBSolution not only can diminish your IBS symptoms. . .” On your blog “Natural IBS Treatment Versus Prescription Treatment For IBS Symptoms” page: • “On 04/25/16, Jordyn in Los Angeles wrote: . . . Impaired mental function with people with Alzheimer’s Toxicity from mercury, arsenic, and cadmium Vaginal infections Depression in people with IBS Unhealthy blood-sugar levels in diabetics” Super Naturals Sleep Solution Webpage [see original source] On your product description page under the “Sleep Solution Ingredients” tab, you promote the following ingredients in the product: • “ L-Tryptophane . . . I was able to remove the toxic injectable drug I have taken for decades from my life with our Joint Solution.” On your blog “5 Natural Supplements for Arthritis” page, you promote the ingredients in Joint Solution as providing “natural pain relief,” “targeting inflammation,” and fighting rheumatoid and osteo arthritis. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Super Naturals brand IBSolution, Premium Probiotic, Sleep Solution, Joint Solution, and Ultra Omega Fish Oil products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
a31fb66779b9

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
JOIN THE TENS OF THOUSANDS LIVING IBS FREE; Sleep Solution Ingredients; Joint Solution Ingredients; Our Founders Review; 5 Natural Supplements for Arthritis; Super Naturals brand IBSolution; Premium Probiotic; Sleep Solution; Joint Solution; and Ultra Omega Fish Oil; name implies use for the treatment of Irritable Bowel Syndrome (IBS); description page: • “Omega-3 Fatty Acids
Company
JLM Nutritionals, Inc. dba JLM Nutrition, Super Naturals Health
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.