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CRITICALNutrition / Supplements

Life Enthusiast Co-op

FDA issued a warning letter to Life Enthusiast Co-op (President Martin Pytela) on August 25, 2025, after reviewing the company's website and finding three ophthalmic products — 'Amazing Colyrio,' 'Fulvic Eyes,' and 'MSM Gold Drops' — marketed with drug claims (treating eye irritation, restoring vision, fighting infections) without FDA approval. The products are classified as unapproved new drugs under section 505(a) of the FD&C Act because they are intended to diagnose, cure, mitigate, treat, or prevent disease and are not generally recognized as safe and effective for their labeled uses. FDA noted particular public health concern because ophthalmic products bypass natural bodily defenses. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Helps maintain comfortable movement and ease in your joints

The silver and gold help fight infections. Zinc and copper speed repairs. Hyaluronic Acid builds flexibility

Supports Joint Comfort[,] Enhances Mobility[,] Aids Connective Tissue Health

Ease Irritations and Infections. [sic] in Eyes, Ears, Sinuses and Skin

Alleviates Eye Irritations

Helps Relieve Eye Strain from Screens and Driving

Aid cellular refreshment. . .. o Support efficient nutrient delivery to delicate eye structures. . .. o Assist the eyes in maintaining a healthy, comfortable state.

Helps alleviate high pressure and pain. Provides a moisturizing and soothing effect within minutes.

STOPS RED EYES[,] ELIMINATES DRY EYES[,] RESTORES VISION

Can be used topically in eyes, nose, ears, throat or other body parts to soothe irritation.

Promotes visual clarity. o Helps soothe and refresh dry-feeling eyes.

Amazing Colyrio helps provide adequate oxygen to eye tissues. And helps restore the electrolyte balance of natural tears.

Soothe Sensitive, Itchy Eyes

Relieves Tired, Strained Eyes

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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