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FDA Warns Shopcalismokes.com Over Unauthorized Zyn Nicotine Pouches

The FDA Center for Tobacco Products issued a warning letter to shopcalismokes.com (Farmington Hills, MI) for offering for sale or distribution two new tobacco products—Zyn Pouches Slim Cool Skittle 15mg and Zyn Pouches Slim Fizzy Cola 15mg—without the required marketing authorization order under Section 910 of the Federal Food, Drug, and Cosmetic Act. FDA determined the products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6) of the FD&C Act. The letter requests a written response within 15 working days describing corrective actions.

Amino Acids and Exercise in FSHD (NCT07543016)

NIH registered clinical trial NCT07543016, evaluating whether amino acid supplementation combined with a structured diet and exercise program improves body composition and physical performance in individuals with facioscapulohumeral muscular dystrophy (FSHD). The study also compares responses between FSHD patients and age- and sex-matched healthy controls. Conditions include FSH Muscular Dystrophy and Muscular Dystrophy; interventions include Essential Amino Acids Supplementation, Exercise, Diet, and Placebo Control.

LTS Therapy Systems Importer Registration Application for Schedule I Controlled Substance

DEA published notice that LTS Therapy Systems, LLC (West Saint Paul, Minnesota) applied on March 6, 2026 to be registered as an importer of Dimethyltryptamine (Drug code 7435, Schedule I). The company plans to import the controlled substance as bulk API for internal research, development, and analytical purposes only. Registered bulk manufacturers and applicants may submit electronic comments or written hearing requests on or before May 18, 2026.

Leading Pharma LLC Controlled Substances Importer Application Notice

The DEA published notice that Leading Pharma LLC, located in Fairfield, New Jersey, applied on March 25, 2026 to be registered as an importer of Diphenoxylate (Drug Code 9170, Schedule II). The company plans to import the controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for FDA approval. Registered bulk manufacturers and applicants may submit comments or objections on or before May 21, 2026.

Inbound Parcel Post Rate Changes at UPU Rates for CY 2027

The Postal Regulatory Commission (PRC) is informing the public of the Postal Service's filing of changes in rates not of general applicability for Inbound Parcel Post (at Universal Postal Union rates) and Inbound International Proof of Delivery, effective January 1, 2027, along with related proposed changes to the Mail Classification Schedule (MCS). The filing reflects amendments to Article 33 of the Universal Postal Convention adopted by the UPU Dubai Congress in September 2025, which allow designated operators to establish self-declared 'Inward Land Rates' beginning in calendar year 2027. The Commission invites public comments on whether the filing is consistent with applicable statutes and policies.

Importer of Controlled Substances Application: Leading Pharma LLC

The DEA published notice that Leading Pharma LLC, 3 Oak Road, Fairfield, New Jersey 07004, applied on March 25, 2026 to be registered as an importer of Diphenoxylate (drug code 9170, Schedule II controlled substance). The company plans to import the listed controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for Food and Drug Administration approval. Public comments on the application and requests for a hearing must be submitted on or before May 21, 2026.

VA Cooperative Studies Program Importer Controlled Substances

The DEA published notice that VA Cooperative Studies Program applied on April 9, 2026, to be registered as an importer of controlled substances for research purposes. The application covers Marihuana Extract (Drug Code 7350) and Tetrahydrocannabinols (Drug Code 7370), Schedule I controlled substances, which the company plans to import as finished dosage unit products for clinical trial studies only. The DEA is accepting electronic comments and written hearing requests on the application through May 21, 2026.