FDA Class II Recall: Tuscano and Delucia Group's Entropic Labs SARM RAD-140 Marketed Without Approval
Tuscano and Delucia Group (DBA Entropic Labs) initiated a Class II recall for SARM RAD-140 capsules, distributed nationwide. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), containing Selective Androgen Receptor Modulators (SARMs). This highlights critical regulatory compliance failures for procurement and regulatory affairs teams.
FDA Findings: Marketing Unapproved Selective Androgen Receptor Modulators (SARMs)
The U.S. Food and Drug Administration (FDA) initiated a Class II recall (D-0800-2020) concerning Entropic Labs SARM RAD-140, 20mg Capsules, distributed nationwide within the United States by Tuscano and Delucia Group, operating as Entropic Labs. The primary regulatory violation identified was that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This is a fundamental breach of pharmaceutical regulatory requirements, indicating the product had not undergone the rigorous FDA review process to establish its safety, efficacy, and manufacturing quality. For procurement directors, this underscores the critical necessity of verifying the regulatory status of all sourced chemical and life science products, particularly those purporting to have physiological effects. Sourcing unapproved drugs exposes the entire supply chain to significant legal liabilities, product seizures, and severe reputational damage. Regulatory affairs heads must ensure robust internal processes are in place to vet product classifications and marketing claims, especially for compounds like Selective Androgen Receptor Modulators (SARMs), which the FDA has consistently classified as unapproved drugs, not dietary supplements. The presence of such substances in the market without proper authorization represents a direct challenge to public health and regulatory oversight, demanding heightened vigilance from all industry stakeholders.
Facility and Product Profile: Tuscano and Delucia Group's Entropic Labs Operation
Tuscano and Delucia Group, operating under the trade name Entropic Labs, was identified as the recalling firm. Their facility is located at 2150 S West Temple Apt 413, Salt Lake City, UT 84115, within the United States. The recalled product specifically targeted was "Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles," identifiable by UPC#: 651074545302. A total of 60 units of this product were subject to the recall. The FDA classified this product as a 'Drug,' reinforcing the regulatory position that compounds like RAD-140 are not permissible for marketing as dietary supplements or other unregulated categories. For supply chain VPs, this case highlights that even smaller-scale operations, such as Entropic Labs, can introduce non-compliant products with nationwide distribution implications. The relatively small quantity of 60 bottles does not diminish the severity of the regulatory infraction, as the principle of marketing unapproved drugs remains a significant concern. Procurement teams must implement stringent supplier qualification processes that extend beyond large-scale manufacturers to include all potential sources, ensuring comprehensive due diligence on product claims, manufacturing practices, and regulatory compliance status, regardless of supplier size or apparent market footprint.
Supply Chain Exposure: Risks of Unapproved SARM Distribution Across the US
The recall of Entropic Labs SARM RAD-140 was initiated voluntarily by Tuscano and Delucia Group, with initial firm notification via email, and had a distribution pattern described as "Nationwide within the United States." This broad distribution means that various points in the supply chain, from wholesalers to retailers and potentially direct-to-consumer channels, were exposed to an unapproved drug. For supply chain VPs, this event underscores the inherent risks associated with handling products that lack proper regulatory clearances. Downstream formulators, distributors, or even e-commerce platforms that may have unknowingly carried Entropic Labs' SARM RAD-140 could face severe legal repercussions, including product seizures, injunctions, and significant financial penalties. Business development executives must recognize that involvement with such products, even indirectly, can severely damage brand reputation and market access, particularly in highly regulated sectors. The FDA's consistent enforcement actions against unapproved drugs containing SARMs serve as a clear warning that companies must exercise extreme caution and conduct thorough due diligence on all products entering their supply chains to avoid complicity in regulatory violations and safeguard their commercial interests.
Regulatory History and Compliance Trends: Tuscano and Delucia Group's Record
Based on the available source text and knowledge graph context, there is no indication of prior FDA Warning Letters, Form 483 observations, or Import Alerts specifically issued to Tuscano and Delucia Group or its Entropic Labs facility before this Class II recall (D-0800-2020). This suggests that, within the scope of the provided intelligence, this voluntary firm-initiated recall represents the primary documented regulatory action against the company. For regulatory affairs heads, the absence of a documented prior history does not diminish the gravity of the current violation. Marketing an unapproved drug, particularly one containing a Selective Androgen Receptor Modulator (SARM) like RAD-140, is a fundamental breach of FDA regulations that can trigger immediate and significant enforcement. This event serves as a critical reminder that even a company's first regulatory infraction, especially concerning product approval status, can lead to widespread market disruption and necessitate costly recall procedures. Proactive compliance strategies, including rigorous product classification reviews and adherence to Good Manufacturing Practices (GMP), are essential to prevent such foundational regulatory failures, irrespective of a company's past compliance record.
Recall Resolution and Future Regulatory Outlook for Unapproved SARMs
The recall for Entropic Labs SARM RAD-140 was initiated on August 24, 2019, classified by the FDA on January 22, 2020, and officially terminated on July 12, 2023. A 'terminated' status indicates that the FDA has determined that the firm has completed all necessary actions to remove the violative product from the market and has effectively addressed the recall. For procurement and supply chain teams, while the specific recall D-0800-2020 is closed, the underlying regulatory issue of marketing unapproved drugs, particularly SARMs, remains a significant concern. The termination of this recall does not signify FDA approval for SARM RAD-140 or a change in the agency's stance on unapproved SARMs. Regulatory affairs professionals must advise their organizations that continued marketing of such substances without an approved NDA/ANDA would likely lead to further, potentially more severe, enforcement actions, including Warning Letters, injunctions, and criminal penalties. Business development executives should view this event as a clear signal regarding the high regulatory risk associated with products containing SARMs. Any future ventures into categories involving novel compounds must prioritize comprehensive regulatory pathway analysis and secure all necessary approvals to avoid similar costly and reputation-damaging enforcement actions.