Peptide & GLP-1 Fraud Defense
Former DOJ Fraud Section Prosecutors. Nationwide Defense for Peptide Companies, Compounding Pharmacies, Telehealth Platforms, Physicians, and Healthcare Executives Facing FDA Investigations, DOJ Prosecutions, and State Enforcement Actions Involving Peptides, GLP-1s, Research-Use-Only Products, and Unapproved Drug Distribution.
Based in Washington, D.C., Armstrong & Bradylyons PLLC defends peptide companies, research peptide vendors, compounding pharmacies (503A and 503B), outsourcing facilities, telehealth platforms, physicians, clinic owners, and healthcare executives in federal and state investigations and prosecutions involving the sale, compounding, distribution, and marketing of peptides, GLP-1 receptor agonists, and research-use-only (RUO) products.
The peptide and GLP-1 enforcement landscape has transformed. What was once a loosely regulated market is now the target of coordinated enforcement by the FDA, DOJ, the International Trade Commission (ITC), and state attorneys general. In September 2025, the FDA issued more than 50 warning letters to GLP-1 compounders with confirmed DOJ involvement. The FDA raided a major peptide vendor’s warehouse in June 2025. DOJ obtained a guilty plea and $1.79 million forfeiture from Tailor Made Compounding LLC for distributing unapproved peptide drugs, including BPC-157. At least seven research peptide companies shut down in 2025 alone. The “research use only” business model that sustained the peptide industry for a decade is collapsing under enforcement pressure.
The firm’s healthcare fraud defense practice is built on nearly a decade of combined experience at the Healthcare Fraud Unit of DOJ’s Fraud Section. Scott Armstrong served as lead counsel in a $120 million compounding pharmacy fraud case at DOJ involving pharmacy executives, pharmacists, prescribing physicians, and marketers. Scott, Drew Bradylyons, and Andrea Savdie tried 17 federal jury trials in healthcare fraud cases at DOJ involving over $2.8 billion in alleged false and fraudulent claims. DOJ’s new Health and Safety Unit, created in November 2025, now handles criminal Federal Food, Drug, and Cosmetic Act (FDCA) prosecutions. The firm defends individuals in the same enforcement actions that the Fraud Section now brings against peptide companies and compounders.
Armstrong & Bradylyons PLLC defends every peptide and GLP-1 enforcement matter from the start as if it will proceed to a criminal prosecution. Peptide enforcement is escalating from warning letters to criminal referrals. The firm prepares accordingly.
The firm brings direct compounding prosecution experience. Scott Armstrong served as lead counsel in a $120 million compounding pharmacy fraud case at DOJ’s Fraud Section involving pharmacy executives, pharmacists, prescribing physicians, and marketers. That case involved kickback arrangements, formulation manipulation, fraudulent billing, and financial tracing. Scott also served as Director of DOJ’s Appalachian Regional Prescription Opioid Strike Force (ARPO), giving the firm deep experience in controlled substances enforcement. Drew Bradylyons supervised the Healthcare Fraud Unit’s Miami Strike Force and served as Chief of EDVA’s Financial Crimes Unit.
Peptide enforcement is a convergence of FDA regulatory action, DOJ criminal prosecution, ITC exclusion proceedings, and state attorney general enforcement. Most defense attorneys have experience in one of these areas. The firm’s attorneys have spent their careers at the intersection of healthcare fraud enforcement, federal criminal prosecution, and regulatory defense. That background is uniquely relevant as peptide enforcement escalates from regulatory warning letters into criminal territory.
The federal enforcement campaign against the peptide and GLP-1 industry is the most aggressive regulatory crackdown in healthcare since the TRICARE compounding pharmacy wave. It involves every federal enforcement tool: FDA warning letters, FDA facility raids, DOJ criminal prosecutions, ITC exclusion orders, state attorney general lawsuits, and manufacturer-driven litigation. The enforcement is accelerating.
FDA Warning Letters and DOJ Referrals
In September 2025, the FDA issued more than 50 warning letters to companies that compound or manufacture GLP-1 drugs, including semaglutide and tirzepatide. The warning letters targeted false and misleading marketing claims, including claims that compounded products were “generic versions” of FDA-approved drugs. The FDA simultaneously issued warning letters to companies selling peptides labeled “research use only” where advertising indicated the products were intended for human use. These letters targeted semaglutide, tirzepatide, retatrutide, BPC-157, and selective androgen receptor modulators (SARMs). DOJ involvement in these enforcement actions was confirmed.
The FDA also established Import Alert 66-80, a “green list” alert to identify and stop GLP-1 active pharmaceutical ingredients with potential quality concerns from entering the U.S. supply chain. The FDA has increased unannounced inspections of foreign API manufacturers and stepped up remote inspections of overseas peptide suppliers.
Criminal Prosecutions and Facility Raids
DOJ obtained a criminal guilty plea from Tailor Made Compounding LLC for distributing unapproved peptide drugs, including BPC-157. The company forfeited $1.79 million. In June 2025, FDA agents raided the warehouse of Amino Asylum, one of the largest gray-market research chemical vendors, forcing the company offline overnight. DOJ’s new Health and Safety Unit, created in November 2025, assumed responsibility for prosecuting criminal violations of the Federal Food, Drug, and Cosmetic Act, consolidating peptide and compounding prosecutions within the Fraud Section.
Research-Use-Only (RUO) Enforcement
The “research use only” label does not protect sellers whose products are actually intended for human use. The FDA targets RUO peptide vendors whose advertising, packaging, or sales practices indicate that the products are intended for human consumption. Selling peptides with disclaimers that they are “not for human consumption” while simultaneously marketing them through social media targeting consumers, packaging them with diluent and syringes, or providing dosing instructions creates criminal exposure. RUO peptides cannot be used in human or veterinary compounding. The active pharmaceutical ingredient must be pharmaceutical grade, not research grade or food grade.
State Attorney General Enforcement
State attorneys general have stepped into the enforcement gap. Connecticut sued a Florida-based company for selling “research grade” GLP-1 peptides directly to consumers for weight loss without prescriptions or medical oversight. Alabama obtained a temporary restraining order against GLP-1 distributors. More than 40 state attorneys general formally petitioned the FDA about counterfeit peptides entering the U.S. market from China, Turkey, and India. State enforcement is using consumer protection statutes, unfair trade practice laws, and public health authority to pursue companies that operate outside federal drug law.
ITC Exclusion Orders and Manufacturer Litigation
Eli Lilly filed a complaint with the International Trade Commission against multiple research peptide vendors for importing tirzepatide products that infringe Lilly’s trademark. The ITC issued a General Exclusion Order prohibiting all importation of products containing or purporting to contain tirzepatide that infringe Lilly’s trademark. Multiple respondents were found in default. Novo Nordisk has pursued parallel litigation and regulatory pressure against compounders and telehealth companies marketing compounded semaglutide.
FDA Bulk Drug Substance Classifications
The FDA has moved BPC-157, TB-500, and more than 15 other peptides to Category 2 status on the 503A bulk drug substance list, meaning they are classified as substances with safety concerns and are prohibited from compounding for human use. The FDA has also proposed not to include AOD-9604, ipamorelin, MK-677, and CJC-1295 on the bulk drug substances list. These regulatory classifications have direct criminal implications: compounding a Category 2 substance for human use violates the FDCA.
The firm’s defense practice is built on direct compounding pharmacy prosecution experience at DOJ, healthcare fraud trial experience, and deep understanding of the regulatory framework governing peptide compounding and distribution. These tools are deployed at every phase of a case.
Responding to Warning Letters, Inspections, and Criminal Referrals
The firm defends companies and individuals responding to FDA warning letters, Form 483 inspection observations, and import alerts. FDA warning letters are not criminal charges. But they are the first step in an enforcement pathway that can lead to criminal referral to DOJ. The firm develops a response strategy designed to resolve the regulatory matter and prevent escalation to criminal prosecution. Where FDA has already referred the matter to DOJ, the firm provides criminal defense from the outset. The firm also defends companies facing FDA inspections of 503A and 503B compounding facilities.
Defending Against Allegations That “Research Use Only” Products Were Intended for Human Use
The government targets peptide sellers whose RUO disclaimers are contradicted by their marketing, packaging, and sales practices. The firm analyzes every aspect of the business to determine whether the totality of the evidence supports a genuine research-use-only business model or whether the government can prove that the products were intended for human consumption. The firm identifies and addresses advertising, packaging, website content, social media, and customer communications that create exposure, and develops a defense strategy around the actual intended use of the products.
Defending 503A and 503B Facilities in Peptide and GLP-1 Compounding Investigations
The firm defends compounding pharmacies investigated for compounding peptides or GLP-1 drugs outside the legal authority of Section 503A or Section 503B of the FDCA. The government targets pharmacies that compound drugs from bulk substances not on the FDA’s approved list, that compound Category 2 prohibited substances, that compound copies of commercially available drugs outside a valid shortage, or that use RUO or non-pharmaceutical-grade active pharmaceutical ingredients. The firm retains regulatory and pharmaceutical experts to demonstrate compliance with applicable compounding requirements.
Defending Against DOJ Prosecution for Unapproved Drug Distribution and Healthcare Fraud
When a peptide or GLP-1 investigation escalates to a DOJ criminal prosecution, the charges can include distribution of unapproved drugs under the FDCA, healthcare fraud, wire fraud, money laundering, and conspiracy. The firm provides trial-ready criminal defense. Scott Armstrong served as lead counsel in a $120 million compounding pharmacy fraud case at DOJ and tried 16 federal jury trials. He knows how federal prosecutors build and present these cases. The firm develops the defense from investigation through trial.
Federal and state peptide enforcement targets every participant in the supply chain: from the companies that sell peptides, to the pharmacies that compound them, the physicians who prescribe them, the telehealth platforms that facilitate prescribing, and the executives who direct business operations. Armstrong & Bradylyons PLLC defends these individuals in federal and state investigations and prosecutions.
Defense of Peptide Companies and Research Peptide Vendors
The firm defends peptide companies, research peptide vendors, and their owners and executives in FDA investigations, DOJ prosecutions, and state attorney general enforcement actions. Vendors face criminal exposure when the government alleges they sold products labeled “research use only” that were actually intended for human use, marketed peptides with therapeutic claims, packaged products with injection supplies, or failed to register with the FDA as required. The firm defends vendors by analyzing the business model, marketing practices, and customer base to develop a defense around the actual intended use of the products.
Defense of Compounding Pharmacies and Outsourcing Facilities
The firm defends 503A compounding pharmacies and 503B outsourcing facilities in FDA investigations, DOJ criminal referrals, and state pharmacy board proceedings. Compounding pharmacies face exposure for compounding peptides or GLP-1 drugs from bulk substances not on the FDA’s approved list, compounding Category 2 prohibited substances, compounding copies of commercially available drugs after shortages resolved, using non-pharmaceutical-grade APIs, and marketing compounded products with false or misleading claims. The firm defends pharmacies through FDA inspections, warning letter responses, and criminal proceedings.
Defense of Prescribing Physicians and Clinic Owners
The firm defends physicians, nurse practitioners, and clinic owners who prescribe or administer peptides and GLP-1 drugs in anti-aging, regenerative medicine, weight loss, and wellness practices. Physicians face exposure when the government alleges they prescribed unapproved drugs, sourced peptides from non-FDA-registered suppliers, compounded peptides in-house without proper authority, or made therapeutic claims for unapproved peptides. The firm defends physicians by establishing that prescribing and sourcing practices complied with applicable federal and state law and that clinical decisions reflected legitimate medical judgment.
Defense of Telehealth Platforms and Digital Health Companies
The firm defends telehealth companies, digital health platforms, and their executives investigated for facilitating the prescribing and distribution of peptides and GLP-1 drugs. The telehealth GLP-1 market has drawn intense enforcement scrutiny. The government targets platforms that marketed compounded GLP-1 drugs as equivalent to FDA-approved products, facilitated prescribing without adequate clinical evaluation, or used deceptive advertising on social media. The firm defends telehealth executives by demonstrating legitimate clinical oversight, regulatory compliance, and accurate marketing practices.
Defense of API Suppliers and Importers
The firm defends active pharmaceutical ingredient (API) suppliers, importers, and distributors targeted in FDA import alerts and DOJ investigations. The FDA has established Import Alert 66-80 to intercept GLP-1 APIs with quality concerns at the border. Importers face exposure for importing unapproved drug substances, importing products from manufacturers not listed with the FDA, and importing APIs that fail to meet pharmaceutical-grade quality standards. The firm defends importers through customs proceedings, FDA detentions, and criminal investigations.
Peptide and GLP-1 enforcement involves a convergence of federal and state enforcement tools that can escalate rapidly from a regulatory inquiry to a criminal prosecution. Scott Armstrong and Drew Bradylyons built complex healthcare fraud cases at DOJ’s Fraud Section. They understand how regulatory investigations become criminal referrals.
FDA Warning Letters and Inspection Findings
The enforcement pathway typically begins with the FDA. The FDA issues warning letters identifying violations of the FDCA, including false or misleading marketing claims, compounding from prohibited bulk substances, insanitary conditions, and distribution of unapproved drugs. The FDA conducts inspections of compounding facilities (503A and 503B) and issues Form 483 observations. Warning letters and inspection findings are published on the FDA’s website, creating a permanent public record. Failure to adequately respond to a warning letter can trigger escalation to injunctive action or criminal referral.
FDA Criminal Referrals to DOJ
When the FDA determines that violations are willful, repeated, or involve significant patient safety risks, it refers the matter to DOJ for criminal prosecution. DOJ’s Health and Safety Unit, created in November 2025, now handles criminal FDCA prosecutions within the Fraud Section. Criminal referrals target companies and individuals who distribute unapproved drugs for human use, who compound prohibited substances, who market RUO products for human consumption, or who operate in defiance of prior warning letters. The Tailor Made Compounding guilty plea demonstrates that DOJ is pursuing criminal cases against compounders who distribute unapproved peptides.
FDA Facility Raids and Product Seizures
The FDA conducts unannounced facility raids. In June 2025, FDA agents raided the warehouse of a major gray-market peptide vendor, forcing the company offline. The FDA can seek judicial authorization to seize adulterated or misbranded products under the FDCA. Raids and seizures are often coordinated with DOJ and may precede or accompany criminal charges.
RUO Labeling and Marketing Analysis
Federal investigators analyze every aspect of a company’s marketing, packaging, and sales practices to determine whether products labeled “research use only” were actually intended for human use. The government examines website content, social media advertising, customer communications, product packaging, inclusion of injection supplies, dosing instructions, and therapeutic claims. RUO disclaimers do not protect sellers when the totality of the evidence demonstrates that the products were marketed and sold for human consumption.
State Attorney General Investigations
State attorneys general use consumer protection statutes and unfair trade practice laws to investigate and prosecute peptide and GLP-1 companies. States have sued RUO peptide sellers, obtained temporary restraining orders against GLP-1 distributors, and issued statewide notices to clinics and med spas. More than 40 state attorneys general have petitioned the FDA about counterfeit peptides. State enforcement actions can run in parallel with federal investigations and create separate civil and criminal exposure.
ITC Exclusion Proceedings and Manufacturer Litigation
Brand-name pharmaceutical manufacturers pursue parallel enforcement through the International Trade Commission and federal courts. Eli Lilly obtained a General Exclusion Order prohibiting all importation of products containing tirzepatide that infringe Lilly’s trademark. Novo Nordisk has pursued litigation against telehealth companies marketing compounded semaglutide. These proceedings create additional exposure and can generate evidence that federal prosecutors use in parallel criminal investigations.
Import Alerts and Customs Enforcement
The FDA uses Import Alert 66-80 to identify and detain GLP-1 APIs at the border. The FDA has increased unannounced inspections of foreign API manufacturers and remote inspections of overseas peptide suppliers. Customs and Border Protection (CBP) works with the FDA to intercept unapproved drug substances entering the United States. Importers face detention, seizure, and potential criminal referral for importing unapproved APIs.
Peptide and GLP-1 prosecutions draw on a combination of FDCA violations, traditional healthcare fraud statutes, and state consumer protection laws. The enforcement is multi-layered. A single business can face FDA regulatory action, DOJ criminal prosecution, state attorney general enforcement, and manufacturer-driven ITC proceedings simultaneously.
Distribution of Unapproved New Drugs (21 U.S.C. §§ 331, 333)
The primary FDCA charging theory. Section 331 of the FDCA prohibits the introduction into interstate commerce of any new drug that is not approved. Unapproved peptides marketed for human use are unapproved new drugs. Misdemeanor violations carry up to one year. Felony violations, involving intent to defraud or mislead, carry up to three years per count under Section 333. Second offenses or offenses involving death carry up to 10 years.
Adulteration and Misbranding (21 U.S.C. §§ 351, 352)
The FDA charges compounders and sellers with distributing adulterated or misbranded drugs. A drug is adulterated if it is compounded in violation of FDCA requirements or fails to meet quality standards. A drug is misbranded if its labeling is false or misleading, if it lacks adequate directions for use, or if it is marketed with unapproved therapeutic claims. Compounded peptides that use non-pharmaceutical-grade APIs, that are compounded from Category 2 prohibited substances, or that are marketed as equivalent to FDA-approved drugs face adulteration and misbranding charges.
Wire Fraud (18 U.S.C. § 1343)
Wire fraud carries up to 20 years per count. In peptide cases, wire fraud captures the sale of unapproved drugs through interstate wire communications, online sales platforms, social media advertising, and electronic payment processing. Wire fraud carries significantly higher penalties than FDCA misdemeanors and is the statute DOJ uses to escalate peptide cases into serious federal felony prosecutions.
Healthcare Fraud (18 U.S.C. § 1347)
Healthcare fraud is charged when peptide or GLP-1 distribution generates fraudulent claims to Medicare, Medicaid, or private insurance. This includes billing for compounded GLP-1 drugs that were not compounded within legal authority, billing for unapproved peptide treatments, and submitting false prior authorizations. Healthcare fraud carries up to 10 years per count.
Money Laundering (18 U.S.C. §§ 1956, 1957)
Money laundering carries up to 20 years per count. In peptide and GLP-1 cases, money laundering applies when proceeds from unapproved drug distribution are laundered through financial transactions designed to conceal the source of the funds. Tailor Made Compounding’s $1.79 million forfeiture demonstrates that DOJ is pursuing financial penalties in peptide cases.
State Consumer Protection Violations
State attorneys general enforce consumer protection statutes against peptide and GLP-1 sellers. State enforcement actions can result in injunctive relief, civil penalties, temporary restraining orders, and consent decrees. RUO disclaimers do not insulate companies from state consumer protection liability when marketing practices indicate the products are intended for human use. State enforcement runs in parallel with federal investigations.
Seizure, Forfeiture, and Collateral Consequences
The FDA can seek judicial seizure of adulterated or misbranded products. DOJ pursues criminal forfeiture of assets derived from or used in the distribution of unapproved drugs. Compounding pharmacies face loss of state pharmacy licenses and FDA facility registration. Physicians face state medical board disciplinary proceedings. Businesses face permanent reputational damage from FDA warning letters published on the FDA’s website. Payment processors and banks may terminate relationships based on FDA enforcement actions.
Does the “Research Use Only” Label Protect Peptide Sellers from Federal Prosecution?
No. The RUO label does not protect sellers whose products are actually intended for human use. The FDA and DOJ look at the totality of the evidence to determine actual intended use. If a company labels products “research use only” but markets them through social media targeting consumers, packages them with diluent and syringes, provides dosing instructions, or makes therapeutic claims, the RUO disclaimer is treated as a sham. The FDA has specifically targeted RUO peptide sellers whose advertising indicated human use, issuing warning letters in September 2025 targeting semaglutide, tirzepatide, retatrutide, BPC-157, and SARMs.
Connecticut’s attorney general sued a company for selling “research grade” GLP-1s directly to consumers with marketing that explicitly targeted individuals seeking weight loss injections. RUO disclaimers do not create a legal safe harbor when the actual business model is selling products for human consumption.
Can an FDA Warning Letter Lead to Criminal Prosecution?
Yes. An FDA warning letter is a regulatory action, not a criminal charge. But it is frequently the first step in an enforcement pathway that can lead to criminal referral to DOJ. The FDA refers matters to DOJ when violations are willful, repeated, or involve significant patient safety risks. The DOJ Health and Safety Unit, created in November 2025, now handles criminal FDCA prosecutions within the Fraud Section. A company that receives a warning letter and fails to adequately respond, or that continues the violating conduct after receiving a warning letter, faces significantly increased risk of criminal referral.
The firm develops a response strategy designed to resolve the regulatory matter and prevent escalation. Where criminal referral has already occurred, the firm provides criminal defense from the outset.
What Peptides Are Prohibited from Compounding?
The FDA has moved BPC-157, TB-500 (thymosin beta-4), and more than 15 other peptides to Category 2 status on the 503A bulk drug substance list. Category 2 means the FDA has identified significant safety concerns and the substance is prohibited from compounding for human use. The FDA has also proposed not to include AOD-9604, ipamorelin, MK-677, and CJC-1295 on the bulk drug substances list.
Compounding a Category 2 prohibited substance for human use violates the FDCA. Retatrutide cannot be compounded at all because it is an investigational drug. The FDA’s bulk drug substance classifications change based on regulatory review, and providers must continuously verify the compliance status of any peptide compound used in their practice.
What Are the Criminal Penalties for Distributing Unapproved Peptides?
The penalties depend on the charges. FDCA misdemeanor violations carry up to one year per count. FDCA felonies, involving intent to defraud or mislead, carry up to three years per count, or up to 10 years for second offenses or offenses involving death. Wire fraud carries up to 20 years per count. Healthcare fraud carries up to 10 years per count. Money laundering carries up to 20 years per count.
DOJ obtained a guilty plea and $1.79 million forfeiture from Tailor Made Compounding LLC for distributing unapproved peptide drugs. Wire fraud and healthcare fraud charges carry dramatically higher penalties than FDCA misdemeanors and are the statutes DOJ uses to escalate peptide cases into serious federal felony prosecutions.
What Is the Significance of the Tailor Made Compounding Guilty Plea?
The Tailor Made Compounding prosecution is the leading example of DOJ criminal enforcement against a compounding company for distributing unapproved peptides. Tailor Made pleaded guilty to distributing unapproved drugs, including BPC-157, and forfeited $1.79 million. The case demonstrates that DOJ is not limiting peptide enforcement to warning letters and regulatory actions. DOJ is pursuing criminal convictions and financial penalties against companies and individuals who distribute unapproved peptides for human use.
Can Compounding Pharmacies Still Compound GLP-1 Drugs?
The legal pathway has narrowed significantly. During the shortage period, compounding pharmacies were permitted to compound semaglutide and tirzepatide under certain conditions. In February 2025, the FDA declared the semaglutide shortage resolved, ending the broad compounding exception. The remaining pathway for GLP-1 compounding is narrow, technical, and heavily scrutinized. Compounding pharmacies that continued compounding after the shortage resolved face enforcement risk.
The FDA issued more than 50 warning letters in September 2025 targeting GLP-1 compounders. Marketing compounded GLP-1 drugs as “generic” versions of FDA-approved products or making comparative claims is a specific enforcement trigger. Pharmacies that compound GLP-1 drugs should seek legal guidance to evaluate whether their current practices comply with Section 503A and Section 503B requirements.
Are Physicians Who Prescribe Peptides at Legal Risk?
Potentially. Physicians who prescribe or administer unapproved peptides face exposure if the government alleges they prescribed unapproved drugs, sourced peptides from non-FDA-registered suppliers, used RUO or non-pharmaceutical-grade products for patient treatment, compounded peptides in-house without proper authority, or made therapeutic claims for unapproved substances. The FDA has stated that prescribing an unapproved peptide is not “off-label” use because the substance has never been approved for any use.
Physicians in anti-aging, regenerative medicine, and weight loss practices face particular scrutiny. The firm defends physicians by analyzing sourcing practices, prescribing patterns, and marketing materials to establish compliance with applicable law.
What Is Import Alert 66-80 and How Does It Affect Peptide Importers?
Import Alert 66-80 is a “green list” alert established by the FDA in September 2025 to identify and stop GLP-1 active pharmaceutical ingredients with potential quality concerns from entering the U.S. supply chain. The FDA has simultaneously increased unannounced inspections of foreign API manufacturers and stepped up remote inspections of overseas peptide suppliers.
Importers whose shipments are flagged under Import Alert 66-80 face detention of their products at the border. Detained products may be refused admission to the United States. Repeated importation violations can lead to criminal referral. The firm defends importers through customs and FDA detention proceedings and coordinates with criminal defense counsel where DOJ involvement is present.
How Do ITC Exclusion Orders Affect Peptide Vendors?
The International Trade Commission has issued exclusion orders that prohibit the importation of products containing tirzepatide that infringe Eli Lilly’s trademark. A General Exclusion Order applies to all importers, not just named respondents. Vendors who import or sell products covered by an ITC exclusion order face seizure by Customs and Border Protection. Violation of an ITC exclusion order can also create exposure for criminal contempt and related charges.
ITC proceedings generate evidence and findings that federal prosecutors can use in parallel criminal investigations. The firm defends peptide vendors in ITC proceedings and coordinates the defense of parallel federal and state enforcement actions.
Does Armstrong & Bradylyons Handle Peptide and GLP-1 Cases Nationwide?
Yes. Armstrong & Bradylyons PLLC defends individuals and companies in federal and state peptide and GLP-1 investigations and prosecutions in every jurisdiction. Enforcement is active nationwide. FDA warning letters have targeted companies across the country. State attorneys general in Connecticut, Alabama, and dozens of other states have initiated enforcement actions. DOJ prosecutions originate from multiple federal districts.
Scott Armstrong served as lead counsel in a $120 million compounding pharmacy fraud case at DOJ and tried 16 federal jury trials. Drew Bradylyons supervised healthcare fraud prosecutors at DOJ and oversaw complex fraud cases as Chief of EDVA’s Financial Crimes Unit. The firm is based in Washington, D.C. and represents clients in every jurisdiction where the FDA, DOJ, the ITC, and state attorneys general bring peptide and GLP-1 enforcement actions.