New FDA Approved Non Opioid Pain Medication Could Reshape Pain Management
For decades, opioid painkillers have been the go-to option, despite their high risk of addiction. Patients and doctors have long sought safer alternatives, but non-opioid options have remained limited.
Now, the FDA has approved suzetrigine (Journavx), a non-opioid pain medication that blocks acute pain signals without addiction risks. This breakthrough offers new hope for patients and a safer alternative to opioids.
For Amazon sellers, the challenge lies in navigating Amazon’s strict prescription drug policies. While Amazon Pharmacy sells prescriptions, many struggle to access the program.
This approval is promising for patients and consumer, but Amazon sellers should explore if it’s a viable business opportunity.
Should Sellers Sell Journavx on Amazon?
With new FDA approved non-opioid pain medication, Amazon sellers may wonder if they can list it. However, Amazon only allows over-the-counter (OTC) pain relievers, while prescription drugs are restricted to Amazon Pharmacy—a platform with limited accessibility for third-party sellers.
Challenges for Selling Journavx on Amazon
- Prescription-Only Restrictions – Journavx requires a doctor’s prescription, preventing standard Amazon listings.
- Limited Amazon Pharmacy Access – Many pharmacy owners struggle to get clear guidance from Amazon on participation.
- Regulatory Compliance – Selling prescriptions involves strict federal and state regulations, adding complexity.
Alternatives for Sellers to Explore
- Partnering with Local Pharmacies to distribute Journavx.
- Exploring Online Pharmacy Platforms like GoodRx or Walgreens.
- Direct-to-Consumer Sales via licensed online pharmacies.
Amazon’s restrictions make selling Journavx difficult for most sellers. Until Amazon improves third-party pharmacy access, sellers should consider alternative pharmacy marketplaces for distribution.
Venturing Into Pharmacy E-Commerce
The pharmaceutical industry has been slower to embrace digital transformation compared to other sectors, mainly due to strict legal regulations and the nature of its goods. However, the shift towards eCommerce, accelerated by the pandemic, has reshaped consumer behavior and driven rapid growth in online pharmaceutical sales.
The Growth of Pharmacy E-Commerce
The online pharmaceutical market, currently valued at approximately $75.5 billion in 2024, is expected to grow significantly. With a projected annual growth rate of 14.4%, the market’s total value is forecast to reach nearly $290.8 billion by 2034.
Svetlana Golubeva"The pharmaceutical B2B eCommerce market is thriving and shows a growing appetite for digital commerce models..."
The rise of digital-first pharmacies such as PocketPill, Pillway, and Medly further reflects the changing landscape. Even pharmaceutical giants like Pfizer and Eli Lilly have launched direct-to-consumer (DTC) online pharmacies to bypass intermediaries and control pricing and distribution.
Selling OTC Drugs on Amazon: An Opportunity for Sellers
For Amazon sellers looking to enter this space, selling OTC drugs presents a viable opportunity. While prescription drugs are restricted to Amazon Pharmacy, OTC medications can be sold by third-party sellers—provided they comply with Amazon’s strict guidelines.
Key Considerations for Selling OTC Drugs on Amazon
Selling OTC pain relievers on Amazon can be a profitable venture, but it requires careful planning and strict compliance with Amazon’s policies and legal regulations on ingestible OTC pain relievers.
Statista"Amazon is the second top online retailer for over-the-counter (OTC) medicine shoppers."
1. Regulatory Compliance is a Must
Amazon requires all ingestible OTC pain relievers to meet federal, state, and local laws. Sellers must ensure their products comply with:
- 16 CFR Part 1700 (Poison Prevention Packaging Act)
- 21 CFR 207 Subpart C (National Drug Code requirements)
Additionally, products must be tested and certified by an ISO 17025 accredited lab, ensuring compliance with safety and packaging regulations.
2. Required Documentation
Amazon may request compliance documentation at any time. Sellers should have the following readily available:
✔ Company name and Seller ID
✔ Contact details (email & phone number)
✔ A full list of OTC pain relievers being sold
✔ Product images showing all sides of the packaging
✔ Product labels that comply with Amazon’s OTC drug policy
✔ A General Certificate of Conformity (GCC)
✔ Lab test reports proving compliance with safety regulations
Failing to provide these documents can result in listing removals, account suspension, or withheld payments.
3. Packaging and Labeling Standards
Amazon has strict packaging and labeling requirements for OTC drugs to ensure accuracy, compliance, and consumer safety. Sellers must meet the following standards:
- Clear Labeling – Packaging must display dosage instructions, active ingredients, and safety warnings.
- Complete Product Images – Listings must include high-quality images showing all sides of the packaging.
- Accurate Product Detail Pages – Information must match the actual packaging and comply with Amazon’s OTC drug policies.
4. Submitting Compliance Documents
If Amazon requests compliance documentation, sellers must follow the steps outlined in this video:
Proper submission helps avoid penalties and product removals.
5. Amazon’s Policy Enforcement is Strict
Amazon actively monitors OTC drug listings. If a seller does not provide required compliance documents, Amazon may:
🚨 Remove product listings
🚨 Suspend listing privileges
🚨 Withhold payments
To avoid disruptions, sellers should stay updated on policy changes and ensure all compliance documents are in order.
Challenges of Selling OTC Drugs on Amazon & How to Overcome Them
Here are the key challenges sellers can expect to face and how to address them.
1. Compliance & Regulatory Hurdles
Challenge: Amazon requires OTC drugs to meet federal, state, and Amazon-specific regulations. Sellers must provide lab test reports, a General Certificate of Conformity (GCC), and ensure proper labeling and packaging. Missing any requirement can result in listing removal.
Solution:
✔ Keep compliance documents ready and regularly update them.
✔ Work with ISO 17025-accredited labs to ensure proper testing.
✔ Use Amazon’s service provider network for assistance with certification and audits.
2. Listing Suspensions Due to Prohibited Claims
Challenge: Amazon has strict wording policies for OTC drug listings. Using phrases like “pain relief” and “cures” can lead to yanked or suspended listings due to misleading medical claims.
Solution:
✔ Use compliant language by focusing on product features, not medical promises (e.g., “supports joint comfort” instead of “relieves joint pain”).
✔ Check Amazon’s policy on drugs and drug paraphernalia for approved phrasing.
3. Troubleshooting Suspended or Removed Listings
Challenge: Listings may be removed due to compliance issues, incorrect wording, or missing certifications. Sometimes, sellers struggle to get clear answers from Amazon Seller Support.
Solution:
✔ Regularly check Account Health in Seller Central to address compliance alerts quickly.
✔ Submit missing documents through Product Compliance Requests to reinstate listings.
✔ If a listing is wrongly suspended, sellers can file an appeal with supporting documents.
4. Competitive Pricing & Product Visibility
Challenge: The OTC drug market is competitive, and high-priced products may struggle against big-name brands. Listings with poor SEO optimization also fail to attract buyers.
Solution:
✔ Use Amazon keyword research tools to identify high-ranking, policy-compliant search terms.
✔ Consider Amazon Advertising (PPC campaigns) to boost product visibility.
✔ Offer subscriptions or multi-pack discounts to improve competitiveness.
Sellers can tackle these challenges independently, but partnering with an Amazon agency—which has specialists focused on account management and growth—can be a more effective solution. An agency can help navigate compliance rules, enhance product listings for better visibility, resolve listing issues, and optimize pricing and advertising strategies to maximize sales.
