OTC & Homeopathic Drug Consultation

Over-the-counter (OTC) drugs make up a large part of the drug market. You likely use OTC drugs every day – your toothpaste, antiperspirant, and headache medicine are all OTC drugs. Not only is this market large, but it is also easier to enter than the new drug and prescription drug market. The two main kinds of OTC drugs are:

• Monograph drugs
• Homeopathic drugs

Neither requires a premarket New Drug Application (NDA) approval from the Federal Drug Administration (FDA), but both require intimate knowledge of the FDA drug system (labeling, registration, formulation, etc.). Having an attorney with experience in all parts of the OTC drug system will enable you to navigate the FDA’s requirements while understanding, mitigating, and evaluating your regulatory risks. At MyFDALawyers.com, PC, our FDA attorneys have extensive experience with OTC drug regulations and homeopathic drug policy. Contact us today for a confidential consultation.

An Overview of FDA Regulations of OTC Monograph Drugs

One of the most important points for businesses to understand about OTC Monograph Drugs is that they are drugs that require no prior FDA approval. In effect, the FDA has already approved the drug active ingredient and permitted claims, so any company making a product conforming to the monograph’s formula and labeling requirements may enter the market. It is a process that creates a faster, more cost-effective pathway for companies to launch over-the-counter products. That is provided that they stay within the parameters outlined in the applicable monograph.

Monograph Drugs include various topical and ingested drugs like toothpaste, antiperspirants, sunscreens, cough medicines, headache medicines, and eye drops. Monograph Drugs also include types of combination cosmetic drugs, such as face cream with SPF. These monographs specify allowable active ingredients, approved forms, the route(s) of administration, any required warning labels, and the approved uses. Any deviation from a monograph, such as using an unapproved ingredient or making additional claims, requires a New Drug Application (NDA).

The keys to getting into this market include compliant formulation, labeling, facility registration, drug listing, and drug Good Manufacturing Practices (GMP). Businesses must also monitor regulatory updates, as the FDA may revise or eliminate existing monographs through its OTC Monograph Reform process. Full compliance is an absolute must. If you have any questions about the process for OTC monograph drugs, an experienced FDA lawyer can help.

An Overview of FDA Regulations of OTC Homeopathic Drugs

Homeopathy is a form of medicine from the 1700s. It is based on the idea that consuming a tiny amount of an herbal substance that causes symptoms can cure the same symptoms. However, in common parlance, homeopathy is seen as just natural or herbal medicine. These remedies are often derived from botanical, mineral, or animal substances and are heavily diluted in their final form. In some cases, to the point where little (if any) molecules of the original substance remain.

The FDA takes no stand on the validity of this methodology and generally permits homeopathic products, provided they do not target vulnerable people or endanger public health by claiming to treat serious medical problems. An important point for businesses in this industry to be aware of is that the FDA issued updated guidance in 2022 that prioritizes heightened enforcement action against homeopathic products that are marketed for serious diseases and for those products with significant safety concerns. Products making high-risk claims—such as cancer cures, opioid addiction treatments, or infant remedies—are more likely to face strict scrutiny.

While the FDA takes an open approach to homeopathic products, the Federal Trade Commission (FTC) can be openly hostile. The FTC insists that labels and advertising of homeopathic products contain an “unscientific” disclaimer on all homeopathic claims unless you have significant premarket scientific evidence. The FTC’s position is rooted primarily in consumer protection laws. These regulations require that health-related claims be substantiated by competent and reliable scientific evidence. In practice, this means that many homeopathic products must include disclaimers stating that the product is not approved by the FDA, there is no scientific proof that the product works, and/or that the claims are based on traditional theories and not modern medicine.

Homeopathic Market

The market for homeopathic products is still wide open and homeopathic products can be marketed for treatments that dietary supplements cannot. However, homeopathic product manufacturers need to be careful to comply with FDA OTC drug requirements and FTC marketing restrictions.

Hiring an experienced FDA attorney can help you thread the needle of FTC and FDA compliance to bring your traditional and/or innovative homeopathic product to market. If you are preparing to bring an OTC homeopathic product to market, our FDA/FTC lawyers are available to help.

OTC & Homeopathic Drug Consultation Terms to Familiarize Yourself With

Businesses that operate in the homeopathic drug market and the over-the-counter monograph drug market should be aware of the terms used by industry regulators who assess labeling and marketing. Learning these terms will help you understand drugs as the FDA does. Here are some of the most notable terms:

• OTC –Over-the-counter, meaning that the drug can be purchased without a prescription from a doctor. A wide range of drugs— some approved, some monograph, and some homeopathic—fall into the category of OTC products.
• Monograph – An FDA-created regulation that outlines the formula and labeling required to market a particular drug without approval and without a prescription. See the FDA monographs here. These regulations function like a pre-approval template. They allow compliant drugs to bypass the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) process. Products that do not strictly conform to an applicable monograph are considered misbranded or unapproved.
• HPUS – The Homeopathic Pharmacopoeia of the United States (HPUS), which is the official compendium of homeopathic ingredients in the U.S. HPUS is issued by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), which is a non-government agency that advocates for and helps to systematize the industry. Inclusion in the HPUS requires documentation of traditional use, preparation methods, and safety standards. However, listing in the HPUS does not mean an ingredient is FDA-approved.
• Homeopathic Monograph – HPCUS-issued descriptions of homeopathic active ingredients. These monographs, unlike FDA-issued monographs, do not set forth the terms under which a drug may be legally marketed. They serve as quality benchmarks within the homeopathic industry, detailing dilution methods and source materials.
• Drug Facility Registration – A registration for drug facilities. All drug manufacturers, repackers, relabelers, and salvagers are required to register each facility with FDA. This includes foreign facilities that offer drugs for import into the U.S. Additionally, foreign facilities need to identify each U.S. importer and a US Agent for contact with FDA. Registrations must be updated annually between October 1 and December 31 and are submitted electronically to the FDA.
• Drug Listing –Each drug that a drug facility manufactures, repacks, relabels, or salvages for commercial distribution. Drug listings include label proofs and are public. See at Daily Med. Each listing must be submitted electronically. They include information such as the National Drug Code (NDC), dosage form, and strength.
• Drug Facts – The required panel on all OTC drugs that includes the drug concentration, indications for use, directions, counterindications, inactive ingredients, and storage requirements. The format and language are strictly regulated to ensure clarity and consistency across all OTC products.
• Homeopathic – As defined by the Homeopathic Pharmacopoeia Convention of the United States, homeopathy is “the art and the science of healing the sick by using substances capable of causing the same symptoms, syndromes, and conditions when administered to healthy people.”

We Help Businesses with Market Entry (OTC and Homeopathic Drugs)

Our team has considerable experience with market entry. Successfully launching an over-the-counter (OTC) or homeopathic drug requires careful compliance with FDA regulations. Whether your product is regulated under the OTC monograph system or is a homeopathic remedy subject to the FDA’s Homeopathic Drug Products Guidance, navigating the path to lawful distribution can be a challenge. Our FDA lawyers help businesses nationwide both understand their obligations and meet all of the requirements for lawful market entry. Along with other things, our OTC and homeopathic drug lawyers have experience with:

• Product Classification Analysis: We will determine whether your product qualifies as an OTC drug, a homeopathic product, or a different FDA-regulated category.
• Labeling and Claims Review: We will ensure your packaging and marketing comply with FDA regulations and avoid unapproved drug claims.
• Monograph Compliance Support: We can determine whether their OTC product conforms to an existing monograph or requires a New Drug Application (NDA).
• Homeopathic Product Review: We advise on compliance with the FDA’s risk-based enforcement approach to homeopathic drugs.

Navigating Product Compliance Requirements for OTC Monograph Drugs and Homeopathic Drugs

OTC monographs and homeopathic drugs must meet strict product compliance standards to remain legally on the market. The FDA monitors everything from active ingredient concentrations to manufacturing processes and marketing claims. Failure to comply can lead to warning letters, import detentions, product recalls, or other enforcement action. Our FDA lawyers have the skills, knowledge, and experience to help businesses nationwide navigate the full range of product compliance standards. Along with other things, our FDA lawyers are ready to assist you with:

• Ingredient and Formulation Review: We will confirm that all active and inactive ingredients comply with applicable FDA monographs or policies.
• Good Manufacturing Practice (GMP) Compliance: We can advise on compliance with FDA’s cGMP regulations under 21 CFR Part 210/211 for OTC drugs.
• Labeling Compliance: We can evaluate drug facts panels, directions for use, warnings, claims, and branding to ensure FDA-compliant labeling.
• Risk-Based Review of Homeopathic Products: We are prepared to guide clients under the FDA’s revised enforcement approach, focusing on safety, intended use, and vulnerable populations.
• Ongoing Compliance Monitoring: Finally, we support clients with serious adverse events reporting, FDA inspections, and updates as FDA rules and policies evolve.

How an FDA Attorney Can Help

Over-the-counter (OTC) and homeopathic drug regulations can be complicated. You do not have to figure out everything on your own. Bill Senior and Rick D. Quinn have decades of experience handling the full range of issues for FDA-regulated products, including issues involving OTC drugs and homeopathic drugs. We can help you prepare to enter the U.S. OTC drug market, including classification, formulation, registration, labeling, and importation. We also help you stay in the market through advocacy. We have years of experience representing our clients with the FDA, Customs, DEA, and other agencies. When you reach out to our office, you will have an opportunity to consult with an FDA lawyer who can:

• Listen to your story and answer your most pressing regulatory questions
• Guide you through market entry
• Help you stay ahead of requirements needed to stay in the market
• Advocate for you in any interaction with FDA