Homeopathic Regulation in the United States

The Federal and state regulations over homeopathic products are complex and draw from three primary regulatory sources: The FDCA (Food, Drug and Cosmetic Act) and its regulations, the Homeopathic Pharmacopeia of the United States (HPUS) and the homeopathic drug Compliance Policy Guide (CPG). These different sets of regulatory sources cover ingredients, labeling, adulteration, etc… but they do not exempt homeopathic products from all of the FDCA or FDA drug regulation requirements. In fact, homeopathic products are regulated as drugs by FDA, thus complicating the regulatory and labeling requirements.

Unique Aspects of Homeopathic Regulation

Because homeopathic products are regulated as drugs, they must meet the applicable requirements specific to them to be marketed without new drug application approval. If a product does not meet the criteria, then it will require FDA approval before it may be marketed in the United States. Homeopathic products (drugs) may be over the counter (OTC) or prescription depending on their active ingredients and intended uses. Homeopathic drug dosages are based uniquely on principles of serial dilution (attenuation) and must be marketed in strengths that indicate how many dilutions the product has undergone in the manufacturing process. Many homeopathic manufacturers and importers incorrectly assume that they will have an easier time with their labeling compliance due to the assumption that there are fewer overall laws to deal with. This is not the case. In fact, the regulations governing homeopathic OTC drugs are more complex than more traditional OTC drug products because of the three various regulatory sources that apply to them. Understanding which regulations apply, which don’t, and what to do with conflicting regulations can be overwhelming. HomeopathicLabelRight.com is the way for you to cut through the maze with a few simple clicks.

Homeopathic Labeling Requirements

Labeling is essential to the successful distribution of any highly regulated product in the United States. But this is especially true for natural products like homeopathic drugs. Several significant Federal cases have been brought against the marketers of homeopathic drugs and many involved improper labeling. If you’ve ever picked apart a homeopathic product’s packaging then you’ll know just how important the claims are as a selling point. Claims such as “all-natural,” “remedy” or even “helps with the symptoms of…” are all popular and widely used in homeopathic marketing, yet are all claims which can be seen as red flags from the FDA’s perspective. The Drug Facts Panel is an instant source of concern from FDA’s perspective as there are a host of opportunities for incorrect labeling in the panel. Areas such as “Active Ingredients,” “Warnings” and “Directions” are all important and required components of your drug labeling which could cause your product to be stopped and prevented from entering U.S. distribution. Additionally, if your product does not comply with the HPUS, FDA regulations and the CPG, your product can be classified as an unapproved, misbranded or adulterated drug resulting in FDA civil actions (seizures) or for imported products, possible FDA detention, Import Alert or refusal. Don’t let this happen.

Other Facts About Homeopathic Products

  • The Homeopathic Pharmacopoeia of the United States has been in continuous publication since 1897.
  • A homeopathic product’s declaration of potency must contain the statement of quantity and amount of ingredients in the product (in homeopathic terms)
  • Latin ingredient names may be used in the ingredients list but only if accompanied by their English translations.
  • Firms that manufacture or process homeopathic drugs must register as a drug establishment with the FDA. Additionally, homeopathic drug products need to be listed with FDA.

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