The Anatomy of a Compliant Homeopathic Label
By Eric L. Foxman, R.Ph., AAHP Secretary
Before examining the details of a compliant homeopathic drug product label, it is important to consider labeling in relation to the FDA Draft Enforcement Guidance.
Intended Use Statements
In the Draft Guidance, FDA notes they will exercise a risk-based approach to enforcement with particular emphasis focused on six areas. One areas directly impacts labeling: FDA generally intends to prioritize enforcement and regulatory actions [against] “products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions.”
Through many warning letters, FDA has clearly signaled what kinds of diseases and conditions it considers to fall into this category, such as:
Blood poisoning
Cancer
Chickenpox; measles; mumps
Depression
Diabetes
Dysentery
Hardening of the arteries
Herpes
High cholesterol
Hypertension
Impotence
Influenza
Injury to nerve
Liver congestion and dysfunction
Liver disorders
Migraine
Neuralgia (nerve pain)
Rheumatoid arthritis
Severe chronic pain
Thyroid Insufficiency
Tinnitus
Ulcerated intestinal surfaces
Vaccination-Illness
Vertigo
Viral infections
It’s also pertinent to note that, since the Acting Secretary of Health and Human Services (HHS) declared a public health emergency involving the opioid crisis, FDA has treated the marketing and sale of unapproved opioid addiction treatment products as a potentially significant threat to the public health. FDA has used this circumstance to issue warning letters for products for other types of addictions, including alcohol.
One final preliminary point: In light of the COVID-19 crisis, FDA has a very active special operation, entitled Operation Quack Hack. Within just a few weeks, the agency discovered hundreds of products sold online that fraudulently claim to mitigate, prevent, treat, diagnose, or cure COVID-19. These include fraudulent drugs, testing kits, and personal protective equipment (PPE). Remember, internet marketing is an extension of labeling; all of these products are misbranded and subject to serious enforcement action, including (at the time of this writing) eight homeopathic products.
On the subject of internet marketing, FDA has also issued warning letters to companies whose websites make effectiveness claims, but which lack adequate descriptions of the risks, warnings, and contraindications of the product. Further, warning letters were issued based on evidence of the intended use given by personal testimonials and through wording such as “users report….”
Labeling Requirements
In addition to FDA’s labeling requirements in 21 CFR, there are also Homeopathic Pharmacopeia (HPUS) Labeling Guidelines* that address circumstances that might be unusual in the broader pharma world, but that are not uncommon in the homeopathic sub-universe.
If the container is too small to include all required statements, the HPUS gives guidance as to the minimum information that must appear on the label:
- Statement of identity of the homeopathic drug product (HDP); this is the official name, or the established short name, in the current HPUS.
- Attenuation of the HDP
- Lot or control number
- Name of manufacturer, packer or distributor
- All other required information must appear on outer carton, or a leaflet inside package.
The labeling of all homeopathic drugs must include:
- The attenuation level and quantity of each HDP in the package.
- Must state, in prominent type, “Homeopathic” or Homœopathic”.
- The letters “HPUS” are restricted; they may only be used for HDPs approved for publication in current HPUS. They must also state: “The letters ‘HPUS’ indicate the component(s) in the product is (are) officially monographed in the Homeopathic Pharmacopia of the United States” (Only include this statement if all HDPs in product are official in the current HPUS.)
What is Required on the Principle Display Panel (PDP)?
21 CFR requires certain information to be displayed on the Principle Display Panel (PDP):
- Statement of Identity: The general pharmacological category or main intended action. HPUS Latin names are permitted. This information must be “generally parallel to the base.”
- NDC Number: Can be optionally placed on the PDP, but if placed there, it must be in top third of the panel.
- Alcohol Content (if any)
- Net Quantity of Contents: Weight, in liquid measure or numerical count, must be in bottom third of the PDP, separated from all other printed information. Format and minimum size are strictly defined in 21 CFR. (May add metric units if desired).
- The word “Homeopathic”: Its presence is not specified in CFR, but its absence would be “a failure to reveal a material fact.”
What is Required on the Info Panel for the Traditional Labeling Format?
- Active and Inactive ingredients
- Indication(s)
- Adequate Directions for Use: Must be sufficient so a layperson can use the drug safely and for the purposes intended. In other words, a product’s labeling would be inadequate if it omitted the following:
- Conditions, purposes, or uses for which it is intended.
- Quantity of dose, for each use intended, and usual quantities for persons of different ages and different physical conditions.
- Dosage frequency.
- Duration of treatment.
- Time of administration (in relation to meals, onset of symptoms, other time factors).
- Route of administration.
- Any necessary instructions regarding preparation for use, e.g., shaking, etc.
- Product Specific Warnings, which include Warnings required by official compendia (including the HPUS)
- General Warnings (e.g. pregnancy warning: “As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.”)
- Accidental Ingestion or Overdose Warning (“Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.”)
- Sodium/Calcium/Magnesium/Potassium Warning statements that are required.
- An Alcohol-related Statement depending on the percent of alcohol present. If the drug contains more than five percent alcohol and is labeled for use by adults and children 12 years and older, must state: “Consult a physician for use in children under 12 years of age.” If the drug contains more than 0.5 percentalcohol and is labeled for use by children ages 6 to under 12 years old, must state: “Consult a physician for use in children under 6 years of age.”
- An Adverse Event Reporting mechanism (e.g. “To report SUSPECTED ADVERSE REACTIONS, contact [manufacturer phone and web address] or FDA at 1-800-FDA-1088 or fda.gov/medwatch.”)
There are three additional required statements for which exact placement is not specified:
- A Tamper Evident Statement describing the placement and features of the tamper evident packaging.
- Country of Origin for imported products must be stated (“Product of X” or “Made in Y”).
- The Federal Trade Commission Act (FTC Act) requires objective product claims to be truthful and substantiated. Labelers must decide what is appropriate substantiation, though FTC considers (for drug products) anything less than a randomized controlled trial to be inadequate for drug products. To prevent claims from being misleading, can include additional explanatory information – a disclaimer on labels, labeling, and advertising.
One can use any disclaimer but the disclaimer must be consumer tested to ensure it communicates the additional information effectively and is not deceptive. AAHP’s recommended disclaimer was consumer tested: “Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.” For compliance with FTC, three aspects must be evaluated: 1) the wording of the disclaimer: 2) the placement (which FTC recommends “any disclosure should stand out and be in close proximity to the efficacy message”); and 3) the prominence of the statement in relationship to it’s surroundings.
Details regarding the Drug Facts Labeling format will be covered in a subsequent article.
* Available by subscription at https://www.hpus.com/submitting-monograph/hpus-labeling-guidelines/introduction/