The End of Homeopathic Products’ Free Pass

The End of Homeopathic Products’ Free Pass

Homeopathic Products:  What Are They and Why Should You Care?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

Among the unique enforcement actions in fiscal year 2017 are a cluster of warning letters and recalls of homeopathic products.  2017 saw as many warning letters issued to these firms as were issued between 2009 and 2013.  This is a marked change from previous years beginning in 2009 with one warning letter in this category, 2011 had 2 such warning letters, 2012 had 1, 2013 had 2, and 2014 through 2016 had no warning letters issued to homeopathic manufacturers.  But, suddenly, 2017 saw 6 warning letters issued to these firms.  This information is presented in Table 1 below.

In addition, the Federal Trade Commission (FTC) is involved because of labeling issues, and they have cited lack of ‘sound science’ as a problem with these products.  The FDA in partnership with the FTC issued several warning letters in 2011 to manufacturers of homeopathic diet products (HERE, HERE, HERE, HERE, and HERE) based on an evaluation of their website content.

YEAR COMPANY Misbranding or Adulteration COUNTRY
2009 Washington Homeopathic Products Inc Misbranding USA
2011 Standard Homeopathic Co. Inc adulteration and misbranding USA (Los Angeles)
2011 Jenahexal Pharma GmbH adulteration and misbranding Germany
2012 A Nelson and Co. Ltd adulteration and misbranding UK
2013 Standard Homeopathic Co. Inc. misbranding USA (Los Angeles)
2013 Homeolab USA Inc. misbranding Montreal, Canada
2017 Homeolab USA Inc. adulteration Montreal, Canada
2017 Nova Homeopathic Therapeutics Inc. adulteration and misbranding USA
2017 Homeocare Laboratories, Inc. adulteration and misbranding USA
2017 Deserving Health International Corp adulteration BC, Canada
2017 Dae Young Foods Co., Ltd. adulteration and misbranding South Korea
2017 Raritan Pharmaceuticals, Inc adulteration and misbranding USA

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Homeopathic treatments have a century or longer history and are currently marketed as both OTC drugs and prescription drugs.  None of the products, however, have been reviewed and approved by the FDA for safety and efficacy.  These are generally products isolated from ‘natural’ sources rather than being produced by chemical synthesis.  Homeopathic treatment is based on the premise that the dosage of a compound that causes symptom, albeit adverse ones, can be diluted to treat the same symptom.  In general, practitioners believe the greater the dilution, the greater the potency of the resulting homeopathic drug.  The compounds are generally diluted in water, and “Proponents claim that a significantly diluted aqueous solution, consisting mainly of water molecules, retains therapeutic properties due to a “memory” of the substance diluted in it. [1]”  This strains credulity for a regulatory agency that prides itself on science based decision making.

The FDA has ‘governed’ these products under Compliance Policy Guide 400.400 since 1988.  In 2015, with significant growth of this product type and concerns about some of the products safety, the FDA held a public meeting to gather information and feedback from stakeholders.  The FDA reports that they received more than 9,000 comments to a docket soliciting input to their enforcement policies for homeopathic products.  In April 2017, the FDA held a public hearing on a broad range of topics regarding homeopathic products, and the Federal Trade Commission (FTC) held a workshop to evaluate advertising for these OTC products in September 2017.  The FTC FDA published draft guidance for the industry entitledDrug Products Labeled as Homeopathic’ was released for comment in December 2017.  It appears to be the first step in the direction of forming a new foundation for regulation and enforcement of these products.

The FDA guidance describes that these products were historically produced on a patient specific basis by homeopathic physicians, though they are now widely marketed as OTC products.  Consistent with the FDA’s risk based approach to governance and enforcement, the number of individuals potentially exposed to homeopathic treatments is significant and merits the FDA’s attention to update the governance and enforcement of these products consistent with current standards.  The FDA addresses OTC products under the OTC Drug Review by determining that they are “generally recognized as safe and effective” (GRAS/E).  A homeopathic drug is generally considered a ‘new drug’ and, thus, is in need of an NDA (if not determined to be a GRAS/E compound by appropriate experts).  Thus, it seems that most homeopathic products should be considered new drugs and require submission of an NDA that demonstrates safety, efficacy, and consistency of manufacturing.

The FDA has determined that they will take a risk based enforcement strategy for homeopathic products.  The draft guidance states, “The issuance of this guidance, when finalized, is intended to provide notice that any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time.”  This type of product is marketed illegally’ if it is not deemed GRAS/E or is not supported by an ‘approved application.’  This seems to capture most of the products in the category!  The FDA’s revised enforcement policy for these products will take a risk-based approach prioritized for: “…unapproved new drug products that have potential safety risks, lack evidence of effectiveness, are health fraud products, present challenges to the new drug approval or OTC drug monograph systems under the OTC Drug Review, are violative of the FD&C Act in other ways, or that are reformulated to evade an FDA enforcement action.”

The FDA identified the categories of homeopathic products that pose a risk to public health.  These include:

  • Products with Reported Safety Concerns. Information in this category can come from MedWatch reports or other information received by the agency that suggests a potential association of an adverse event with the product.
  • Products that Contain or Purport to Contain Ingredients Associated with Potentially Significant Safety Concerns.  This can include products that may contain potentially infectious agents, controlled substance(s), multiple ingredients that in combination suggest a safety concern, or ingredients that are toxic when minimally diluted or when the manufacturing process is not adequately controlled.  Two recent recalls (one in 2016 and one in 2017) were conducted for homeopathic products that contained inadequately controlled amounts of belladonna, a toxic compound.  These recalls were conducted by Raritan Pharmaceuticals (2016) and Standard Homeopathic Co (2017.)
  • Products for Routes of Administration other than Oral and Topical. For example, this includes ophthalmic products and injectable drugs.
  • Products Intended to be Used for the Prevention or Treatment of Serious and/or Life-threatening Diseases and Conditions.  The FDA is concerned that patients may discontinue proven treatments and opt for treatment with alternative products where there is no evidence of either safety or efficacy.
  • Products for Vulnerable Populations would include those intended for immunocompromised individuals, infants and pediatric populations, geriatric populations, and pregnant women.  The FDA has deemed that these groups may be at greater risk of harm from homeopathic products.
  • Products Deemed Adulterated Under Section 501 of the FD&C Act. This includes products where strength, quality, and potency differs from the standards for a product recognized in the USP, official Homeopathic Pharmacopoeia of the US, NF, or if there are any violations of CGMP (21CFR211).

CONCLUSION:

The FDA will likely receive thousands of comments on their proposed enforcement approach for homeopathic products simply because of the money at stake in sales of these products.  Pharmacy Times reports that retail sales of homeopathic and herbal remedies reached $6.4 billion in 2012…six years ago.  Expect that the guidance will not be finalized quickly, and there will likely be significant pushback from the industry and from those in the government seeking to reduce regulation.  I personally think legal action from the FTC regarding labeling of these products and a lack of a scientific basis for the claims may do more to produce reform in this market segment than the FDA’s limited powers in the area.  There is simply too much money involved to expect voluntary compliance, and these firms will likely resist attempts at additional regulation and enhanced enforcement.  This isn’t a new issue, based on the 2011 warning letters, and actions seem to be moving ever so slowly.

For those who want additional information, the FDA webpage on Homeopathic Products provides a good starting point.  For a more extensive history on the topic, Dr. Suzanne Junod published an article titled ‘An Alternative Perspective:  Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation.

[1] FDA Draft Guidance, ‘Drug Products Labeled as Homeopathic’, December 2017.

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