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When Do Consumer Products
Become Medicine?
by Jessica Santos, Ph.D.
June 2015
www.kantarhealth.com
When Do Consumer Products Become Medicine?
As an increasing number of consumer products such as cosmetics and
healthy foods claim to have medical benefits, the boundary between
fast-moving consumer goods (FMCG) and medicines or medical devices
is blurring. Complicating matters further, the U.S. Food and Drug
Administration (FDA), the European Medicines Agency (EMA), and the
European Commission (EC) offer different opinions on key questions.
For example, the FDA classifies the electric toothbrush as a medical
device because it is intended to prevent tooth decay.1 However, the EC
says it’s not a medical device because it is for hygiene purposes and is a
modification of the conventional toothbrush.2
Ambiguity raises
tremendous
challenges
for healthcare
Getting the Classification
Right
Ambiguity such as this raises tremendous
challenges for healthcare researchers, who
often work with products for which they have
yet to fully commit to a classification.
Researchers are often faced with a host of
critical questions, such as:
researchers, who
• Which guideline and legislation should we
use?
often work with
• Which association or competent authority
should we notify?
products for which
they have yet to
fully commit to a
classification.
• Is product testing allowed, and if so, how?
What’s more, testing food and testing drugs
are completely different ballgames. While
supermarkets regularly offer food-tasting stalls
without consumer screening, the thought of
pharmacies providing antibiotics or leukemia
drugs for testing is simply absurd.
Nonetheless, key considerations for consumer
products with medicinal benefits include:
• W
ill adverse-events reporting procedures
change along with the classification?
• H
ow is the product used to treat “inbetweeners,” e.g., a facial moisturizer that
calms eczema? Should participants take a
certain degree of risk, as for most FMCGs;
or should the sponsor ultimately control and
manage risk, as in clinical trials?
Manufacturers need to understand the exact
classification of their products for research
and development, testing, production and
marketing. That means understanding that
consumer attitudes toward consumer and
medical products are completely different in
terms of potential risk, usage and consumption.
Healthcare researchers must understand
the product classification position to properly
design a study – from recruitment and
execution, to publication within the correct
regulatory framework.
What Are Medicines and
Medical Devices?
A medicine, or drug, is a chemical substance
or therapeutic agent that has known biological
effects on humans or other animals and is
used in the prevention, diagnosis, alleviation,
treatment or cure of disease.3 Foods are
generally excluded from this definition, despite
their physiological effects on animal species.
A medical device is medical technology
used in the diagnosis, prevention, monitoring,
treatment or alleviation of disease or disability.
Interestingly, a medical device does not
achieve its primary effect by pharmacological,
immunological or metabolic means.4
Medicines and medical devices are classified
in a very detailed way.5 For medicines, the
classifications can range from an over-thecounter (OTC) cold remedy that contains
mainly Vitamin C to chemotherapy drugs. For
medical devices, the range varies greatly as
When Do Consumer Products Become Medicine?
well, from walking sticks to pacemakers and
implants.
Because of these broad definitions, once a
product claims a medical benefit it may be
classified as a medical product. This has led to
many debates, with discussions often centered
on the medicinal benefits of herbal medicines,
food supplements and cosmetics. Additionally,
well-publicized U.S. debate continues on
whether marijuana is a healing herb or a
dangerous drug.6
Regulating Medicinal and
Consumer Products
To alleviate
confusion in the
marketplace,
regulatory bodies
around the world
are developing
guidelines and
updating existing
ones to better
classify products.
To alleviate confusion in the marketplace,
regulatory bodies around the world are
developing guidelines and updating existing
ones to better classify products, but these
efforts are in progress and will take time to
complete. Nonetheless, enormous variation
exists by country, region and how a product is
marketed.
In the United States, the FDA governs the
safety and efficacy of medical products,
foods, tobacco and cosmetics, including OTC
and prescription drugs. In Europe, the EMA
regulates only medicine, while medical devices
are CE marked by manufacturers themselves,
inspected by EU notified bodies, and audited
by each country’s competent authority, such
as the Medicines and Healthcare products
Regulatory Agency (MHRA) in the UK. Food
and cosmetics are regulated by food standard
agencies7 and European Cosmetic Products
Regulation (EU Regulation 1223/2009).
Herbal medicine is no longer an unregulated
territory, as it is now included in the scope
of the FDA and EC. FDA lists supplement
products as brand herbal remedies.8 The EC’s
Directorate General for Health and Consumer
Policy (DG SANCO) provided guidance
through the publication of the Herbal Directive
2004/24/EC9 on the registration of traditional
herbal medicinal products. With herbal
substances classified for use in both medicinal
products and food,10 the debate in Europe will
continue on whether cannabis is a healing herb
or dangerous drug.6,11
A product’s medical benefits or ability to
prevent, diagnose, alleviate, treat or cure
a disease is key to determining whether a
product is a medicinal product or a consumer
product. It’s noteworthy that some directives12
only becomes active when a product is
commercialized and marketed beyond own
usage. For example, when a homemade
medicine, medical device or cosmetic is
used by someone other than the inventor or
inventor’s entity.
A Checklist – What
Researchers Should Do
1.Know your product – It sounds obvious,
but you need to research product labeling,
classification and dossiers submitted
to competent authorities, as these are
often not included in the project brief. If a
product is seeking additional labeling (e.g.,
e-cigarettes may claim to have smoking
cessation benefits, hence making them
a medical device13,14), recognize that
information from the public domain may be
outdated or not be sufficient.
2.Know your clients – Manufacturers are
interested in exploring the benefits of their
products, especially medical ones, which
means huge marketing potential. Know the
intentions of your clients. Do they seek
additional benefits of an existing product?
Are they encouraged by recent real-world
research? Do they seek regulatory approval
on another drug or food classification? Such
questions are often raised in the boardroom
and may not be communicated explicitly to
researchers.
3.Know your market – A product that
is classified as a food in one country
could well be classified as a medicine
or a medical device in another, see
aforementioned example of electric
toothbrush. Regulatory bodies and
competent authorities by country or region
have their own approval agenda and
procedure. Never enter a new market or
test a new group of participants without
sufficient consultation to understand how
the product is perceived in that market.
When Do Consumer Products Become Medicine?
4.Know your customers – Whether the
research design is an intensive clinical trial,
real-world research or consumer-based
opinion research, you need to know and
understand customer impressions of your
product. For example, Dutch citizens have
a more relaxed view on cannabis, while
people in some countries can purchase
antibiotics OTC.
While overlap, gray areas and classification
changes of medical and consumer products
may seem endless, astute observations in this
space can lead to educated research decisions
that deliver optimum commercialization results.
Information by Drug Class. U.S. Food and Drug
Administration website. http://www.fda.gov/Drugs/
DrugSafety/InformationbyDrugClass/default.htm
5
Gilman V. The Majirjuana Debate: Healing
Herb or Dangerous Drug? National Geographic
News. http://news.nationalgeographic.com/
news/2005/06/0621_050621_marijuana.html
6
Food Standards Agency website. http://www.food.
gov.uk/
7
List of Supplement Products from Brand Herbal
Remedies. U.S. Food and Drug Administration
website. http://www.accessdata.fda.gov/scripts/
h1n1flu/brand_list.cfm?brand=Herbal%20%20
Remedies&cat=Supplement
8
Directive 2004/24/ED of the European Parliament
and of the Coucil of 31 March 2004. Official Journal
of the European Union. http://eur-lex.europa.eu/
LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:
0090:en:PDF
9
Q&A: Registration of Traditional Herbal Medicinal
Products. http://ec.europa.eu/dgs/health_consumer/
docs/traditional_herbal_medicinal_products_en.pdf
10
References
Cohen MH. FDA regulates electric toothbrushes
as medical devices. Complementary & Alternative
Medicine Law Blog. http://www.camlawblog.com/
articles/new-regulation/fda-regulates-electrictoothbrushes-as-medical-devices/
1
Medical Devices directive. Conformance CE
Marking & Product Safety. http://www.conformance.
co.uk/adirectives/doku.php?id=medical
2
http://www.drugs.com/dict/drug.html; http://www.
merriam-webster.com/; http://www.fda.gov/; http://
www.ema.europa.eu/
3
http://www.drugs.com/dict/drug.html; http://www.
merriam-webster.com/; http://www.fda.gov/; http://
www.ema.europa.eu/; https://www.gov.uk/medicinesmedical-devices-blood/medical-devices-regulationsafety
4
510(k) Substantial Equivalence Determination
Decision Summary. http://www.accessdata.fda.gov/
cdrh_docs/reviews/k143599.pdf
11
Active implantable medical devices. European
Commission website. http://ec.europa.eu/growth/
single-market/european-standards/harmonisedstandards/implantable-medical-devices/index_
en.htm; http://eur-lex.europa.eu/legal-content/en/
ALL/?uri=CELEX:32007L0047; http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
default.htm
12
Electronic Cigarettes (e-Cigarettes). U.S. Food and
Drug Administration. http://www.fda.gov/NewsEvents/
PublicHealthFocus/ucm172906.htm
13
Gornall J. Electronic cigarettes: medical device or
consumer product? BMJ. 2012;345:e6417. http://
www.bmj.com/content/345/bmj.e6417
14
When Do Consumer Products Become Medicine?
For more information,
please visit
www.kantarhealth.com.
About Kantar Health
About the Author
Kantar Health is a leading global healthcare
consulting firm and trusted advisor to many of
the world’s leading pharmaceutical, biotech and
medical device and diagnostic companies. It
combines evidence-based research capabilities
with deep scientific, therapeutic and clinical
knowledge, commercial development knowhow, and brand and marketing expertise to
help clients evaluate opportunities, launch
products and maintain brand and market
leadership.
Jessica Santos, Ph.D.
Kantar Health deeply understands the
influence of patients, payers and physicians,
especially as they relate to the performance
and payment of medicines and the delivery of
healthcare services. Our advisory services,
built on a solid foundation of market research
and data, span three areas critical to bringing
new medicines and pharmaceutical products
to market – commercial development, clinical
strategies and marketing effectiveness.
Kantar Health operates in more than
40 countries and employs more than
600 healthcare industry specialists and
practitioners, including a high number of
medical doctors, epidemiologists, PhDs,
PharmDs and pharmacists, and biologists,
biochemists and biophysicists. We work
across the product lifecycle, from preclinical
development to launch, and are experts
at bringing multiple stakeholders together
to advance the commercialization of
pharmaceutical products. Our team acts as
catalysts to successful decision making in
the life sciences industry, helping our clients
prioritize their product development and
portfolio activities, differentiate their brands
and drive product success post-launch. Kantar
Health is part of Kantar, the data investment
management division of WPP.
If you would like us to act as catalysts for you,
contact us at www.kantarhealth.com/contactus.
Dr. Jessica Santos is the Global Compliance
Director in Kantar Health, the largest custom
market research company focused on the life
sciences industry. She is primarily responsible
for providing oversight and support across the
40+ Kantar Health global offices in the areas
of regulation, interaction with clients, suppliers
and others within Kantar Health, Kantar and
WPP. Dr. Santos is responsible for maintaining,
anticipating and coordinating all activities with
regard to compliance laws/regulations, industry
guidelines, pharamcovigilance and client
contracts, defining and driving the execution
of Kantar Health’s Quality Strategy – our
approach to measuring and improving our
quality efforts.
Dr. Santos is an experienced statistician,
analyst, methodologist and market research
scientist. She gained her reputation through
her publications and professional committee
work in the industry. She is a frequent speaker
and contributor in major conferences and has
a Ph.D. in Marketing, an MRS fellowship and
Chartered Marketer status.
Dr. Santos is a member of UK Research Ethics
Committee, EphMRA, BHBIA and PMRG
Government Affairs Committee, reviewer and
co-chair of ISPOR, and MRS Professional
Development Advisory Board and Examiner.