You Can`t Afford to Be Flagged for Non-Compliance

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Charting New Marketing Strategies for 2013 and Beyond!
Steady Growth Despite Economic
Factors
• The U.S. Natural Product industry grew from $30 billion
in 2011 to $32 billion in 2012 (steady 7% growth)
• In 2012, dietary supplements alone accounted for $11.5
billion in sales
• Growing Categories: Omega-3s; Joint Health; Eye
Health; Digestive Health (esp. Probiotics)
(Sources: Nutrition Business Journal
and Nutritional Supplements in the U.S. report issued by Packaged Facts)
Steady Growth Despite Economic
Factors
In 2012, more than two thirds of all American adults (68%)
said they use nutritional or dietary supplements.
Self-described “Regular” Supplement Users by Age Bracket:
(as opposed to “Seasonal” or “Occasional”)
• Ages 18-34 – 57%
• Ages 35-54 – 71%
• Ages 55-plus – 76%
(Source: Survey by the Council for Responsible Nutrition)
Steady Growth Despite Economic
Factors
Economic factors, rather than thwarting growth, may be
helping to fuel it…
• Consumers are looking for less-costly alternatives to
medical bills. Preventive health is an investment!
• They’re also watching the Dr. Oz Show and taking action
on his tips. (We’ve all witnessed the rollercoaster in
product availability after he promotes a supplement.)
Getting Products to Market:
Compliance Affects Everything!
Before you decide to enter or expand in this market,
you need to know:
• How to leverage brands in a compliant fashion
• Differentiation and Positioning—product niche,
formulation/application, compliant USPs and
consumers’ felt needs
• Distribution strategies that address compliance
challenges
Getting Products to Market:
Compliance Affects Everything!
Before you decide to enter or expand in this market,
you need to know:
• Marketing strategy (and budget) that is compliant but
effective—including synergistic partnerships (piggyback
visibility)
• Intellectual property issues—protecting compliant
names and taglines!
You cannot afford to be flagged for
non-compliance!
Warning First, Cost Second
Cost to revise and re-print all material
Compliance from the start saves:
• Time
• Money
• Reputation
You cannot afford to be flagged for
non-compliance!
“Our print materials and our ads are
compliant. So, we’re set, right?”
You cannot afford to be flagged for
non-compliance!
Not necessarily.
Have you looked at your:
• Website
• Facebook and other social media platforms
• Customer testimonials
• Retailer/Employee education materials (you can be a
little more open here, but still NO disease claims)
• Product manufacturers’ level of compliance (both
packaging text and quality standards)
FDA Warning Letters – Recent Trends
Highlights from a 3-week period in February
Warning letters sent to drug and supplement companies:
(Excluding warnings to food manufacturers and medical devices)
• 41% went to pharmaceutical companies; most were
regarding unapproved generic versions of Tamiflu
• 59% went to dietary supplement companies
 Half of these were related to cGMP violations
 The other half were related to non-compliant cold and flu
claims
FDA Warning Letters – Recent Trends
Major Target: Cold & Flu Prevention
Intro paragraph in a form letter to several companies:
“This is to advise you that the United States Food and Drug Administration
("FDA") and the United States Federal Trade Commission ("FTC")
reviewed your website … in January, 2013. The FDA has determined that
your website offers products for sale that are intended to diagnose,
mitigate prevent, treat or cure the Flu Virus in people. These products
have not been approved or cleared by FDA for use in the diagnosis,
mitigation, prevention, treatment, or cure of the Flu Virus.”
All the letters in this category involved the FDA and FTC
citing websites for non-compliant cold/flu claims.
FDA Warning Letters – Recent Trends
Major Target: Cold & Flu Prevention
Non-compliant disease claims that were flagged:
• Powerful cold and flu defense
• Taken at the first sign of a cold or flu symptom
• Taken throughout the cold season as an effective
preventative
• Available in the Cough & Cold Section
• Boost your immune system and fight cold and flu
• Single most powerful formula to help guard your health
• Most effective alternative to the flu shot
FDA Warning Letters – Recent Trends
Major Target: Cold & Flu Prevention
Study Summaries and “historic uses” are often non-compliant:
• Resveratrol has been studied as an antiviral, inhibiting
certain flu and respiratory viruses taken at the first sign
of a cold or flu symptom
• Garlic is used historically in treating flu
• 14 different clinical trials of Echinacea use found that
taking the supplement helped people get over cold and
flu symptoms a day and a half earlier
FDA Warning Letters – Recent Trends
Major Target: Cold & Flu Prevention
DSHEA applies to Facebook, Twitter, testimonials and press releases.
All of the following resulted in FDA warning letters:
•
•
•
Tweet: “Get your #flu vaccine and keep (PRODUCT) handy to
prevent the flu this season.”
Testimonial: “I’ve been using (PRODUCT) for 9 months and feel like
I’ve dodged everything coughed, breathed or recycled at me, even
through a rough germ-filled winter.”
News Wire Headline: “Strong Flu Season Grips the Nation, Leaving
Americans Scrambling to Protect their Families.” (The FDA stated that
this headline “demonstrates the intended use of your product.”)
FDA Warning Letters – Recent Trends
Lessons Learned
• When it comes to immune health, the only compliant
claim is: Supports a healthy immune system
• The FDA and FTC are teaming up on reviews
• The same keywords that drive customers to your site,
may drive an FDA or FTC inspector to your site as well
• Even study-supported description of an ingredient’s
“history of use” can be flagged if it involves reference
to ANY disease state
FDA Warning Letters – Recent Trends
Lessons Learned
• Both manufacturers and online stores have been cited
• No, it’s not as common, but retailers do get FDA warning
letters, especially when their materials and websites:
 Recommend products for specific diseases/conditions
 Give overt medical advice
 Tout specific natural products as alternatives to FDAapproved pharmaceuticals
• Retailers are legally required to abide by DSHEA
(Source: “Roadmap for Retailers” report by CRN)
FDA Warning Letters – Recent Trends
Major Target: cGMP Compliance
Regulatory Pressure Directed at the Products You Offer
From warning letters addressing quality assurance:
• You failed to prepare and follow a written Master Manufacturing
Record (MMR) for each unique formulation
• You failed to establish product specifications for the identity, purity,
strength, and composition for each dietary supplement you
manufacture
• Your MMRs failed to include actions necessary to ensure quality,
such as mixing/blending instructions, times, and equipment, and
acceptable capsule weight range
FDA Warning Letters – Recent Trends
Major Target: cGMP Compliance
Regulatory Pressure Directed at the Products You Offer
From warning letters addressing personnel violations:
• You failed to identify any employee(s) responsible for quality
control
• You failed to make and keep documentation of training,
including the date of the training, the type of the training, and
the person(s) trained
FDA Warning Letters – Recent Trends
Major Target: cGMP Compliance
Regulatory Pressure Directed at the Products You Offer
The devil is in the details!
• Your laboratory does not follow the USP Microbial Limits Method
for Total Plate Count and Yeast and Molds
• The initials of the person responsible for weighing or measuring…
was not documented
• You rely on certificates of analysis (COA) from the suppliers…but
you failed to qualify the suppliers by establishing the reliability of
the suppliers’ COA
• You did not have written procedures for calibrating, inspecting, and
checking your digital weighing scale or mechanical blender
FDA Warning Letters – Recent Trends
Lessons Learned
• If you manufacture your own brand, your entire
management team must understand and implement
cGMPs. Do NOT cut corners.
• Make sure your contract manufacturer is following cGMPs
with comprehensive documentation. A manufacturer with
OTC and pharma-grade standards is best.
• “Small” companies are not immune to inspections. All of
the cGMP violation warnings we reviewed were for
companies with low brand awareness.
FDA Warning Letters – Recent Trends
Lessons Learned
Retail-only entities are affected, too:
• Specific brands and products can be temporarily
unavailable while a company remedies compliance
violations.
So..
• Diversify your brand offerings in each category.
• Research your offerings and focus on brands with a solid
record in compliance and quality.
FDA Warning Letters – Recent Trends
See for yourself…
http://www.fda.gov/ICECI/EnforcementActions/WarningLett
ers/default.htm
A Quick Compliance Review
Terms to avoid:
• Heals, cures, relieves
• All diseases and conditions
Terms to use:
• Promotes/Supports healthy ______ .
Hire an agency with copywriters experienced in
writing compliant text
Run all consumer literature, labels, web copy past
your attorney BEFORE publishing
There’s an Art to This
Use Special Caution in Hot-Button Areas
• Immune Support
• Inflammation
• Heart Health
• Weight Management
• Blood Glucose Levels
• Children’s Products
• Dermal Health and Topicals (yes, the FDA monitors these)
There’s an Art to This
Sample Verbiage
For example…
Communicating a product’s anti-inflammatory properties
• Absolutely NO: soothing, reducing, pain-relieving, or
anti-inflammatory effects
• Safe: “Supports healthy range of motion.”
• Moderate Risk: “Promotes a healthy, balanced
inflammation cycle.”
There’s an Art to This
Know Your Reader
Are you marketing toward a physician?
Then “Supports leukocyte health and function” might be helpful
in communicating your non-compliant “wound healing” claim.
Are you marketing toward a consumer?
You might need to use “Supports the skin’s healthy
rejuvenation”
An example of how distribution strategies can address compliance challenges!
There’s an Art to This
Before and After
Non-compliant: “Rids the body of harmful toxins”
Revision – Consumer: “Supports the body’s ability to detoxify
itself”
Revision – Retailer Staff Education: “Supports liver health and
function” (Paired with “For Retailer Education ONLY. Not for
Consumer Distribution.)
Reworking the Non-Compliant Claim
BOTH the Claim & Educational Text are Non-compliant:
“Successfully addresses magnesium deficiency”
“Magnesium deficiency can lead to life-threatening health
conditions”
Revision:
“Helps maintain healthy magnesium levels in the body”
“The body provides lots of hints when it is running low on
magnesium.”
Reworking the Non-Compliant Claim
Non-Compliant Claim
Compliant Revisions
Promotes fast recovery from athletic
injuries
Promotes athletic recovery*
Reduces stress and makes you feel calm
Supports the body’s balanced response
to stress*
Reduces blood pressure
Supports healthy blood pressure levels
already in the normal range*
Improves blood circulation to the brain
Supports healthy microcirculation/promotes healthy circulation
to the brain*
Reworking the Non-Compliant Claim
Non-Compliant Claim
Compliant Revisions
Lifts your mood and reduces lethargy
Promotes balanced mood and healthy
energy levels*
Soothes food allergies
Promotes healthy digestive function*
Reduces blood pressure
Supports healthy blood pressure levels
already in the normal range*
Improve focus and restore memory
Promote focus and helps support
healthy mental acuity*
Prevents insomnia
Promotes healthy, restful sleep*
Get over your cold faster
Support a healthy immune system
during times of seasonal challenge*
Reworking the Non-Compliant Claim
The “good source”— a regulation
favorite!
“A good source of electrolytes”
(compliant only if a serving contains at least 10% of the RDI)
“An excellent source of potassium”
(compliant only if a serving contains at least 20% of the RDI)
Revision:
“Provides trace amounts of key electrolytes.”
So, You’re Getting Ready to Launch
A Compliance Checklist
• cGMP manufacturing
• New Dietary Ingredient (NDI) filing
• Substantiation Files
• Awareness of AERs & SAERs
• DSHEA compliant materials – supporting all of the
above!
Launch Prep
Ask Your Manufacturer About
• Integrated QA systems from raw ingredient to final
product
• Raw ingredient quarantine & verification
• Batch testing
• Final product testing
• Prop 65 (in California, The Safe Drinking Water and
Toxic Enforcement Act of 1986)
 All process documentation provided
 If they’re not opening their books to you, walk away. You can be liable for their
mistakes.
Launch Prep
 Your manufacturer is solid, and your marketing materials are
compliant.
 You’re getting ready to file NDI paperwork (if needed) and
Substantiation Files.
Are all your claims science-supported?
Support for Claims
Compliant “healthy function” claims still require
scientific support
• Efficacy & Safety
• Human Clinicals – ideally the gold standard
(double-blind, placebo-controlled, at least 100
participants)
To say, “This proprietary blend supports healthy blood glucose levels already
within the normal range,” you may need scientific support of your blend having
efficacy in diabetic models.
Support for Claims
We have to have scientific proof of curative value, but
we still can only make the “healthy function” claim?
Support for Claims
If we’re totally compliant, we can’t say ANYTHING
about all those scientific studies!
That’s not fair!
Working Within the DSHEA Framework
Take a deep breath…remember what life was like
before DSHEA
The great extremes:
• The FDA considered requiring “Food Additive” filing for
supplements
• There were shutdowns of vitamin companies
• Meanwhile, there were some truly dangerous products
on the shelves
Working Within the DSHEA Framework
 DSHEA’s implementation may not be perfect, but it gave us a
framework.
Let’s look at how to operate within that framework.
Working Within the DSHEA Framework
 Balancing product safety and advertising honesty
with
 The freedom to market health-changing products without
intensive food additive or pharmaceutical-grade testing
Working Within the DSHEA Framework
 Product Differentiation
PLUS
 Compliant Consumer Education
Working Within the DSHEA Framework
Compliance + Educational Strategy
• Pair compliant marketing materials (packaging,
brochures, advertising, web copy, testimonials—yes, all
of it!)
WITH
• Authoritative third-party literature that drives
customers to your product
Solution #1: Third-Party Literature
• Your company can’t be so forthright about your
product(s), but a doctor or well-known industry
professional can author literature that covers all the
details.
• Have your story told without saying a word.
Solution #1: Third-Party Literature
Effective 3rd-party: includes unique terms and phrases identical
to your brand’s compliant identifiers—especially when they
don’t mention your brand by name (i.e. – a multi-strain probiotic,
helper minerals for bone health, timed-release magnesium,
polysaccharide-enhanced Aloe Vera, etc…)
• At the store—this makes your brand stand out when
the consumer reads labels
• Online—this results in immediate highly-qualified hits
Remember, it’s credible third party
literature only if…
• The author is a health care provider, preferably an MD
(the business owner CANNOT be the author)
• Several products are mentioned (other than your
brand; may be in complementary niches though)
• There is a solid reference list to back the author’s
claims
Solution #2: Leveraging Publicity to
Educate Consumers
Advertising
• Bought
• Guaranteed
• Consistent
• It’s you talking about you (self-promotional)
• Often ignored
Publicity
• Can’t buy
• Not guaranteed
• Inconsistent
• BUT, it’s others talking about you (endorsement)
• Attention-getting
Solution #2: Leveraging Publicity to
Educate Consumers
Publicity = Trust & Credibility
Publicity is third party validation from highly trusted, unbiased
sources—news reporters.
Trust & Credibility = Consumer Response
• Publicity placements lead to an immediate consumer
response better than any other form of marketing buy
• Vital for new businesses
Solution #2: Leveraging Publicity to
Educate Consumers
Secrets of getting good publicity:
• Properly prepare and present your information
• Designate a spokesperson - charismatic, interesting, can
tell your story well
• Target buyers - order your products
• Target consumers - drive them to your distribution
channels
Solution #3: Leveraging the Internet for
Consumer Education
• U.S. online consumers spent an estimated $226 billion
in 2012—up from $202 billion in 2011 and $165 billion
in 2010 (Source: Forrester Research Inc. as cited by Internet Retailer)
• Total internet sales in the natural products industry
grew 13% in 2010 (Source: NBJ)
• Double digit growth is expected to continue over the
next several years
• Increased availability of health and nutrition info online
is likely to drive even more web sales
• Websites must be designed to be “friendly” to both
people and search engines
Solution #3: Leveraging the Internet for
Consumer Education
People are Searching Online for Your Products
• In the U.S., 86% of people say search engines are the
most efficient way to find info about products
• 70% of people use the Internet for information before
making online purchases
• 63% of Internet users worldwide use the web to
research a product or service before buying
(Source:
eMarketer survey)
• 80% of individuals aged 32-44 buy products on the
Internet (Source: Pew Internet & American Life Project)
Solution #3: Leveraging the Internet for
Consumer Education
But it takes a Savvy SEO
• Meta tag text and keywords need to be compliant, too
• Let third party endorsers do the bragging—they need
to mention BOTH aggressive claims AND your compliant
keywords, phrases, and claims for this to really work
• Remember the 2-click requirement!
Put it All Together:
Integrated Marketing Communications
(IMC)
“Use all of them”
with unified, compliant, educational messaging
 Core Strategies
• Public Relations
• Internet Tools
 Supporting Methods
• Print
• Radio
• TV
• Advertising
• Trade Shows
Educate Yourself at Industry Websites
• http://www.crnusa.org/
 (CRN – Council for Responsible Nutrition)
• http://www.npainfo.org/
 (NPA – Natural Products Association)
And consult a knowledgeable attorney regarding any
immediate decisions in your company
Charting New Marketing Strategies for 2013 and Beyond!
“You have to believe in yourself.”
-Sun Tzu
Charting New Marketing Strategies for 2013 and Beyond!
Thank You!
The IMC team wishes you
all the best in your ventures.
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