Rethinking FDA’s Food and
Supplement Framework:
Does the Food vs. Supplement Distinction Still Make Sense?
Michael Gruver
Kaye Scholer LLP
July 22, 2014
Topics to Cover
• Background on January 2014 Guidance for Liquid Dietary Supplements
• Impact of the Food vs. Supplement Distinction
• January 2014 Guidance in Detail
• Analysis & Policy Questions
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Introduction
• In January 2014, FDA released a guidance for industry: “Distinguishing
Liquid Dietary Supplements from Beverages.”
– Expanded version of 2009 preliminary guidance.
– Concerned about an “increase in the marketing of liquid products with a wide array of
ingredients and intended uses.”
– Guidance issued to “help dietary supplement and beverage manufacturers and distributors
determine whether a product in liquid form is properly classified as a dietary supplement or
as a beverage.”
– 8 factor test for determining food or supplement.
• Growing sensitivity at FDA regarding beverage products potentially
misbranded as dietary supplements.
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Food vs. Supplement Basics
• Beverages are considered traditional foods under the FDCA.
– “[U]sed for food or drink for man or other animals.” 21 U.S.C. §321(f)(1).
• Dietary supplement contains either specific category of ingredients (e.g.
vitamins) or other “dietary substance for use by man to supplement diet.”
– A product “not represented for use as a conventional food or as a sole item of a meal
or the diet.” 21 U.S.C. §321(ff).
• Beverages serve the basic purposes of the human diet.
– Nutrition, Hydration, and Taste.
• Supplements are a compliment to the nutrition from foods and beverages.
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Importance of the Distinction
• Supplements considered more “drug like’ -- Must include disclaimer saying not intended
to treat, diagnose, or cure disease.
– No supplement may be marketed if it was the subject of a substantial clinical development program aimed at drug approval.
– Manufacturers of supplements must report adverse events.
• Different labeling requirements.
– “Supplement Facts” vs. “Nutrition Facts”
• Treated differently with respect to GRAS criteria.
– Food additives require premarket approval unless GRAS.
– New Dietary Ingredients require NDI notification to FDA, but not required to be GRAS for their intended use in a
supplement (e.g. caffeine).
• Non-dietary ingredients must be approved or GRAS (e.g. binders)
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Overview of New Guidance
• 8 factors determine whether a liquid product can properly claim to be a
beverage or a dietary supplement.
• Answer depends on the overall balance of the factors.
– No guidance as to how factors should be balanced or would be interpreted by the
FDA or a court.
• Market-Drive Approach:
– Heavy focus on how a product is marketed, labeled, or positioned in the marketplace.
– Composition appears a secondary consideration.
– Ask: Is the product advertised as providing some form of nutrition on its own, or does it
merely claim to enhance diet?
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Labeling and Advertising Claims
• Key inquiry is what benefit the product claims to provide.
• Liquid product that claims to “refresh” or “rehydrate” would probably
qualify as a food even if no other nutritional value.
– Can also include visuals (e.g. supplement salad dressing)
• May turn on comparison to other products.
– e.g. “Tastes better than Pepsi or Coke.”
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Representations Outside
of Labeling and Advertising
• Claims made about a product in publicly available
documents other than advertising.
– Patent and Trademark Office
– Securities and Exchange Commission
• Likely far less important in the total calculus of factors than
claims directed at a broader audience.
• Still, relevant (e.g. marketed as a beverage while patented as
a nutritional supplement).
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Product Name
• Factor most easily used to steer a product toward one classification.
• Brand names which use conventional food terms such as “beverage”
“drink” “water” or “soda” represent the product as a beverage.
• FDA attaches great significance to a liquid product’s name.
– “In some instances, the mere use of such a term in a product name or brand name
may be sufficient to establish that the product is represented for use as a
conventional food.” Guidance at p. 3 (January 2014).
• Consider energy “drinks” marketed as supplements.
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Packaging
• Must consider:
–
–
–
–
–
Size
Shape
Color
Volume
Resealable vs. Single-Serving
• Similarity to other types of packaging is also important.
– A liquid product packaged “in a red, 12 ounce pop-top aluminum can
bearing a silver stripe with the name ‘Cola Supplement’ printed on the
can” is likely a beverage. Guidance at p. 3 (January 2014).
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Serving Size and
Recommended Daily Intake
• Relies on survey data that the average American adult consumes 1.2
liters of fluids other than water in a day.
• Liquid products that suggest consumption in amounts approaching 1.2
liters present themselves as beverages.
– Beverages are products intended to constitute the source of that 1.2 liters. (e.g.
“Drink up to three 16-ounce bottles per day.)”
• Liquids that suggest consumption at far lower levels present themselves
as supplements. (e.g. “energy shots”)
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Recommendations and
Directions for Use
• Supplements
– Product should be used in conjunction with conventional food or drink.
• Beverages
– Quench thirst or provide a source of fluids (e.g. water).
– Provide nutritive value (e.g. juice or milk).
– Taste (soda).
• Example: Liquid Vitamin C
– Recommend as a better way to obtain Vitamin C = Supplement.
– Mention that it can rehydrate or tastes good = Beverage.
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Marketing Practices
• Focus on ways of positioning a product in the marketplace, such as
sponsorships, product placement and meta-tagging.
– Social Media Practices: In 2012, FDA issued a warning letter to a drug-maker for
“liking” an unapproved claim on facebook.
• Strong emphasis on whether and how product is compared to
“traditional” forms of beverages or supplements.
– Marketing practices traditionally associated with products in one category?
– Including location of product in stores.
• Broadest factor may be the most confounding.
– Consider new supplement sold in dedicated cooler units.
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Composition
• Lone factor that deals with the actual make-up of the product.
– No clarity as to how it weighs against the other seven factors.
• Undeniable areas of overlap in terms of the ingredients in foods and
supplements.
– FDA maintains that the overlap “is not intended to be total...[it] would strain common sense
to authoriz[e] the creation of a dietary supplement whenever any dietary ingredient is added
to a conventional food.” See Guidance at p. 4 (January 2014).
•
Concern that, without considering composition, manufacturers might attempt
to evade GRAS requirements simply by adding inconsequential dietary
ingredient.
• Mindful that certain dietary ingredients that may lawfully be added to
supplements may not be lawfully added to foods. (e.g. ginko biloba)
– Certain color additives may also be used in supplements but not in foods.
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How You Sell it Matters
More than What You Sell?
• Far more questions than answers:
– What concentration of dietary ingredients in the overall composition of a
product qualifies that product as a supplement?
– Is the relative concentration of dietary ingredients more or less important
than the manner in which dietary ingredients are emphasized in packaging
or marketing?
– If how a product is marketed or advertised outweighs the product’s actual
composition, why consider composition at all?
– Are there products that would qualify as foods or supplements no matter
what their packaging says or how the product is marketed and promoted?
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Not Much Guidance
• Basing guidance in marketing/advertising makes it elastic.
• Factual scenarios that can change quickly.
• Governed by how the product compares to other “traditional” products.
– Package Size
– Labeling
– Placement in Store
• Beverage is one advertising claim or store shelf away from becoming a
supplement, and vice versa.
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Recipe for Confusion
• Limited utility to seeking advice from the FDA prior to introducing or
altering product, packaging, or marketing.
– Business-driven change to any factors might alter balance of FDA analysis.
• In current food/supplement litigation environment a single word or
phrase can give rise to class action claims.
– Accusation that product is “falsely” marketed or sold.
– Little guidance to Courts in determining the merits of those claims.
– Likely to see conflicting rulings based on varying interpretations of the FDA’s stated criteria.
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Does Separate Treatment
Continue to Make Sense?
• “Foods” can become “supplements” based on how they are packaged,
labeled, marketed or placed within a store.
– Questionable benefit to maintaining ephemeral distinction.
• Significant cross-over of ingredients between two classes of product.
– FSMA revising “Nutrition Facts” to increase clarity of information.
– Questionable to maintain separate rules for “Supplement Facts.”
• Wavering distinction brings significant risk for manufacturers.
– Every misapplication of the food/supplement distinction yields a misbranded product.
• Lack of clarity of no benefit to consumers.
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Advantages of Single Standard
• A single uniform standard would give consumers clarity with respect to
the nutritional content of what they purchase or consume.
• Provide suppliers with a clear set of guidelines.
– Based on content as opposed to subjective interpretation of marketing intent.
• Encourages consistent representations in all venues.
• If distinction must be maintained, it should be meaningful.
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Policy Proposals
• Develop a comprehensive and uniform set of guidelines for both foods
and supplements.
– e.g. Single ingredient disclosure scheme.
• If distinction is maintained, should at least:
– Provide distinct definitions to determine whether a product is a food or a supplement..
• Avoid defining products solely in relation to each other.
– Emphasis on concrete factors such as composition or recommended daily intake.
– Require “Fact” panels to provide the same categories of information.
• Facilitate customers’ ability to determine the differences between individual products.
– Reduce emphasis on elastic factors such as marketing strategy or product placement.
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