Rethinking FDA’s Food and Supplement Framework:

Michael GruverKaye Scholer LLPJuly 22, 2014

Does the Food vs. Supplement Distinction Still Make Sense?

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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