LightFull Foods - AGEC4433

Transcription

CASE: E-272
DATE: 11/30/07
LIGHTFULL FOODS
One Sunday afternoon in July 2007, Lynn Graham, cofounder and vice president of marketing
for LightFull Foods, a maker of healthy, prepackaged smoothies, went hiking with her dog
Mochi up Mount Tamalpais in Marin County, California. As she climbed, Graham reflected on a
major decision she, the CEO Lara Jackle, and the board had been debating for weeks—whether
to replace stevia,1an herb and key natural ingredient in LightFull’s product, with an artificial
sweetener.
The U.S. Food and Drug Administration (FDA)2 had not approved stevia as a food additive, and
so keeping it in the LightFull formula posed a number of risks. Much-needed partners and
would-be suitors had already shied away from the company because it used stevia. The
alternatives were equally unattractive. Introducing an artificial sweetener into the product meant
more than changing the formula at the manufacturing plant and altering the packaging, labeling
and marketing materials, all of which would be expensive for the start-up. It would also affect
distribution channels—grocery stores and specialty aisles that did not allow products with
artificial ingredients. Those channels were responsible for the majority of LightFull’s revenue.
Beyond business reasons, steering clear of artificial ingredients struck at the heart of what
Graham and Jackle felt was LightFull’s brand essence—being ‘all natural.’ Graham herself did
not eat or drink anything with artificial sweeteners and was proud to have helped build a
company that reflected her values. There were some board members who argued, however, that
the brand was more about health and satiety,3 not really about being all natural, and that most of
1
Stevia is pronounced STEE-vee-uh.
A division of the U.S. Department of Health and Human Services, “the FDA is responsible for protecting the
public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products,
medical devices, (the) nation’s food supply, cosmetics, and products that emit radiation. The FDA (also advances)
the public health by helping to speed innovations that make medicines and foods more effective, safer, and more
affordable; and helping the public get the accurate, science-based information they need to use medicines and foods
to improve their health,” http://www.fda.gov/opacom/morechoices/mission.html (October 15, 2007).
3
Satiety (pronounced sa-TIY-eh-tee) is defined as being full or feeling “gratified to the point of satisfaction,”
http://lightfullfoods.com/scienceofsatiety.php, (August 3, 2007).
Katherine Rudolph Bose prepared this case under the supervision of Professor S. Christian Wheeler as the basis for
class discussion rather than to illustrate either effective or ineffective handling of an administrative situation.
2
Copyright © 2007 by the Board of Trustees of the Leland Stanford Junior University. All rights reserved. To order
copies or request permission to reproduce materials, e-mail the Case Writing Office at: [email protected] or
write: Case Writing Office, Stanford Graduate School of Business, 518 Memorial Way, Stanford University,
Stanford, CA 94305-5015. No part of this publication may be reproduced, stored in a retrieval system, used in a
spreadsheet, or transmitted in any form or by any means –– electronic, mechanical, photocopying, recording, or
otherwise –– without the permission of the Stanford Graduate School of Business.
This document is authorized for use only by Beau Billeaud in Agribusiness Capstone taught by Hinson from January
2010 to May 2010.
LightFull Foods E-272
p. 2
LightFull’s consumers would be neutral about consuming an artificial sweetener. As she
approached the summit of Mount Tam, coaxed Mochi up the hill and turned to take in the views
of the Pacific Ocean, Graham knew that whatever they decided, everything would soon change.
COMPANY HISTORY
Lynn Yako Graham
Graham had attended Stanford University as an undergraduate, where she played on the
women’s varsity softball team. She graduated in 1997 with a degree in economics and went to
work for Mars & Co, a strategy consulting firm, before enrolling at UC Berkeley’s Haas School
of Business in the fall of 2002. Graham was a second-year student at Haas when she began
thinking about what her ideal job would be after graduation. She knew that she wanted to be an
entrepreneur and had been very inspired by one professor in particular, Will Rosenzweig. In
1992, Rosenzweig cofounded Republic of Tea with Mel and Patricia Ziegler, who were also the
cofounders of Banana Republic. Rosenzweig served as the Republic of Tea’s CEO, a successful
$2.5 million4 tea company, which the trio sold in 1994. After that, Rosenzweig was a senior
executive at Odwalla and then cowrote the book The Republic of Tea with the Zieglers. Graham
imagined that her professional life would be close to perfect if she could model it after
Rosenzweig’s—building a company (or two) that provided great quality consumer products and
echoed many of her values, which centered around health and fitness, sports and fun,
environmentalism, travel and cultural curiosity.
Graham’s mother was Japanese and her father American, and though she was born and raised in
the United States, she fully embraced her Japanese heritage. Three months before graduating
from Haas, Graham went to Rosenzweig with a product idea. Graham wanted to introduce the
American public to savory snacks that were popular in Japan, called “onigiri.” Made mostly of
boiled rice,5 onigiri were small and healthy relative to most American snack foods, easy to
manufacture, and could be sold anywhere, including convenience stores. In fact, they were often
found at 7-Eleven stores in Japan, Hawaii, and Japantown in San Francisco. Rosenzweig
thought about it for a minute and told her, “I don’t want to discourage your idea, but I am
working on a business plan for healthy food and beverages⎯would you like to help me write it?”
Graham jumped at the opportunity and went to work for him after graduating from Haas in 2004.
Brand New Brands
Rosenzweig and a long-time colleague Pete Mattson, chairman of Mattson & Company, a
leading food products developer, had an idea to form an incubator for product companies in the
health and wellness space. They did not have specific product concepts in mind but wanted
develop delicious foods that offered real functional health benefits. Rosenzweig, Mattson and
4
Sales were roughly $2.5 million in 1994 and grew to $10 million in 2006.
Source: Stacy Perman, “High Time for Tea in America,” BusinessWeek,
http://www.businessweek.com/innovate/content/mar2006/id20060308_082389.htm?campaign_id=rss_innovate,
March 8, 2006, (August 23, 2007).
5
http://www.shejapan.com/jtyeholder/jtye/living/onigiri/onigiri0.html (August 30, 2007).
2010 to May 2010.
p. 3
Graham formed the original team that generated, researched and tested over 100 ideas before
discarding or advancing the candidates. The ultimate goal was to launch and spin out four
product companies in less than two years. They called the incubator Brand New Brands (BNB).
Lara Jackle
The incubator immediately looked for a chief marketing officer (CMO) to develop and launch
the companies. The founders were introduced to Lara Jackle, who at the time was considering an
offer to work for one of the largest beverage companies in the world on marketing innovation
overseas as well as a leadership position at a national smoothie chain. At 27 years old, Jackle
had joined Balance Bar as the vice president of marketing and helped the company grow from a
start-up to a major natural foods company that Kraft Foods acquired for $268 million. Balance
Bar had achieved a feat that was both difficult and coveted by all start-up brands—that of “niche
to mass” status, starting out in natural foods stores but growing into a successful brand at “club”
stores like Costco and mass merchandisers such as Target. This was the kind of experience that
Brand New Brands companies wanted to replicate. Jackle made a fast decision and joined the
team as CMO with the commitment that she would become the CEO of one of the start-ups.
Going First
LightFull Foods was the first of the four companies to spin out, bolstered by the historic and
forecasted growth of the packaged smoothie and functional beverage markets (Exhibits 1a-d).
Graham and Jackle were passionate about the product and the category, and when it came time
for the company to become a stand-alone entity in May 2006, they went with it.
Being first had its benefits and drawbacks. One advantage was that the company got a lot of
attention from Rosenzweig and the other investors. Everyone wanted the company to succeed,
and the all-star team leveraged its resources, calling on its many contacts to make things happen
for the company that would never have happened for a typical beverage start-up. For example,
Mattson’s food development company was able to offer its services to LightFull at a reduced
rate. Even with all of the help, being the first company to spin out meant paving the way for the
other three start-ups. For example, LightFull courted many investors who became interested.
However, LightFull had to go with the first investors to commit and stop burning incubator
funds. These were typically the faster moving venture investors rather than the strategic food
company investors. As a result, the other BNB spin outs already had warm strategic investor
options (provided by LightFull) when they were ready to raise capital. In addition, the legal fees
alone associated with figuring out the appropriate structure of the spin-out in relation to the
management company, Brand New Brands, cost LightFull about $500,000. The follow-on spinouts would not have to face those challenges, because the template had been forged by LightFull.
Funding
At the time, there were limited institutional sources of early stage capital for food and beverage
companies. Most angel or venture firms were targeting technology and biotechnology
companies, which if successful, traditionally delivered high returns in a short period of time. By
comparison, food and beverage companies often took years to gain a foothold with channel
partners and a following with consumers. Further, once they did gain traction in the market, the
niche LightFull was pursuing was perceived as risky, because although the concept of satiety as a
2010 to May 2010.
p. 4
strategy for weight management had been accepted in the dietician community for decades,
many investors worried that consumer tastes and trends with regard to dieting and eating habits
could change virtually overnight. Many pointed to the Atkins diet, and the vendors that were left
in the lurch when the fad diet lost steam,6 as a reason not to invest in LightFull and Brand New
Brands. Finally, even private equity firms that did invest in food and beverage makers had
minimum investment criteria, which LightFull as a start-up did not yet meet (see Table 1).
Table 1
Category
Financial
Brand
& Customers
Management
Growth & Exit
Criterion
• At least $10 M in revenue and breaking even OR
• A clear path to profitability.
• Ideally $20 M in revenue
• Strong, established brand with clear value proposition to customers
• Established repeat purchase behavior
Experienced management team / CEO with a track record of value
creation
Ability to spin off brands and divisions to strategic buyers
Viable Sources of Capital
Brand New Brands knew it had to look for alternate sources of capital, such as strategic investors
who were looking for a highly targeted fit and had a different investment mandate than did their
PE counterparts—in other words no urgency to do deals. Although the team briefly considered
going out to the angel community, it agreed that finding the right angel within an already
nebulous investor population would be difficult, and there was no guarantee that the angels
would have the level of sophistication and domain expertise the incubator needed. Angels
required as much work as other investors, but typically contributed less money. As Rosenzweig
said, “Raising $1 million is just as costly and time consuming to us as raising $10 million.”
Nevertheless, over the course of six months, Rosenzweig and Mattson’s story about Brand New
Brands coupled with their previous successes interested enough investors that the incubator
attracted a respectable first round. On Valentine’s Day 2005, Brand New Brands announced that
it had raised $15 million in venture investment from Burrill & Company, Great Spirit Ventures,
Unilever Ventures and Prolog Ventures. Following that event, a lot of resources were spent on
the incubator and concept testing over hundreds of concepts. Each of the four spin-outs
ultimately received the equivalent of $1.5 million in seed money and resources. LightFull closed
a follow-on round of funding in August 2006, in which Brand New Brands and a number of
other venture investors participated, bringing the total investment in the company to $8 million.
6
Introduced in the 1970s by Dr. Robert C. Atkins, the diet focused on protein consumption and encouraged the
elimination or drastic reduction of carbohydrates including sugars from fruits and some vegetables. The diet caught
on in popularity starting in the late 1990s but faded by the end of 2004. Retailers, such as General Nutrition Center
(GNC), who had invested heavily in stocking Atkins-branded and other “low carb” products lost millions of dollars
when the diet fell out of favor and they could not sell their inventories.
2010 to May 2010.
p. 5
Many of the investors were drawn to LightFull because of its products’ unique benefits and value
proposition, which spoke to an attractive demographic.7 Therefore, the strategic investors would
pay close attention to any changes to product and company messaging and ingredient mix. Some
adhered to strict standards and values, and therefore saw the need for an all natural formula.
Drawn to different benefits, others would be scared away by the threat of action by the FDA.
ABOUT LIGHTFULL
LightFull positioned its products as smoothies, which came in one size (11 ounces or 325
milliliters) and four flavors: Chocolate Fudge, Café Latte, Peaches & Cream, and Strawberries &
Cream (see Exhibit 2). However, due to the inclusion of stevia extract, the beverages were
officially classified as dietary supplements. Although possible product extensions had been
discussed since the company’s inception, LightFull planned to remain a single product company
well into 2008.
Positioning
LightFull’s product packaging and placement was designed to emphasize several key elements.
First, the convenience of the product as a quick drink for people “on the go” was implied through
its Tetra Pak container8 with straw included, as well as the graphics on the package and location
in the store, often in the refrigeration case next to other single-serving beverages and smoothies.
Second, the smoothie was positioned as a snack and not a meal replacement, a fact highlighted
on the front of the package. Third, the beverage was referred to as a “satiety smoothie,”
emphasizing the drink’s ability to fill up and satisfy the consumer. Fourth, the product claimed
to be all natural, with no artificial ingredients. Fifth, the health benefits were showcased through
the number of grams of fiber and protein per serving listed on the front of the package along with
the product’s inclusion of antioxidants. Sixth, the weight management benefits were
communicated through the message “only 90 calories,” which was proclaimed on the front label
as well as in the supplement information. Finally, information about LightFull being non-fat and
low net carb9 was available, though not underscored, on the packaging (see Exhibit 2).
Consumer description / demographic
LightFull’s target consumers were busy, working women, who were highly educated with
higher-than-average disposable incomes (see Exhibit 3). Many were mothers. The company’s
7
Attractive from an investor’s perspective, (see pp. 5-6 and Exhibit 3).
Tetra Pak is a Swedish company that, among other things, manufactures cartons and employs processes that enable
food liquids to be stored at room temperature for longer periods of time, in some cases up to a year. See Exhibit 2
for an example of Tetra Pak packaging.
9
“Low net carb” refers to the absorption of carbohydrate calories deposited in the body and the resulting elevation
of blood sugar. “Manufacturers subtract the glycerine, sugar alcohols and fiber from the total carbohydrate on the
Nutrition Facts label for ‘Effective Carb Count’ or ‘Net Carbs.’” However, some health experts recommend that
consumers “subtract only the grams of dietary fiber from the total carbohydrate … to calculate a more meaningful
net amount of carbohydrate.” See Robin Edelman, MS, RD, CDE, “Demystifying a New Generation of Diet Foods
and Their Artful Labels,” WebMD, http://www.webmd.com/food-recipes/features/carb-savvy (November 13, 2007).
8
2010 to May 2010.
p. 6
market data indicated that about 90 percent of its customers were dieting either actively or
passively at any given time. Most of LightFull’s customers and prospective customers were
heath oriented, meaning that they exercised regularly and shopped at health food stores, like
Whole Foods, or in the health food aisle at mass grocers, like Safeway. In 2006, Graham’s team
had conducted a survey of customer perceptions and preferences. (Some survey responses are
summarized in Exhibit 4a-g.)
“Juggle Without Struggle”
LightFulls’s top executives, including Graham and CEO Lara Jackle, felt they had an insight into
their core customer base: women who were a lot like them and worked tirelessly at their jobs,
while balancing the demands of family, health, time and finances. The graphic on the front of
the packaging and a personal note from Graham and Jackle on the back (Exhibit 5) spoke to the
concept of LightFull’s aim to help women “juggle without struggle.”
Channels and Sales Process
Although the branding and marketing impacts of keeping stevia in the formula were hotly
debated internally, there was no question that the company’s distribution channels would be
strongly affected by a switch to artificial sweetener. According to Jackle, roughly 40 percent of
sales were coming through Whole Foods and other natural foods stores. The natural food aisles
of regular grocers accounted for the next 35 percent. Online sales, food services and other
miscellaneous accounts made up the remainder of sales during the first year of business.
LightFull had first targeted Whole Foods, Wegmans, and other premium and natural grocery
stores, before it looked to persuade the major grocers to carry the smoothies in their natural food
aisles. The logic was that companies like Whole Foods were market leaders both within the
industry as well as with regard to consumer trust and product adoption. Within a few months,
LightFull saw repeat trials and product sell-outs at individual Whole Foods and Wegmans stores,
giving the start-up greater leverage and enough traction to persuade the chains to carry the
product throughout their hundreds of locations.
Nothing Artificial
Key to LightFull’s entry into Whole Foods and the natural food aisles was that it did not contain
any artificial sweeteners. Whole Foods does not carry products that contain artificial
preservatives, colors, flavors or sweeteners.10 For example, they do not carry Diet Coke, because
it contains Aspartame (see Exhibit 6 for a listing and description of the five FDA-approved
artificial sweeteners). Mass grocers, on the other hand, carry all kinds of products, including
those that contain artificial flavors and colors. However, for a product to be shelved in the
natural food aisle, it cannot contain artificial ingredients.
Being classified as an all-natural product had benefits beyond brand and brand associations to
companies like LightFull. Placement in the natural food aisle also meant avoiding expensive
slotting fees, which could cost $300 per SKU11 per store. In other words, if LightFull were to
10
Whole Foods’ quality standards: http://www.wholefoodsmarket.com/stores/southstreet/donation.pdf (October 31,
2007).
11
Stock Keeping Unit (SKU).
2010 to May 2010.
p. 7
change stevia to Splenda, for example, the company could be asked to pay up to $300 in slotting
fees multiplied by four products, times the number of Safeway stores (approximately 1,750), or
roughly $2.1 million in a one-time fee. Many start-ups were able to avoid these fees by proving
their merit to large grocers, a process which was time-consuming and somewhat arbitrary
depending whether the start-up was able to establish relationship with the individual buyer.
There were added complications though, as Graham pointed out:
We could pay that slotting fee, but there is no guarantee that the buyer would not
decide to yank us two months later. The dance vendors do with buyers is really
tricky, especially in our business. First, we have to identify which buyer to engage
with—is it natural foods, grab-and-go beverage, yogurt, or someone else? Even
after we do that, we then have to roll the dice, just like every other company, and
hope that the grocer likes us and wants to keep our product on the shelves.
The cost of raw materials would actually be helped by a switch, however, because artificial
sweeteners were cheap and plentiful. The cost of stevia was $33.18 per pound or $.073 per
gram. However, the wholesale cost of artificial sweeteners, such as Splenda or Equal, ranged
from only $.01 to $.045 per gram. The result of changing the product’s formula and operations
at the manufacturing facility would be a one-time but expensive charge of $300,000. New
product testing and trial were included in that cost but foregone sales were not, as Jackle
explained:
If we reformulated the product, we knew that we would not be able to grow into
new distribution channels during that time of changeover. Vendors would not
want to deal with being sold on one product and then having to swap it out a few
months later for a potentially different sized, shaped, colored and manufactured
new product. We’d have to wait and forfeit untold revenues until the new product
was ready. And in this business, it always takes twice as long and three times
more than you forecast.
Growth & Key Metrics
By the end of 2006, LightFull had grown its distribution
2007, that number had grown by an additional 50 percent.
success in retail, especially grocery where many items
LightFull smoothies had a relatively long shelf-life of
between four and ten inventory turns per week per flavor.
from zero to 1,100 stores. By midInventory turn was a key measure of
are highly perishable. Even though
nine months, the product averaged
Each LightFull smoothie retailed at a price point between $1.99 and $2.79. The company sold its
products wholesale to distributors at a cost of $1.25 per unit. Management had a gross margin
goal of 40 percent by the end of the fourth year. At their current 11-ounce package size,
however, that goal had eluded them. They were not able to realistically project a clear path to 40
percent margin with their current pricing and cost of goods assumptions. The company aimed to
be cash-flow neutral in year 3.
2010 to May 2010.
p. 8
COMPETITION
Even though smoothie stands and retail chains like Jamba Juice were in LightFull’s product
category, the start-up narrowed the competitive field to consumer packaged goods (CPG)
companies that sold through a channel, such as grocery stores or online (e.g., Amazon.com). (See
Exhibit 7 for a side-by-side comparison of the competitive landscape.)
Prepackaged Smoothies and Yogurt Drinks
Various companies produced yogurt beverages or smoothies⎯from huge corporations like
Dannon, which had several brands in the category,12 to relatively small companies like
Stonyfield Farm. LightFull saw Stonyfield as its closest competitor in terms of product,
positioning, ingredients and philosophy. Stonyfield did not use preservatives or artificial flavors,
colors and sweeteners. Beyond professing all natural ingredients, Stonyfield also could claim to
be organic. Among its suite of dairy products, Stonyfield produced smoothies that included the
sweetener erythritol. According to Stonyfield, “erythritol is an all-natural, no-calorie alternative
to sugar.”13 The ingredient was formally classified as a sugar alcohol that exhibited 70 percent of
the sweetness of sugar but with a zero glycemic index, because it had no effect on blood sugar
levels. Found in low levels in various fruits and higher levels in fermented products like wine,
erythritol had been recently approved for use in the U.S. and Canada. The erythritol that
Stonyfield used was made from a base of sugar, which was mixed with water and fermented with
a natural culture. Erythritol alone, however, did not achieve the flavor and level of sweetness
that pleased consumers’ tastes. Therefore, Stonyfield paired erythritol with naturally milled
sugar, which increased the number of grams of sugar, and therefore the calorie count, quite a bit
for its 10-ounce smoothie (Exhibit 8).
Also in this category was Odwalla, a successful maker of juices, smoothies and natural food bars.
Odwalla was acquired by Coca-Cola in 2001 for $181 million.14 Although Odwalla’s smoothies
generally contained several times the number of calories that a LightFull smoothie had, it also
claimed all natural ingredients and had a widely recognized and respected brand name.
Weight Management Products
Many of LightFull’s target customers were concerned with weight management, and therefore
the company saw products from Slim-Fast and Weight Watchers as competition. Slim Fast had a
range of drinks that served various functions, including: meal replacement, appetite suppressant,
protein supplement, low carbohydrate and easy to digest (lactose and gluten free). Weight
Watchers had a line of smoothies with very similar selling points as LightFull’s—many were low
calorie (80 calories each), had zero fat, and contained a few grams of fiber (2 grams each).
12
Dannon’s yogurt drink brands included: DanActive, Danimals, Frusion, and Light & Fit,
http://dannon.com/ourproducts.aspx (August 20, 2007).
13
Stonyfield Farm website, http://stonyfieldfarm.com/OurProducts/erythritol.cfm (October 15, 2007).
14
Dave Marino-Nachison, “Coke Swallows Odwalla,” Fool.com, October 30, 2001,
http://www.fool.com/news/foolplate/2001/foolplate011030.htm (October 5, 2007).
2010 to May 2010.
p. 9
Snack and Energy Bars
Because LightFull had positioned itself in the snack category, it also had non-beverage snacks to
contend with. Even though LightFull had further defined itself as a healthy snack, the category
was still crowded. Graham thought that snack and energy bars like PowerBar’s Pria and LUNA
Bar also posed a threat to LightFull’s market share. A division of Clif Bar, where Graham
interned between her first and second years of business school, LUNA was created to target
women and women’s unique health needs and product requests. LUNA bars were sweetened
with organic brown rice syrup and organic evaporated cane juice15 (Exhibit 9).
Generic Healthy Snack Foods
Although they posed less of a direct threat to the start-up, the general category of healthy snack
foods, like apples, rice cakes and traditional servings of yogurt, was still on LightFull’s radar.
STEVIA
Given all of the alternative sweeteners used by the competition, Graham and Jackle revisited the
use of stevia in LightFull. They had thoughtfully chosen the herb even before the company spun
out from Brand New Brands, because stevia had many advantages, and an expert in the field had
predicted that FDA approval was “imminent within months.” Months turned into years, however,
and the challenges involved with using the supplement in their smoothies remained. Some of the
biggest setbacks came in November 2006. A major strategic investor and potential
manufacturing and distribution partner pulled out of a deal with LightFull “at the eleventh hour”
after having done more background research on stevia. To add insult to injury, that same month,
a new Whole Foods region backed out of a distribution agreement upon learning that the
smoothies contained stevia, even though the smoothies were already in distribution at other
Whole Foods locations. Jackle recalled, “Lynn and I were disgusted, because we knew that the
root of the fear for these potential partners boiled down to a government policy issue—possibly
one heavily influenced by lobbyists—and not a health issue.”
What is Stevia?
Stevia is derived from the leaves of the stevia plant or herb, which is native to Paraguay. The
stevia leaf has either a green or brownish color and is used whole or chopped, dried or fresh.
Stevia extract is referred to as stevioside, which comes packed as a light white powder,16 similar
to powdered sugar. Stevia has been used as a sweetener and flavor enhancer for hundreds of
years all over the world. In addition to Paraguay, at the time of Graham’s hike in Marin County,
stevia was grown and approved for use in Japan, China, Germany, Malaysia, Israel and South
Korea. According to Graham, “stevia is used in over 40 percent of all sweetened goods in Japan,
one of the countries with the strictest food ingredient standards in the world. Aspartame, for
15
http://lunabar.com/products/FAQs.cfm?documentid=2&location=1,1#artificial (August 20, 2007).
Stevia – Stevioside Information Center, http://www.stevia-stevioside.com/purchasing_stevioside.php (August 20,
2007).
16
2010 to May 2010.
p. 10
example, is not a legal food additive in Japan.” With zero calories and 300 times the sweetness
of sugar, the herb was extremely attractive to LightFull and other companies.
The Controversy
In the late 1980s an anonymous interest filed a trade complaint against stevia with the FDA. At
the time of the complaint, Celestial Seasonings Herbal Tea Company was one of a handful of
companies in the United States using stevia as a sweetener in its products. The FDA ordered
Celestial Seasonings to stop producing teas made with stevia, claiming the teas were
"adulterated,” and ultimately banned stevia in 1991. The government agency moderated its
stance on the herb under the Dietary Supplement Health and Education Act of 1994 (DSHEA),17
which was passed by Congress and allowed stevia, along with many other products, to be sold as
a nutritional supplement, but neither as a food additive nor as a sweetener.
Definition of a Dietary Supplement18
Under DSHEA, a dietary supplement is defined as “a product that is ingested, is intended to
supplement the diet and, among other requirements, contains a ‘dietary ingredient,’ [which] may
include vitamins, minerals, herbs or other botanicals, amino acids, and dietary substances such as
enzymes [as well as] metabolites, constituents, extracts, concentrates, or combinations of these
ingredients.”19 Dietary supplements could be packaged in various forms including tablets,
capsules, liquids and bars. The FDA enforced what the Congressional act mandated⎯that a
supplement be labeled as a dietary supplement and that information on the product’s label “must
not represent it as a conventional food or a sole item of a meal or diet.”20
Further, because dietary supplements are regulated as foods, not drugs, the FDA does not require
evaluation and approval of a product before it is sold on the open market, “unless specific
disease prevention or treatment claims are made.”21 However, the FDA does have the authority
to remove or demand removal of those dietary supplements that it concludes are unsafe. Also,
because there may be considerable variation between batches of dietary supplements, as a result
of not being formally reviewed for manufacturing consistency, the FDA maintains that it is
nearly impossible “to guarantee that ingredients identified on product labels are present in the
specified amounts or present at all [in the product itself].”22
Claims
According to the FDA, claims that could be used on the labels of food and dietary supplements
fell into three categories: health claims, nutrient content claims, and structure/function claims.
17
See Exhibit 10 for the provisions provided under DSHEA.
This section heavily references the FDA’s Dietary Supplement Enforcement Report,
http://www.fda.gov/oc/nutritioninitiative/report.html, December 18, 2002, (August 23, 2007).
19
Ibid.
20
Ibid.
21
“Selected Vegetables/Sun's Soup (PDQ®): Health Professional Version,” National Cancer Institute,
http://www.cancer.gov/cancertopics/pdq/cam/vegetables-sun-soup/HealthProfessional/page2/print, December 19,
2006, (August 23, 2007).
22
Ibid.
18
2010 to May 2010.
p. 11
“The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA,
or, in the case of advertising, with the Federal Trade Commission.”23 (See Exhibit 11 for more
details on each kind of claim.) Because LightFull was not claiming that stevia performed a
specific health benefit, the second and third categories (nutrient content and structure/function
claims) were most relevant to the company’s use of stevia.
Listing the nutrient content, or supplement content in LightFull’s case, was straightforward. The
product was labeled a “dietary supplement” on the front of the package, and 66 mg of stevia was
listed among the ingredients. According to Graham, “The inclusion of stevia and stevia alone
mandated that we call ourselves a dietary supplement. Any claims we made about the product,
therefore, had to fall under the rules that governed dietary supplements.”
For conventional foods, structure/function and health claims needed to focus on “effects derived
from nutritive value.”24 However, for dietary supplements, including stevia, structure/function
claims “may focus on nutritive as well as non-nutritive effects.” Some companies had made
structure/function claims in lieu of health claims in order to avoid FDA approval requirements.
Under DSHEA's provisions, dietary supplement makers could include “truthful and nonmisleading claims that describe the role of a nutrient (or supplement) in supporting wellness,”25
on their product labels. Examples of approved claims included “calcium builds strong bones”
and “antioxidants protect against cell damage.” These claims were referred to as
structure/function claims or nutritional support claims. The manufacturers needed to furnish
proof for their claims and notify the FDA within 30 days of first marketing the supplement.26
The agency reserved the right to interpret the line between structure/function claims and health
claims in the same or similar way for conventional foods as it did for dietary supplements.
However, the FDA did not require conventional food manufacturers to notify the agency about
their respective structure/function claims.
Even though LightFull classified its smoothies as nutritional supplements, there was precedent
suggesting the FDA could demand that the company reclassify the products as food items instead
of supplements and then issue a “cease and desist” order, given the inclusion of stevia. One
example of such precedent was a line of soups containing herbs such as St. John’s Wort and
Echinacea made by The Hain Food Group, Inc. in the late 1990s. The products were labeled as
supplements and contained structure/function claims normally found on dietary-supplement
labels. By labeling the canned soups as supplements, the FDA felt that the company “sought to
escape its obligation to obtain an FDA food additive approval or demonstrate to the FDA that
Echinacea and St. John’s Wort are GRAS [‘generally recognized as safe,’ an FDA classification]
when used as food ingredients … as well as be able to make structure/function claims even
23
CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements, “Claims That Can Be Made for
Conventional Foods and Dietary Supplements,” September 2003, http://www.cfsan.fda.gov/~dms/hclaims.html
(August 23, 2007).
24
FDA, Center for Food Safety and Applied Nutrition (CFSAN), http://www.cfsan.fda.gov/~dms/labstruc.html
(August 23, 2007).
25
Source: Coalition to Preserve DSHEA, http://dshea.org/key_provisions.html (August 23, 2007).
26
FDA, Center for Food Safety and Applied Nutrition (CFSAN), http://www.cfsan.fda.gov/~dms/labstruc.html
(August 23, 2007).
2010 to May 2010.
p. 12
though these herbs do not provide taste, aroma, or nutritive value.”27 The FDA instructed the
company to reclassify and re-label its products as soups. As one FDA spokeswoman said, “If it
walks like a duck and talks like a duck, it’s probably a duck, or in this case, a soup.”28
Even if the FDA itself did not scrutinize LightFull, there was still the risk that competitors could
make a claim against the start-up either through FDA channels or by filing a lawsuit. Consumer
or special-interest groups were other threats. The negative press that would follow could squash
the start-up. Just the idea that any of the above scenarios could happen had already been enough
to scare off would-be LightFull partners and acquirers. Acquisition was the only true exit for the
company given that initial public offerings in the food and beverage space, particularly for a
company so small, were virtually unheard of.
Why the Ban on Stevia?
Although not many scientific studies had been conducted on stevia, in 1999 European scientists29
concluded that high doses of stevioside given to male rats for 22 months produced problems with
the male reproductive organ system, including reduced sperm production and symptoms leading
to an increased risk of infertility.30 A similar experiment was conducted on female hamsters,
which were fed large amounts of a derivative of stevioside called steviol. The test results
showed that the female hamsters had fewer and smaller offspring.31 It was unknown if small
amounts of stevia could cause reproductive problems in rats, hamsters or humans. However,
there were also question marks around stevia potentially promoting cancer by causing mutations
in the cell’s DNA as well as interfering with energy metabolism, especially in children. Neither
of the above concerns had been verified, but they were concerning to some toxicologists.32
Despite stevia’s widespread use in other countries and the subsequent lack of any stevia-related
health concerns overseas, toxicoligists were worried that Americans consumed products in far
greater amounts than did the Japanese, for example. Because stevia had the potential to replace
sugar and artificial sweeteners in all kinds of products, especially weight management and,
conversely, indulgence products like ice cream, cookies and the like, the FDA feared mass
consumption of stevia could be right around the corner. One toxicologist commented, “In the
U.S., we like to go to extremes. So a significant number of people here might consume much
greater amounts [of stevia].”33
27
Michael F Jacobson, Bruce Silverglade, and Ilene R Heller, “Functional Foods: Public Health Boon or 21st
Century Quackery?”, Center for Science in the Public Interest,
http://www.cspinet.org/reports/functional_foods/usa_market.html, 1999, (August 30, 2007).
28
Primary interview, June 2007.
29
The Scientific Committee on Food for the European Commission (Source: David Schardt, “Stevia: A Bittersweet
Tale,” Nutrition Action Healthletter, http://cspinet.org/nah/4_00/stevia.html (August 21, 2007)).
30
Ibid.
31
Ibid.
32
Toxicology is the study of the adverse effects of chemicals on living organisms. Toxicologists study symptoms,
mechanisms, treatments and detection of poisoning, especially the poisoning of people. (Source: dictionary.com,
August 21, 2007.)
33
David Schardt, “Stevia: A Bittersweet Tale,” Nutrition Action Healthletter, cspinet.org/nah/4_00/stevia.html,
(August 21, 2007).
2010 to May 2010.
p. 13
Coca-Cola and Cargill Announcement
Apparently a few large national food and beverage makers were as attracted to stevia as their
foreign counterparts, because in 2005 Coca-Cola and Cargill, a privately held American
agricultural company that owned the rights to produce erythritol, inked an agreement to codevelop a zero-calorie sweetener using stevia.34 In May 2007, the companies filed more than 20
patent applications surrounding the process of producing the sweetener, which they were calling
Rebiana. The agreement would give Coke exclusive rights to beverages produced with the
sweetener and Cargill the same exclusivity with regard to foods.
Although Coke and Cargill planned to spend a lot of resources on Rebiana, analysts and reporters
pointed out that the companies would still need to lobby Congress to approve the use of stevia.35
It took almost two decades for the FDA to approve the use of Sucralose (brand name Splenda) in
the U.S.36 Once Splenda was launched in 1999 though, it quickly became the best-selling
artificial sweetener in the country, with sales of “$212 million in 2006 in the U.S. [the world's
biggest market].”37 Equal, the second most popular artificial sweetener, sold $48.7 million.
In considering how an approved Rebiana might impact LightFull, Graham was pessimistic:
Cargill is motivated to push this forward, because neither stevia nor erythritol
alone is very effective. Erythritol isn’t sweet enough, and stevia has a licorice
aftertaste. The magic is in blending the two. Also, Cargill is the sole producer of
erythritol, so if stevia were GRAS, that would put them in the enviable position of
having the only all-natural, zero calorie sweetener that tastes good. However,
Cargill needed a partner to help drive approval through the FDA and to educate
consumers. What better partner than Coca-Cola? That said, their plans with Coke
will kill our ability to use stevia, because their partnership agreement would give
Coke exclusive use of the only GRAS-certified stevia for use in beverages.
COMPANY IN CRISIS
The board was divided when the question arose: “Is LightFull about being healthy or natural, or
both?” Graham recalled that, “We had already put a stake in the ground that we were about
satiety, but what else were we? Could we be filling, low calorie and all natural and still be
credible?” The team wondered if the triumvirate of benefits would be too confusing for one
brand, particularly a new one. Graham and Jackle had reviewed all of the consumer data and
research with the board, spoken to every expert in the field and now had to make a decision,
which would surely impact fundraising, sales strategy, and the future viability of the company.
In view of so many conflicting issues, what should they do?
34
Matt McKinney, “Cargill, Coca-Cola team up on new sweetener,” May 31, 2007,
www.startribune.com/535/story/1217968.html (August 30, 2007).
35
Congress could be lobbied, but not the FDA, per primary interviews with an FDA spokeswoman (June 2007).
36
Robin Pagnamenta, “Coca-Cola unveils new challenge to Tate & Lyle's Splenda,” The Times, June 1, 2007
(August 23, 2007).
37
Ibid.
2010 to May 2010.
p. 14
Exhibit 138
Historical and Forecasted Sales of Smoothies and Functional Beverages
1a. Total U.S. Sales of Packaged Smoothies (2001-2006)
1b. Total Forecasted U.S. Sales of All Smoothies (2007-2011)
38
Source: Mintel
2010 to May 2010.
p. 15
Exhibit 1 (continued)
1c. Total U.S. Sales of Functional Smoothies and Yogurt Drinks (2002-2007)
1d. Total Forecasted U.S. Sales of Functional Beverages (2007-2012)
2010 to May 2010.
p. 16
Exhibit 2
LightFull Product Graphic and Nutritional Information
(Peaches & Cream)
2010 to May 2010.
p. 17
Exhibit 3
LightFull Survey Respondent Demographics
Number of Respondents
Gender
Age
Ethnic make up
Income
Employment
Education Level
Children
State of Residence
333
99% female
• 39%: 30-39
• 44%: 40-50
• 13%: 51-59
• 83% White
• 2% African American
• 7% Asian
• 6% Hispanic
• 1% American Indian
• 2% Other
• 65% dual income
• 23%: $65 k to 89.9 k /yr
• 55%: $90 k to150 k /yr
• 18%: over $150 k / yr
• 70% Full time
• 14% Part time
• 11% Stay at home mother
• 6% Not working at present
• 62% 4 year college
• 28% Master’s Degree
• 9% Doctorate
• 1% 2 year college
• 48% No children in home
• 12% Child under age 2
• 22% Child age 2-5
• 24% Child age 6-12
• 15% Child age 13-18
• 41% California
• 24% Texas
• 14% Colorado
• 8% Washington
• 6% Arizona
2010 to May 2010.
p. 18
Exhibit 4
Select LightFull Survey Questions and Results39
4a. How often would you drink this product?
4b. Given the price of this product, how would you rate the value?
4c. How new and different do you find this product?
39
Of note, the survey was conducted before the product name (spelling), pricing, and packaging were finalized.
2010 to May 2010.
p. 19
4d. Which of the following statements best describes you? (Weight management)
4e. Which of the following statements best describes you? (Artificial sweeteners)
4f. How important is each of the following attributes? (The top number in each cell is the
count of respondents who selected the option. The bottom number is the percent of the total
respondents who selected the option.)
2010 to May 2010.
p. 20
4g. Where would you expect to buy this product?
2010 to May 2010.
p. 21
Exhibit 5
Juggle Without Struggle™
(As seen on the back of the LightFull smoothie package)
A message from Lara and Lynn, cofounders of LightFull Foods …
“All our lives we’ve struggled to stay healthy while juggling work, family and
friends, community, and just plain fun.
Too often, eating right was the ball that got dropped. We longed for a convenient
snack that was truly satisfying, low calorie, and all natural. That’s what inspired
LightFull Satiety Smoothie.
LightFull satisfies our sweet tooth (no small task!) with only 90-100 calories. And
with 6 grams of both fiber and protein, it keeps us feeling full and satisfied for
hours. Best of all, LightFull is 100 percent natural.”
2010 to May 2010.
p. 22
Exhibit 6
FDA-approved Artificial Sweeteners40
40
Debra Manzella, R.N., “Artificial Sweetener Reference Chart,” About.com,
http://diabetes.about.com/od/nutrition/a/sugarsubchart.htm (August 23, 2007).
2010 to May 2010.
p. 23
Exhibit 7
Key Competitive Metrics41
Product
Vol/unit Cal/unit All Natural
(Sweetener)
LightFull
11 oz
90
Yes
(Erythritol & stevia)
Stonyfield
10 oz
130
Yes
“Peach Light Smoothie”
(Erythritol & naturally
milled organic sugar)
Slim Fast
11 oz
180
No
“Optima Creamy Milk
(But uses natural
Chocolate Ready To
sweeteners: sugar and
Drink Shake”
fructose)
Dannon
7 oz
80
No
“Light ‘n Fit”
(Splenda)
Strawberry Banana
Smoothie
Odwalla
15.2 oz
380
Yes
“Super Protein”
(fruit juice)
Luna Bar
1.7 oz
180
Yes
“Chocolate Peppermint (48 gm)
(Organic brown rice
Stick”
syrup & organic
evaporated cane sugar)
Apple (med.)
5.5 oz
80
Yes
(fructose)
McDonald’s
7.5 oz
540
No
“Big Mac”
(214 g)
41
42
Showcased
Ingredients
Fiber, protein,
antioxidants
Calcium, protein, fiber,
active cultures
Healthy
Filling Retail price
(subjective)
Yes
Yes
$1.99-2.69
Yes
Yes
$1.89-2.29
24 vitamins
and minerals
No
Yes
$1.31-$1.42
No fiber or
significant vitamins
and minerals
Yes
No
$0.95-1.05
Protein, vitamins,
amino acids
Fiber, protein,
antioxidants
Yes
Yes
$2.50-3.69
Yes
Yes
$0.99-1.75
Avg. 3 gm fiber
Yes
No
$.50 - $1 ea
Two all-beef patties,
special sauce,
lettuce, cheese,
pickles, onions on
a sesame seed bun.
No
Yes
$3.4142
All product prices based on those listed online or in major grocery stores as of October 9, 2007.
Price as of July 2007, http://www.oanda.com/products/bigmac/bigmac.shtml (October 5, 2007).
2010 to May 2010.
Exhibit 8
Stonyfield Organic Peach Smoothie Ingredient and Nutritional Information
2010 to May 2010.
p. 24
p. 25
Exhibit 9
Luna Bar “Chocolate Peppermint Stick”
Nutritional Information and Ingredients
Ingredients: LunaPro (Cocoa Soy Rice Crisp [Soy Protein Isolate, Organic Rice Flour, Alkalized Cocoa],
Organic Toasted Oats, Organic Roasted Soybeans, Organic Soy Flour, Organic Flaxmeal), Organic
Brown Rice Syrup, Organic Coating (Organic Evaporated Cane Juice, Organic Palm Kernel Oil, Organic
Soy Flour, Organic Soy Lecithin, Organic Vanilla), Organic Chocolate Cookies (Organic Oat Flour,
Organic Evaporated Cane Juice, Sunflower Oil, Cocoa, Unsweetened Chocolate, Salt, Baking Soda, Soy
Lecithin), Vegetable Glycerin, Inulin (Chicory Extract), Organic Cocoa, Organic Unsweetened
Chocolate, Organic Sunflower Oil, Peppermint Candy (Evaporated Cane Juice, Peppermint Oil, Colored
with Red Cabbage), Natural Flavors, Sea Salt, Green Tea Extract. Vitamins and Minerals: Dicalcium
Phosphate, Magnesium Oxide, Calcium Carbonate, Ascorbic Acid (Vit. C), Tocopherol Acetate (Vit. E),
Niacinamide (Vit. B3), Ferrous Fumarate (Iron), Zinc Oxide, Molybdenum Glycinate, Calcium
Pantothenate, Pyridoxine (Vit. B6), Riboflavin (Vit. B2), Beta Carotene (Vit. A), Thiamin (Vit. B1),
Manganese Sulfate, Selenium AAC, Cupric Oxide, Chromium AAC, Cyanocobalamin (Vit. B12), Folic
Acid, Biotin, Phytonadione (Vit. K), Potassium Iodide Allergen statement: Contains soy. May contain
traces of dairy, peanuts & tree nuts. No hydrogenated oils
* “[Luna Bar] sources ingredients that are not made using wheat or dairy and are not genetically
engineered.”
2010 to May 2010.
p. 26
Exhibit 10
Key Provisions of DSHEA43
Definition
DSHEA defines a dietary supplement as any product that contains one or more dietary ingredients, such
as vitamins, minerals, herbs or other botanicals, amino acids or other ingredients used to supplement the
diet. Dietary supplement ingredients may not be regulated as food additives or drugs.
Safety
The legislation maintains the U.S. Food and Drug Administration's (FDA) authority to safeguard the
public against any unsafe product. A dietary supplement can immediately be removed from the market if
the FDA believes that it presents a public health hazard.
New Products
Before marketing a new dietary ingredient, a manufacturer must supply the FDA adequate safety
information at least 75 days before marketing. A "new dietary ingredient" is one that is first marketed
after October 15, 1994.
Structure/Function Claims
Under DSHEA's provisions, dietary supplement makers may include on product labels truthful and nonmisleading claims that describe the role of a nutrient in supporting wellness. (Examples of truthful claims
include: calcium builds strong bones; antioxidants protect against cell damage.) These claims are referred
to as structure/function claims or nutritional support claims. Manufacturers must have proof for these
claims and notify the FDA within 30 days of first marketing the supplement.
Consumer Education
Articles from scientific journals or other publications may be distributed by dietary supplement sellers as
long as they are not false or misleading, do not promote a specific brand, present a balanced view of the
scientific evidence and are displayed separately from dietary supplements.
Labeling
A dietary supplement label must list the name and quantity of each active ingredient; identify the product
as a dietary supplement; and for herbal supplements, identify the part of the plant from which it is taken.
Nutrition labeling must be presented in a format appropriate to the product.
Good Manufacturing Practices (GMPs)
Under DSHEA, supplements must comply with current good manufacturing practices. The FDA is
authorized to issue special regulations on GMPs for dietary supplements, modeled after food GMPs.
Office of Dietary Supplements
DSHEA's passage established an office within the National Institutes of Health to coordinate research on
dietary supplements and disease prevention, develop a database of supplement research, and advise the
Secretary of Health and Human Services on supplement regulation, safety and health claims.
43
Source: Coalition to Preserve DSHEA, http://dshea.org/key_provisions.html (August 23, 2007).
2010 to May 2010.
p. 27
Exhibit 11
Claims That Can Be Made for Conventional Foods and Dietary Supplements44
(Abridged)
I. Health Claims
Health claims describe a relationship between a food, food component, or dietary supplement ingredient,
and reducing risk of a disease or health-related condition. A "health claim" by definition has two essential
components: (1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or
health-related condition. For example, a product could state, "diets high in calcium may reduce the risk of
osteoporosis", provided the claims meet certain criteria and are authorized by an FDA regulation.
II. Nutrient Content Claims
Nutrient content claims describe the level of a nutrient or dietary substance in the product, using terms
such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using
terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that
does not "characterize" the nutrient level may be used to describe any amount of a nutrient present.
However, a statement such as "only 200 mg of sodium" characterizes the level of sodium as being low
and would therefore need to conform to the criteria of an appropriate nutrient content claim or carry a
disclosure statement that it does not comply with the claim. Most nutrient content claim regulations apply
only to those nutrients or dietary substances that have an established daily value. The requirements that
govern the use of nutrient content claims help ensure that descriptive terms (e.g., high, low) are used
consistently for all types of food products and are thus meaningful to consumers. Healthy has been
defined by a regulation as an implied nutrient content claim that characterizes a food that has "healthy"
levels of total fat, saturated fat, cholesterol and sodium. Percentage claims for dietary supplements are
another category of nutrient content claims and are used to describe a percentage level of a dietary
ingredient for which there is no established Daily Value. Examples include simple percentage statements
such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice
the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)."
III. Structure/Function Claims
Structure/function claims have historically appeared on the labels of conventional foods and dietary
supplements as well as drugs. However, DSHEA established some special regulatory procedures for such
claims for dietary supplement labels. Structure/function claims describe the role of a nutrient or dietary
ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong
bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to
maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants
maintain cell integrity," or they may describe general well-being from consumption of a nutrient or
dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency
disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in
the United States. The manufacturer is responsible for ensuring the accuracy and truthfulness of these
claims. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has
not evaluated the claim and that the dietary supplement product is not intended to "diagnose, treat, cure or
prevent any disease," because only a drug can legally make such a claim. Manufacturers of dietary
supplements that make structure/function claims on labels or in labeling must submit a notification to
FDA no later than 30 days after marketing the dietary supplement that includes the text of the
structure/function claim.
44
U.S. Food and Drug Administration, the full version of this document was issued on March 20, 2001 and revised
October 2001 and September 2003. http://www.cfsan.fda.gov/~dms/hclaims.html (October 9, 2007).
2010 to May 2010.

LightFull Foods - AGEC4433

Transcription

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