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INGREDIENTS TO WATCH FIBER’S FUTURE HEART HEALTH
Ten to Bet On, p. 38 The Promise of Inulin, p. 44 Beating High Blood Pressure, p. 48
January/February 2013
Vol. 16, No. 1
What’s In
Tomorrow’s
Energy Drink?
Ingredients to court the health-conscious consumer, p. 26
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INGREDIENTS TO WATCH FIBER’S FUTURE HEART HEALTH
NUTRITIONAL OUTLOOK • JANUARY/FEBRUARY 2013
Ten to Bet On, p. 38 The Promise of Inulin, p. 44 Beating High Blood Pressure, p. 48
January/February 2013
Vol. 16, No. 1
What’s In
Tomorrow’s
BEVERAGES • FIBER • HEART HEALTH
Energy Drink?
Ingredients to court the health-conscious consumer, p. 26
VOLUME 16, ISSUE 1 • NUTRITIONALOUTLOOK.COM
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JANUARY/FEBRUARY 2013
VOLUME 16, ISSUE 1
69
48
75
FEATURES
26 Beverages
The energy drink market is a hot mess. Let’s sort it out.
38 Ingredients to Watch
A bird’s-eye view of 2013’s promising health ingredients
44 Fiber
Want a versatile fiber? Check out inulin.
On the Cover:
Photo by www.istockphoto.com/avesun 48 Cardiovascular Health
How coffee and chocolate extracts are lowering
blood pressure
56 Contract Manufacturing
Our Q&A with contract manufacturers about the “do it all”
business model
4 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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9LVLW%RRWK
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JANUARY/FEBRUARY 2013
DEPARTMENTS ONLINE CONTENT
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Proposed standards for Nutritional Outlook.
fish oil; Foods vulnerable
to fraud
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14 Company News
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GRAS; Natoli partners
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16 Global Regulations Flax Oil for Inflammation Truvia Certified for Carbon
As bureau director David www.NutritionalOutlook.com/ Footprint
Vladeck exits the FTC, will news/flax-oil-inflammation www.NutritionalOutlook.com/news/
his mission endure to bring truvia-becomes-first-stevia-sweetener-
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20 Global Regulations
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Nutritional Outlook
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8 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
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PAGE
Should We Label Caffeine
Content?
Barely a week goes by without some me-
More energy drink and energy supplement compa-
dia headline about energy drinks. In recent nies may begin voluntarily disclosing cafeine amounts,
months, coverage—particularly on caffeine however. In light of negative press on cafeine and energy
drinks, companies may prefer to be exceedingly forth-
products—reached fever pitch. (Turn to our right with customers about what their products contain.
timeline on page 28 for a closer look.) On the industry’s side, one leading association encour-
ages its own members to label cafeine content. As part
Te underlying concern is whether energy drinks— of its code of ethics, the American Herbal Products As-
as well as energy supplements—are used safely. Worries sociation (AHPA; Silver Spring, MD) recommends that
include the potential danger of combining cafeine and product labels not only disclose the presence of added
alcohol, as well as consumption by minors. cafeine in a dietary supplement but also disclose the
Tese days, scrutiny has shifted to yet another aspect “quantity of cafeine per recommended serving, stated in
of energy products: how/whether products are labeled to both (1) milligrams per serving and (2) in equivalent ap-
disclose cafeine content. proximate cups of cofee, where 100 mg of cafeine repre-
Under current food and dietary supplement rules, en- sents one cup of cofee.”
ergy drinks and energy supplements must disclose the According to AHPA president Michael McGufn, the
presence of added cafeine by listing cafeine as an ingre- goal is to give consumers as much information as pos-
dient. (“Added” cafeine is considered diferently than caf- sible. “Many consumers beneft from cafeine-containing
feine contributed naturally to a formula by, say, botanical products. Tey are most informed to make their pur-
ingredients—such as guarana or yerba mate—inherently chase decisions when they know [how much] cafeine is
containing cafeine.) present in the products they use,” he says.
In the case of both energy drinks and energy supple- Tere’s another reason why companies may choose to
ments, however, disclosing the precise quantity of caf- list cafeine levels, adds Justin Prochnow, attorney and
feine is optional. Dietary supplements, for instance, do shareholder at Greenberg Traurig LLP (Denver). “I’ve
not need to list a specifc cafeine amount if the cafeine talked to a lot of people who feel it’s a beneft to disclose
is considered part of the company’s proprietary ingredi- the amount of cafeine, specifcally because if customers
ent blend. are looking for a good cafeine boost, they’ll know the
All energy drinks and supplements should be re- product has the amount they want,” he says.
quired to disclose their cafeine amounts, argue those “I think it’s a beneft both ways,” Prochnow contin-
worried that some products contain unsafe, high caf- ues. “I do think that more disclosure of cafeine content
feine levels. would help people make more informed decisions about
Also of concern is whether companies that do choose how much cafeine they actually want from a product.
to list cafeine levels do so accurately. In recent months, For instance, if they know a product contains 180 mg
Consumer Reports—as well as NSF International, Har- of cafeine, and they know they will be drinking two of
vard Medical School, and the Uniformed Services them, for a total of 360 mg, then maybe they’ll say, ‘Tat’s
University—reported that a number of products they enough for me.’”
tested contained higher levels of cafeine than the lev-
els listed on their product labels, sometimes exceeding Jennifer Grebow
20% the levels listed. Editor-in-Chief
10 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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glucose of 24.3%, and an average reduction in serum insulin
of 28.2% when faced with a 70 gram sucrose challenge.
All-natural powder with Chromax®
Ideal for use in supplements, foods,
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Supported by multiple studies
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or call 1-800-526-0609; 201-246-1000 (outside the U.S.).
*According to the New York City Department of Health
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Groups Submit Comments on
Proposed Codex Standard for
Fish Oil
January 15 was the deadline to submit com- vetted nor confrmed by any third-party en-
ments on a fnalized draft of the Codex Ali- tity. In fact, fatty acid profle might not be supplement industry know that this has big
mentarius Commission’s proposed standards the best tool for confrming a fsh’s species possibilities to inhibit innovation in the fu-
for fsh oil. Members of the project’s electron- because fatty acid profles can fuctuate due ture,” MacKay says. For instance, he explains,
ic working group, including the Council for to such factors as a fshery’s geographic lo- if industry invents new, better preservatives
Responsible Nutrition (CRN; Washington, cation, food sources, and environmental and for fsh oil in fve years, those preservatives ei-
DC), shared their comments. seasonal conditions, says Douglas MacKay, ther would not meet Codex standards if they
If successful, this standard will be the frst ND, CRN’s vice president of scientifc and are not on the list, or Codex would need to go
Codex Alimentarius standard created for regulatory afairs. “If anchovies typically through the arduous process of adding them
fsh oils. Te proposed standard applies to have 18% EPA present, but global warming to the standard.
oil from fsh—as well as from marine sources causes their EPA levels to eventually fall to CRN, as well as other commenters such as
shellfsh and krill—used in food and food 12%, according to the table, can we still call the Federation of European Specialty Food
supplements. them anchovies?” he asks. Ingredients Industries (ELC; Brussels), point-
Next, the Codex Committee on Fats and Another argument is that sections of the ed out other problem areas as well, related to
Oils (CCFO), which oversees the project, will draft listing appropriate processing methods which food additives are allowed in fsh oil,
discuss the proposed draft to determine next are restrictive because they may not account as well as oxidation parameters for favored
steps at its meeting coming up in Malaysia in for all methods used now or in the future. fsh oils.
late February. “Some members believe this standard is When asked what’s likely to happen to the
One controversial portion of the draft is ahead of its time in the sense that it can set a draft following February’s CCFO meeting,
an extensive table listing the fatty acid com- standard of what fsh oil is today, which means MacKay says it all depends on what happens
position of oils that purportedly should be not only the oil but the fatty acid content plus at the meeting. “If numerous member states
present in specifc fsh species. CRN ques- the preservatives that are allowed to be used say they have a problem with this draft, the
tioned the accuracy of this list and its range and the types of concentration processing Commission will have to decide on what
of suggested values because it has not been that are allowed. But veterans of the dietary next steps to take,” he says.
USP Grows Food Fraud USP scientists say those categories remain companies were involved; 206 products were
leading problems, in addition to newer fraud exported to as many as 22 countries; and
Database trends recorded in 2011–2012 for seafood there were roughly 4,000 potential victims in
Te U.S. Pharmacopeial Convention (USP; ( fsh, shrimp), clouding agents, and lemon Taiwan,” USP says.
Rockville, MD) has added nearly 800 new re- juice. Also vulnerable are safron, honey, cof- Other examples of fraud include wa-
cords of fraud to its Food Fraud Database. Te fee, tea, black pepper, turmeric, chili powder, tered-down and urea-adulterated fuid
new additions refect records from 2011–2012 and maple syrup. milk in India; dilution of milk powder
and point to additional food fraud categories: USP calls fraud involving clouding agents with fllers such as maltodextrin in South
seafood, clouding agents, and lemon juice. “the 2011 equivalent to the melamine scan- America; replacement of olive oil with less-
Te Food Fraud Database documents dal involving Chinese milk products from expensive vegetable oils; and dilution or
foods most vulnerable to fraudulent manipu- a few years ago.” Clouding agents are com- replacement of spices with less-expensive
lation in the food supply, based on reports in monly used in fruit juices to improve visual spices or fllers.
ONEPONEY/ISTOCKPHOTO.COM
both scholarly journals and general media. appearance and make products look freshly USP defnes “food fraud” as “the delib-
When frst compiled, the database contained squeezed. Reports include use of the plasti- erate substitution, addition, tampering, or
1,300 records of food fraud published be- cizer Di(2-ethylhexyl) phthalate (DEHP) in misrepresentation of food, food ingredi-
tween 1980 and 2010. Tese records showed fruit juices, jams, and other products, in place ents, or food packaging, or false and mis-
milk, vegetable oils, and spices among the top of more expensive palm oil. “Te scope of this leading statements made about a product
categories for fraud. fraud was vast: 877 food products from 315 for economic gain.”
12 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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COMPANY News
FDA GRAS NOD FOR ALPHASIZE A-GPC a 3130 Genetic Analyzer and a 2100 Bioana-
llyzer for verifying each lot of Ganeden BC30
FDA has no questions about a GRAS notifi -
pprobiotics by PCR and genetic sequencing.
cation for AlphaSize, an alpha-glyceryl phos-
“In addition to the standard freezers, re-
phoryl choline (A-GPC) ingredient from Che-
frigerators, sterilizers, freeze dryers, incu-
mi Nutra (White Bear Lake, MN). AlphaSize
bbators, and bio-safety hoods typically found
targets mental and exercise performance,
in a modern microbiology lab, we also have
improving mental clarity and combating de-
a full kitchen area used for preparing our
mentias and improving muscular strength,
customers’ products as a fnal consumer
power, and reaction. The GRAS standing
wwould do, before we test for viability of
indicates AlphaSize—which is already used
Ganeden BC30,” says lead scientist Howard
in dietary supplements—is safe for conven-
Cash, PhD.
tional food and beverages.
This is a caption sample this is a caption
Chemi Nutra describes AlphaSize as a
sample this is a caption sample this is a Ocean Spray’s
“safe, natural, and rapidly absorbed form of
caption sample this is a caption sample
choline that has been shown to raise free plasma choline levels much faster than other
this is a caption sample.
First International
choline precursors.” In particular, A-GPC is a precursor of acetylcholine, the primary neu- Acquisition
A
rotransmitter involved in all brain functions and muscular contraction functions.
In a move to increase its global mar-
kket share, Ocean Spray Cranberries Inc.
(Lakeville-Middleboro, MA) has acquired
Black Currant Extract SIDI Releases Supplier
Agrícola Cran Chile Limitada (Cran Chile),
Self-Affirmed GRAS Qualification one of South America’s leading cranberry
Cyvex Nutrition Inc. (Irvine, CA) reports Guidelines growers.
that its European black currant extract is Te Standardized Information on Dietary Te Cran Chile acquisition covers an esti-
now self-afrmed GRAS and can be incor- Ingredients (SIDI) Work Group has made mated 12 million lb of yearly cranberry pro-
porated in functional foods and beverages. available supplier qualifcation guidelines for duction and gives Ocean Spray an immediate
Cyvex’s black currant extract is standard- dietary supplement manufacturers. Tis and presence in an important cranberry growing
ized for 25% anthocyanins, making it “one other self-regulatory tools are available for region and a counter-seasonal supply of
of the most potent berry extracts available download at www.sidiworkgroup.com. cranberries.
on the market.” SIDI created the supplier qualifcation
guidelines to help manufacturers achieve DSM Acquires Swedish
Natoli Founds Tablet supply chain integrity. Instead of just rely-
Oat Fiber
ing on a Certifcate of Analysis, companies
Engineering Program can use the new guidelines to establish their DSM Nutritional Products (Parsippany, NJ)
Natoli Engineering Company, Inc., (St. own methods for building relationships with has acquired Swedish Oat Fiber (Bua, Swe-
Charles, MO), a specialist in tablet compres- the right partners. Te document should be den), a specialty producer of oat bran rich in
sion parts and services, is partnering with useful to all companies, regardless of their beta-glucans. Swedish Oat Fiber will still pro-
Long Island University to found a program to size. duce its ingredients, but DSM will assume
advance knowledge of pharmaceutical oral Te SIDI Work Group is made up of the sales and marketing activities.
dosage engineering. Te Natoli Engineering Consumer Healthcare Products Association Beta-glucans have a favorable reputation
Institute will fnd a home on Long Island’s (CHPA), the Council for Responsible Nutri- among various health agencies, with EFSA
Brooklyn campus. It’s scheduled to open in tion (CRN), and the United Natural Prod- and FDA ofering their own health claims for
September 2013. ucts Alliance (UNPA). beta-glucans. Available from multiple food
“Work will focus on understanding many sources, beta-glucans have been associated
HENRICK5000/ISTOCKPHOTO.COM
of the long-time problems of sticking and Ganeden Brings Lab to with potential for cholesterol reduction,
picking associated with the compression of blood glucose control, and gastrointestinal
tablets; the development of formulations for
Cleveland Headquarters health.
new and existing molecules; and the mea- Ganeden Biotech (Cleveland) has relocated Swedish Oat Fiber distributes its OatWell
surements required to ensure proper delivery its state-of-the-art probiotics laboratory brand ingredients throughout North Amer-
of formulations to the tablet press and the from Miami to its headquarters in Mayfeld ica under Oat Ingredients LLC (Boulder,
control of the tablet press,” the frm says. Heights, OH. Te 4000-sq-ft facility features CO).
14 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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REGULATIONS
Fresh Start at the FTC?
As bureau director David Vladeck exits the FTC, will his mission endure to bring
dietary supplements under tighter regulation?
BY JOHN E. VILLAFRANCO, PARTNER, KELLEY DRYE & WARREN LLP
T his December, David Vladeck completed his tenure as direc-
tor of the FTC’s Bureau of Consumer Protection, with plans
to return to academic life at Georgetown University Law Center.
claims, and the “inefective” use of disclaimers. He also argued that
the D.C. Circuit misconceived basic First Amendment commercial
speech principles and, consequently, placed the public at undue
He will continue as a consultant to the risk. “Te tragic result of the Pearson [decision] is that consumers
FTC for the indefinite future and will be again will be exploited by health claims riddled with half-truths
replaced by Charles A. Harwood, long- and distortions and duped into taking products that may jeopar-
time FTC staff attorney, who will serve dize their health,” he said.
as acting bureau director. Mr. Vladeck argued that all unverified health claims are mis-
While at the FTC, Mr. Vladeck leading, and that health or nutrition claims that are unsupported
made it clear that he believes di- by “significant scientific agreement” are unreliable and deceptive.
etary supplements should come He criticized the Pearson court for placing the burden of verifying
under tight regulation. Now that claims in the hands of consumers, and explained that disclaimers
he’s leaving the FTC, what will his would serve no role in filling the “informational void” for prod-
legacy leave behind? ucts that do not have significant scientific support. He stated,
“nothing in the disclaimers envisioned by the Pearson court tell
A History of Cracking the consumer whether the product is safe—that fact is unknown;
Down on Supplements alert the consumer to the product’s risks—the risks are unknown;
Mr. Vladeck arrived at the FTC in tell the consumer whether the product works—that fact is un-
2009 with impressive credentials as known; and tell the consumer whether the product is more or less
a consumer advocate, including 30 effective than a conventional remedy—that fact is unknown.”
years of experience with Public Cit- If there was any doubt about Mr. Vladeck’s feelings toward the
izen Litigation Group, a prominent dietary supplements industry, doubt was dispelled at his May
public interest law firm founded by 2008 Commencement address to Georgetown University Law
Ralph Nader. The appointment sig- Center graduates. During his speech, he explained that he ac-
naled that the FTC would be aggres- cepted the position with the FTC because he believes consumer
sive in policing claims. No industry fraud is “out of control” and that he intends to fight against those
segment was more concerned by who prey upon the public with “snake oil supplements that prom-
this aggressiveness than market- ise a cure and deliver nothing.”
ers of dietary supplements—and Mr. Vladeck also made clear that the Bureau of Consumer Protec-
for good reason. tion would not limit its review to bottom-feeders and unscrupulous
Even prior to his appointment, Mr. Vladeck marketers. In an October 2009 speech to the National Advertising Di-
ILLUSTRIOUS/ISTOCKPHOTO.COM
stated his belief that tight regulation was needed for dietary sup- vision, Mr. Vladeck said that the Bureau would have a renewed focus
plements. In a review of the D.C. Circuit court’s ruling in Pearson on national advertising, going after large companies that advertise
v. Shalala—a case in which the court ruled that under the First widely and put forth deceptive or unsubstantiated claims, not just
Amendment, FDA could not ban health claims simply on the basis small companies perpetrating direct fraud. He specifcally indicated
of inconclusive evidence—Mr. Vladeck criticized the courts’ views that the Bureau would focus on health claims in advertising.
on “unverifed” health claims, consumers’ abilities to evaluate Both were promises he would keep.
16 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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GLOBAL
REGULATIONS
Once at the FTC, it was apparent that Mr. Vladeck would reau’s consumer protection mission through daring initiatives,
not be any ordinary bureau director, as he actively directed the aggressive enforcement, and effective advocacy.
Commission’s position on appeal in Lane Labs. In that case, the The industry should expect this to continue under acting
FTC convinced the district court to reverse its earlier ruling and bureau director Harwood. He is a career FTC staffer who has
hold the defendants in contempt of their prior consent order served as a deputy director under Mr. Vladeck since November
with the FTC. (The district court initially concluded that the 2009. Thus, Mr. Harwood was largely responsible for implement-
company made a good faith effort to comply with the original ing the Vladeck agenda.
consent order by retaining experts and reasonably relying on Meanwhile, Mr. Harwood’s tenure at the FTC’s Seattle regional of-
the experts’ opinions.) fce included his own past actions against supplements. Troughout
Following Lane Labs, Mr. Vladeck pushed through a more rig- the 1990s, under the direction of Mr. Harwood, the Seattle regional
orous substantiation standard in subsequent consent orders for ofce brought several complaints against dietary supplement man-
other companies. Tose consent orders had a profound efect on ufacturers and marketers and joined “Operation Waistline,” the FTC
risk analysis in the supplements industry. Consent orders began crackdown on weight-loss claims that resulted in settlements with
to include mention of new “FDA approval provisions” that gener- seven dietary supplement manufacturers nationwide. Te Seattle
ally require, 1) FDA preapproval for the afected types of claims, regional ofce led the investigation of two of these companies—
and 2) new two-trial provisions that require, for the afected types KCD Inc. and Interactive Medical Technologies (IMT)—and settled
of claims, at least two randomized, with the companies and their
double-blind, placebo-controlled hu- principals for a total of $205,000
man clinical trials conducted by dif-
Mr. Vladeck made clear that the in consumer redress over allega-
ferent researchers independently of Bureau of Consumer Protection would tions that KCD and IMT made
each other. false and unsubstantiated claims
These provisions are now com-
not limit its review to bottom-feeders about supplement products Se-
mon in consent orders and were in- and unscrupulous marketers. Quester and Lipitrol. Te compa-
cluded in orders or proposed orders nies claimed the products reduced
involving such companies as Iovate Health Sciences, Nestlé, cellulite and prevented or reduced the body’s absorption of fat from
Dannon, and Beiersdorf. And while the FTC denies that these food, respectively.
provisions form the de facto standard for companies seeking In 1999, following an investigation by the Seattle regional ofce, the
safe harbor for health claims, there is no question that the con- FTC fled a complaint against Rose Creek Health Products, Inc., alleg-
sent orders inform counsel of the FTC staff ’s opinion of the level ing that the company made false and unsubstantiated claims that its
of substantiation that is now required. Vitamin O dietary supplement could cure and prevent cancer, lung
Most recently, the FTC’s opinion was stated in an appeals case disease, chronic headaches, and infections by enriching the blood-
involving pomegranate juice and dietary supplement marketer stream with supplemental oxygen.
POM Wonderful, which appealed a May 2012 decision by Admin- Due to the Seattle regional ofce’s eforts under Mr. Harwood,
istrative Law Judge D. Michael Chappell that the company made the FTC also settled with Positive Response Marketing Inc. and Na-
unsubstantiated, deceptive health claims. In a fnal order issued tional Media Corp. for $275,000 each in consumer redress, resolving
on January 10 of this year, the FTC Commission ruled that two allegations that the companies made false claims about the dietary
randomized, well-controlled, human clinical trials are required to supplements marketed in their infomercials. Positive Response
substantiate claims that a food can treat, prevent or reduce the Marketing made unsubstantiated weight loss, hair growth, and im-
risk of “serious diseases.” As stated in the order: “Competent and potency claims about EuroTrym Diet Patch, Foliplexx, and Y-Bron,
reliable scientifc evidence shall consist of at least two randomized respectively, while National Media Corp. claimed that Crystal Power
and controlled human clinical trials (RCTs) of the Covered Product could cure breast cancer and Cosmetique Francais could reduce or
that are randomized, well controlled, based on valid end points, eliminate cellulite.
and conducted by persons qualifed by training and experience to Under Mr. Harwood’s direction, the FTC’s eyes will remain fxed
conduct such studies. Such studies shall also yield statistically sig- on the dietary supplement industry. Risk-averse companies should
nifcant results, and shall be double-blinded unless Respondents continue to closely scrutinize their marketing messages to avoid
can demonstrate that blinding cannot be efectively implemented FTC action.
given the nature of the intervention.” (Nutritional Outlook’s March is-
sue will feature more on the FTC’s fnal POM Wonderful decision.)
John E. Villafranco is a partner in the advertising and market-
ing practice at Kelley Drye & Warren LLP in Washington, DC.
New Director, Same Agenda?
Villafranco is highly respected for offering comprehensive legal
What changes should the industry expect following Mr. Vladeck’s
advice that emphasizes risk analysis and sound business prac-
exit? Probably not many.
tices for corporations involved in advertising and marketing. He
As an initial matter, Vladeck was enormously popular with
can be reached at jvillafranco@kelleydrye.com.
FTC staff and is widely viewed as having reinvigorated the Bu-
18 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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REGULATIONS
Regulatory Changes in Canada
Crucial transition periods related to Canada’s Natural Health Products Regulation.
BY TOBEY-ANN PINDER AND JACINTHA ROBERTS, DICENTRA
I n 2013, Canada’s Natural Health Products
(NHP) Regulation will see a number of sig-
nifcant transition periods end. First, Decem-
drinks, beverages, bars, and soups.
During the transition period from NHP
to food, marketers of food-like NHPs were
By December 31, 2012, all food-like NHPs—
excluding any case-by-case exceptions—
were required to have a fnal TMA letter
ber 31, 2012, marked a signifcant deadline required to apply for Temporary Marketing authorizing their sale under the food regula-
in the transition of food-like NHPs by Health Authorization (TMA) to permit their prod- tory sphere. December 31, 2012, also marked
Canada. It was the date by which all NHP-re- ucts’ continued sale in the market. TMAs the expiry of any NHP-related submission
lated submissions—i.e., exemption numbers allow eligible products to be temporarily numbers or authorizations that any food-like
(EN) and natural product num- NHPs had received prior, such
bers (NPN)—of transitioned as ENs or NPNs. Health Canada
food-like NHP products were continues to issue documen-
set to expire. Second, February tation—e.g., Notice of Refusals,
4, 2013, marked the end of the NPN Revocation—noting can-
Unprocessed Product License cellation of any associated NHP
Applications Regulations (UP- submissions or authorizations
LAR) developed by the Natural for these transitioned products.
Health Products Directorate To date, most products at
(NHPD) to address the backlog the food-NHP interface have
of NHP applications. been transitioned via TMA let-
ters. Some products, however,
Food-Like Products did not require TMAs because
Move Out of NHPs they: 1) were already compliant
Health Canada defnes an NHP— as food, 2) were not eligible for
under the NHP Regulations—as TMAs without frst being refor-
“vitamins and minerals, herbal remedies, ho- marketed under specifc conditions, while mulated, or 3) remained classifed as NHPs
meopathic medicines, traditional medicines industry collects and provides to the Food but frst needed to change their marketing
such as traditional Chinese medicines, pro- Directorate specifc required data to assist in and other representation so as not to be con-
biotics, and other products like amino acids regulatory amendment to the Food and Drug fused with a food product.
and essential fatty acids.” NHPs—which are Regulations (FDR). Tese food-like NHPs will Going forward, Health Canada an-
non-prescription items—must apply for a meet an entirely diferent set of regulations nounced it will develop category-specifc
product license and undergo premarket ap- once they are classifed as food. For instance, TMA guidance documents, which it antici-
proval before entering Canada’s market. But, companies are not required to have site li- pates fnalizing by the middle of this year.
on April 17, 2012, Health Canada formally censes for food products as they would if the Tese documents will outline requirements
BAMBAMIMAGES/ISTOCKPHOTO.COM
announced it would transition products products were NHPs, and they also may not for marketing data reporting, incident re-
that more appropriately ft the defnition of a have to provide such extensive efcacy infor- porting, and other pertinent information
food away from the NHP Regulations. Health mation on ingredients for substantiation. A for TMA food products. Te Food Direc-
Canada’s reasoning was that certain products TMA food, however, faces stricter regulation torate has signaled that there will be a rea-
regulated as NHPs are packaged, perceived, on fortifcation levels or ingredients allowed sonable transition period for companies to
represented—and thus, consumed by end in some food categories, and may have strict- bring their food-like NHPs into compliance
users—as food. Such products include energy er controls on related health claims. with the TMA requirements and expects
20 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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REGULATIONS
enforcement to be minimal during this rea-
sonable transition period.
For new food-like NHPs that have not pre-
viously been in the NHP queue, the passing
of the transition deadline marks the oppor-
tunity for new product TMA submissions
to be reviewed by the Food Directorate. As
we entered 2013, the Food Directorate con-
tinued to accept and review submissions of
new eligible TMA food products.
UPLAR Expires
Another transition period that ended relates
to UPLAR, the Unprocessed Product License
Applications Regulations. Te NHPD enact- Canada’s Natural Health Products Directorate plans to start phasing out
ed UPLAR on August 4, 2010, to ensure NHPs products without NHP market authorization on March 1, 2013.
backlogged in the queue for premarket re-
view can, in the meantime, be legally sold. alone. Furthermore, the NHPD was meet- At this time, the NHPD plans to begin
Products granted this temporary license ing its 180-day and 60-day review time phasing out products without NHP market
status received a preliminary assessment performance targets (79% of the time for authorization starting on March 1, 2013. By
for safety and efcacy and were assigned an non-traditional, traditional, and homeo- December 1, 2013—nine months from the
EN while they awaited full review. UPLAR pathic applications; and 100% of the time start of the transition—the NHPD expects
was created as a temporary solution, however,for compendial and labeling standards) for that all manufacturers, packagers, and label-
all new (post-UPLAR) applications. Tis
and expired on February 4, 2013. Tereafter, the ers will have completed stock turnover and
legislation was repealed. efciency was due to a number of NHPD should not be selling unlicensed products.
Once UPLAR expired, what happened to initiatives, including the publication of 30 Retailers and distributors will receive an ad-
pre-UPLAR submissions that were still await- new monographs in 2012 and such strate- ditional nine months from this time—until
ing premarket review? Te good news is that, gies as “batching,” in which products and/ September 1, 2014—to fnish selling their
or ingredients of the same stock of non–market authorized products.
At the end of the [NHP] tunnel will be type are assessed in batches After this time, the Compliance and Enforce-
to expedite review time and ment Policy (POL-0044) will come into full
marketplace fairness. [And] Canadian provide consistency in re- efect, and products without market autho-
consumers will receive products that viewer decisions. rization should not be sold.
After UPLAR’s expiry on In the end, we believe full-scale enforce-
they know to be safe and effective— February 4, no products ment of the NHP Regulation will be good for
a good image for our industry. should remain in the assess- industry. For companies that have diligently
ment queue with an EN; by worked with the NHPD process—as fawed
at the time of this writing, NHPD appeared this date, all NHP applications should have as the process has been at times—at the end
to be on track with clearing its backlog of received a decision. Many in the industry of the tunnel will be marketplace fairness.
pre-UPLAR NHP assessments by February 4. questioned what to expect regarding com- Tose that comply with the regulations and
Of the 10,885 pre-UPLAR submissions—con- pliance and enforcement once UPLAR ex- produce high-quality NHPs for the public will
sidered to be any new submission or amend- pired. Te NHPD has clearly indicated that be rewarded for their patience. In turn, Ca-
ment received by the NHPD prior to August it will maintain its compliance and enforce- nadian consumers will receive products that
5, 2010—86% of them completed NHP review ment risk-based approach and is quick to they know to be safe and efective—a good
by October 2012. As a result, these products emphasize that the end of UPLAR does not image for our industry.
were either approved, refused, or withdrawn signal a change in its approach to com-
by the applicant. pliance and enforcement activities. Fur- Tobey-Ann Pinder is the resident food
ONURDONGEL /ISTOCKPHOTO.COM
As we approached the end of UPLAR, thermore, NHPD recently met with stake- regulatory expert at Dicentra. She is both
1534 pre-UPLAR applications still await- holders and reviewed industry feedback a licensed naturopathic doctor and a law-
ed assessment. Although this number regarding appropriate transition timelines yer. Jacintha Roberts works in regulatory
sounds quite large, the NHPD was working and a compliance promotion period for affairs for natural health products at Di-
steadfastly to meet its goal of clearing the transitioning to full-fedged compliance centra. She is a biomedical engineer who
backlog, with 1593 pre- and post-UPLAR and enforcement of non–market autho- has worked in site licensing at the NHPD.
applications assessed in October 2012 rized products.
22 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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MARKETING
GLOBAL
Can the Market Mature?
Thus far, the antiaging category hasn’t grown much beyond antioxidants.
BY INNOVA MARKET INSIGHTS
H ealthy aging remains a key trend for
product development and marketing in
2013. However, marketing to this audience is
mins, omega-3 fatty acids, coenzyme Q10,
and glucosamine.
Relatively high-profle ingredients just
vision, and overall
health with natu-
rally occurring, high
complicated. Instead of labeling products spe- starting to appear in mainstream food prod- levels of polysac-
cifcally as “antiaging,” for instance, many mar- ucts include resveratrol, a powerful antioxi- charides and anti-
keters focus more generally on overall health dant claimed to help prevent the free radical oxidants such as ze-
maintenance and protection with antioxi- damage that can lead to premature aging of axanthin and lutein.
dants and other benefcial ingredients. Why? cells. Resveratrol has been linked to benefts Te company also
Because many consumers prefer not thinking for cardiovascular health and anti-infamma- ofers Goji Vitamin
of themselves as “elderly.” tory processes, as well as antiaging proper- Chews with similar
Less than 0.1% of the global food and drink ties that help promote youthful energy and purported benefts. Activate’s Defy
launches Innova Market Insights recorded appearance. While the ingredient is relatively Blueberry Pom
in the 12 months ending October 2012 were well established in the dietary supplements The Future
positioned specifcally on an antiaging or “ag- market, it is starting to appear more regularly When asked why antiaging shows promise
ing well” platform. By contrast, ten times that as a component of U.S. beverage and confec- for continued growth, Activate Drinks vice
number, or over 1%, were marketed as high in tionery launches. Launches in 2012 included president of marketing Jesse Merrill says,
antioxidants. Genesis Today’s juice drink Pomegranate & “Consumers are starting to think about the
Te antiaging category is highly fragmented, Berries with Resveratrol and the frst resver- aging process at a much earlier age and are
with products focusing on a broad and diverse atrol-fortifed chewing gum, Cheiron’s Heart taking measure to maintain their health and
range of ingredients and general benefts. Al- Strong Gum, which claims to have 40 times appearance as early as in their 20s. A beau-
though key antiaging concerns include cogni- more resveratrol than a glass of red wine. tiful and healthy appearance is a hot topic
tive function, eye health, bone and joint health, In the United States, another example of a that’s highlighted in popular culture, and
and more general categories of immune health beverage ofering antiaging benefts is Acti- consumers are much more aware that what
and heart health, companies are increasingly vate. Its vitamins and nutrients are housed in you put in your body afects your health, ap-
targeting these areas with everyday foodstufs a cap on top of the drink bottle, and they pour pearance, and overall well-being....Consum-
instead of creating “antiaging” products spe- into the liquid only when the consumer opens ers are being proactive in seeking products
cifcally advertising these benefts. the product. Te Activate line includes Defy that meet these needs.”
Blueberry Pom and Beauty Exotic Berry, which
Products and Ingredients contain powerful ingredients such as vitamins
What types of products and ingredients have A, C, and E; tea polyphenols; and epigallocate- Innova Market Insights is your source for
healthy-aging benefts? “Superfruit” juices chin-3-gallate (better known as EGCG). new-product data. The Innova Database
such as pomegranate, cranberry, and goji, Carotenoids—particularly lutein and ze- (www.innovadatabase.com) is the prod-
for starters. Demand for these juices is rising axanthin—are linked with eye health and the uct of choice for the whole product devel-
strongly alongside demand for other function- protection of eyes against age-related macu- opment team, offering excellent product
al drinks that imply specifc health benefts. lar degeneration (AMD). But their use hasn’t pictures, search possibilities, and analysis.
Demand for products that straddle the bound- moved much outside of supplements. Tere See what food manufacturers are doing
ary between mainstream food and drinks and are some exceptions: in some supplement- around the world. Track trends, competi-
dietary supplements, such as supplement-style style health drinks, for instance, carotenoids tors, ingredients, and flavors. In today’s
drinks and chews, is also growing. have appeared in combination with other nu- fast-moving environment, this is a resource
Other active ingredients used in the ag- trients. Genesis Today’s Goji 100 drink, for ex- you cannot afford to be without.
ing-well category include antioxidant vita- ample, claims to help improve mood, memory,
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Safeguarding
Energy Drinks
To survive scrutiny and ensure a healthy future, energy drinks must court the responsible
consumer. This requires formulating wisely.
BY KIMBERLY J. DECKER
W
ith U.S. energy drink sales slated Margaret Hamburg, FDA commissioner, not- In the meantime, energy drink manufac-
to more than double in 2013, ing in particular their concerns about mar- turers must operate in a tentative regulatory
potentially raking in as much as keting practices that target youth, lax regula- environment. But that doesn’t mean they
$19.7 billion in revenue, according to Data- tions regarding cafeine, and the ambiguous can’t make changes to improve the reputa-
monitor fgures, you’d expect manufactur- boundary separating energy beverages from tion of their products and, perhaps more
ers’ hands to be full—with celebratory glasses supplements. crucially, their potential to maintain a clean
of bubbly. But maintaining a grip on those Of course, whether energy beverages are safety record. Clearly, the place to start is an
Champagne futes could get tricky, as indus- in fact beverages and not just supplements ingredient review.
try leaders’ palms break into a sweat over a administered by straw is a question lawyers
spate of illnesses and even deaths linked to will litigate long after a new product has Caffeine in the Crosshairs
the popular drinks. seized Capitol Hill’s notice. But on the fun- Which ingredient to start with? With the one
Since 2009, FDA has received hundreds damental question of safety, it’s important ingredient most decisive in establishing en-
of safety incident flings, with as many as 90 to remember that a link between an adverse ergy drinks’ success—and the one most liable
linked to one liquid energy product alone: health event and energy beverage consump- for the current controversy: cafeine. From
5-Hour Energy, distributed by Living Essen- tion does not necessarily a causal relation- South America to Arabia, today and through-
tials (Farmington Hills, MI). Te incidents ship make. out history, millions have relied on cafeine
cited range from convulsions and heart at- Indeed, FDA has yet to move aggressive- for mental stimulation and physical acuity.
tacks to a case of spontaneous abortion, ac- ly on energy beverages because it doesn’t How cafeine provides these benefts is
cording to The New York Times, and they’ve believe it has sufcient evidence to do so. well-trod territory. Researchers have deter-
brought a food of negative attention to the Nevertheless, the agency plans to work with mined that it attaches to receptors that nor-
category from government agencies, watch- outside groups, including the Institute of mally bind the neurotransmitter adenosine.
dog groups, and anxious consumers. Medicine, to “strengthen our understanding” Adenosine’s job is to signal the central nervous
Te ink spilled on energy drinks could fll a of the products, with a focus on “such mat- system (CNS)—via those receptors—that it’s
superstore beverage section, and the heated ters as the vulnerability of certain popula- time to slow things down and go to sleep.
discussion that’s followed has compelled tions to stimulants and the incidence and But if adenosine can’t communicate with the
lawmakers to petition FDA to increase its consequences of excessive consumption of CNS because its receptors are already bind-
oversight of the category. Most vocal among ‘energy drinks,’ especially by young people,” ing cafeine, the “get to bed” message remains
the Washington critics are Senators Rich- Michele Mital, FDA’s acting associate com- unheard and the body stays awake.
ard Durbin (D-IL) and Richard Blumenthal missioner for legislation, wrote in a response Further, cafeine may be one of the world’s
(D-CT). In October 2012, they sent a letter to to Senator Durbin. most widely used “performance-enhancing
26 JANUARY/FEBRUARY 2013 ■ NUTRITIONAL OUTLOOK
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