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Keep Joints

on Point

Top ingredients for supporting healthy joints

A SPECIAL ALL-DIGITAL ISSUE VOLUME 5 ISSUE 7 $20.75 US August 2015

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2 • Keep Joints on Point Digital Issue • August 2015 | naturalproductsinsider.com

CONTENTS

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Copyright © 2015 Informa Exhibitions LLC. All rights reserved. The publisher reserves the right to accept or reject any advertising or editorial material. Advertisers, and/or their agents, assume the responsibility for all content of published advertisements and assume responsibility for any claims against the publisher based on the advertisement. Editorial contributors assume responsibility for their published works and assume responsibility for any claims against the publisher based on the published work. Editorial content may not necessarily reflect the views of the publisher. Materials contained on this site may not be reproduced, modified, distributed, republished or hosted (either directly or by linking) without our prior written permission. You may not alter or remove any trademark, copyright or other notice from copies of content. You may, however, download material from the site (one machine readable copy and one print copy per page) for your personal, noncommercial use only. We reserve all rights in and title to all material downloaded. All items submitted to NATURAL PRODUCTS INSIDER become the sole property of Informa Exhibitions LLC.

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• •

A SPECIAL ALL-DIGITAL ISSUEVol. 5, No. 7 August 2015

3 Viewpoint

4 Joint Ventures Joint health should be addressed

from an early age, and consumers

are realizing that. In this article by

Celeste Sepessy, we’ll explore global

research trends in joint health ingredients

such as curcumin and omega-3s.

12 Joint Health: State of the MarketThe current focus shaping the joint health

market involves preventative care and

the support of heathy joint function using

natural ingredients. Kate Lloyd delves

into today’s chart-topping ingredients,

which formats consumers want, and

who’s most interested in joint health.

16 Maintaining, Supporting Joint Health ClaimsAttorney Justin J. Prochnow offers

tips for ensuring compliance to FDA and

FTC regulations related to joint health.

20 Takeaways for Your Business• •


VIEWPOINT

Joint Health Education

Finished supplement brand Osteo Bi-Flex® recently launched a campaign aimed at educating consumers

about joint health with a focus on how nutrition and lifestyle affect joints throughout life. As its website explains, consumers of all ages should pay attention to their knees, ankles and other joints in order to preserve joint health for a lifetime.

Osteo Bi-Flex commissioned a survey in 2014 that found nearly seven in 10 Americans over 34 years of age experience joint stiffness or other concerns, which spurred the creation of online content directed at consumers. It offers articles on joint function, the importance of supplementation in joint health (specifically using Osteo Bi-Flex’s products), “low impact living” and active lifestyles.

This site caught my attention because it shows two things: the growing trend of content marketing that brands can to do connect to consumers and the growing importance of joint health education.

While Osteo Bi-Flex focuses on teaching consumers, Natural Products INSIDER is here to help brands offering finished products. Joint health has been a staple in the supplement business, with the big boys glucosamine and chondroitin historically leading the pack.

And while the research on glucosamine and chondroitin’s benefits to joints continues to mount, the widening market has allowed for other ingredients—such as collagen, natural eggshell membrane (NEM), omega-3s and more—to flourish in the joint health space.

As more consumers are realizing the need for joint care starts way before pain sets in—thanks to education from the media and companies like Osteo Bi-Flex—the market is still large at $317.4 million, although sales have been declining in recent years, according to SPINS.

Brands will continue to look for new ingredients and marketing messages to entice sales, but they need to be sure their claims stay in the legal realm. Getting warned by FDA or FTC is never good for business.

This Digital Issue covers all these joint health topics and more, so brands can effectively and legally market their research-backed ingredients to consumers looking for a lifetime of flexibility.

Sandy AlmendarezEditor in Chief, Natural Products INSIDER(480) [email protected]

@SandyAlmendarez


Joint VenturesGlobal research trends in joint health ingredients

by Celeste Sepessy

People around the world are living longer … and heavier. And what’s shouldering the

load for that lifetime of heavy steps? That would be your joints—all 360 of them.

“Joint health represents the number one condition-specific supplement category being used by American adults,” said Paul Dijkstra, CEO, InterHealth Nutraceuticals. That reach extends globally, as Global Industry Analysts predicted the bone and joint product market to reach USD $9 billion by 2017.

According to Vanessa Agnolutto, communications manager at Nexira, joint health consumers can be split up into three groups that turn to specialized ingredients:

Due to the complex need, many joint health ingredients target three main areas—promoting healthy joint tissues, protecting against inflammation and relieving pain. In some cases, ingredients tackle all three mechanisms of action.

Dietary supplement manufacturers take note: Joint health should be addressed from an early age, and consumers are realizing that.

“In the last couple of years, there has been a great number of studies focused on preventative care for joint health using natural products,” said Anurag Pande, Ph.D., vice president of scientific affairs, Sabinsa. The results have been overwhelmingly positive, he said.

IN THIS ISSUE

Viewpoint p. 3

Joint Health: State of the Market p. 12

Table of Contents p. 2

JOINT HEALTH RESEARCH

INSIDER’s Take

¾ Baby Boomers, the overweight/obese and active middle-aged adults are seeking natural solutions for joint support.

¾ Many ingredients target protecting and regenerating joint tissue such as cartilage.

¾ Compounds such as curcumin and omega-3s help to quell inflammation in the joint structure.

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1

Baby Boomers who hope to continue an active lifestyle,

2

Overweight/obese individuals facing joint pain, and

3

Middle-aged adults looking to proactively preserve joint health.

B I O A V A I L A B L E C U R C U M I N



Healthy Tissues, Healthy JointsAs humans grow old, their joint tissues follow suit. Over time, cartilage wears

down from normal everyday activities; those with physically active or demanding lifestyles often feel the effects of osteoarthritis (OA) sooner than they’d like. As a result, many natural ingredients target cartilage in some form or another—whether protecting or repairing the collagen-heavy tissue.

“Daily wear and tear of the joints leads to release of pro-inflammatory cytokines and upregulation of collagenases and aggrecanases by chondrocytes, ultimately leading to the breakdown of joint cartilage and the extracelluar matrix,” Dijkstra said. “Pain and stiffness soon follow.”

It comes as no surprise that undenatured type II collagen is a key ingredient for bolstering joint health. The ingredient has been reported to benefit both OA and healthy populations in clinical trials. After taking 40 mg of UC-II (from InterHealth Nutraceuticals) for 120 days, healthy subjects had significantly improved knee extension and exercised longer before experiencing joint pain, compared to placebo.1 In OA populations, research has shown UC-II improves joint comfort, mobility and flexibility, reducing WOMAC scores by 33 percent.2

Despite facing some controversy in recent years, glucosamine and chondroitin are recognized as the go-to compound combination for restoring joint health. Fresh research from the Annals of Rheumatic Diseases compared glucosamine and chondroitin sulfate to celecoxib, a nonsteroidal anti-inflammatory drug (NSAID).3 The double blind, multi-center trial of 606 patients with knee OA found chrondroitin plus glucosamine supplementation (as CosaminDS from Nutramax Laboratories) just as effective as the NSAID. “Both groups elicited a reduction [of] more than 50 percent in the presence of joint swelling; a similar reduction was seen for effusion,” the authors wrote.

Comprised of collagen, chondroitin sulfate and hyaluronic acid (HA)—basically, the building blocks of connective tissue—natural eggshell membrane (NEM) offers a sustainable ingredient option for joint health. In 2014, one Journal of Arthritis-published, six-center study touted a single 500-mg dose of NEM to reduce joint discomfort and increase flexibility.4 The ingredient is also slated for a new study in Journal of Inflammation Research’s spring publication.

Many natural ingredients target cartilage in some form or another—whether protecting or repairing the collagen-heavy tissue.



“The newest study focuses on the potential role of NF-KB, an important signaling protein involved in innate immunity, in the efficacy of NEM,” said Nina Dockery, technical services director, Stratum Nutrition. “By regularly consuming small amounts of joint health components (i.e., chondroitin, HA, collagen, etc.) found in NEM, the immune system is trained to be tolerant of cartilage fragments that result from everyday wear and tear of joints.

As the primary component in synovial fluid, HA is a crucial player in healthy joints. The compound, which is also found in eyes, acts as a lubricant and a cushion in the joints. According to Japanese researchers, daily dosages of 200 mg of HA improved pain and stiffness in OA subjects’ knees, and daily life condition significantly improved compared to placebo throughout the study and after 12 months.5

Anti-inflammatory Protection“Many consumers today live in a state of chronic inflammation, which can

increase the risk of many health conditions and diseases,” said Becky Wright, marketing director, Aker BioMarine Antarctic US. And aching, painful joints are one consequence felt across the world. The World Health Organization (WHO) recognizes major musculoskeletal conditions as a significant burden, with OA affecting approximately one-third of those aged 65 and older.

Natural ingredients positioned for joint health often target healthy inflammatory responses, with omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) topping the list.

In a study of 90 patients with elevated C-reactive protein (CRP) levels, krill oil (as Neptune Krill Oil [NKO] from Neptune Technologies and Bioressources) reduced CRP by 29.7 percent in 14 days, compared to an increase of 32.1 percent for the placebo group.6

“Krill’s phospholipid omega-3s support a healthy inflammatory response, helping to normalize C-reactive protein levels and reduce arthritis symptoms,” Wright explained. “Elevated levels of inflammatory mediators derived from omega-3s result in weaker inflammatory reactions.”

Fatty acids from bovine tallow oil also offer effective and natural anti-inflammatory compounds. Patients taking cetylated fatty acids (as Celadrin from Proprietary Nutritionals Inc.) improved knee range of motion and overall function in patients with knee OA.7 Subjects took either placebo or 350 mg of Celadrin for 68 days. David Foreman, RPh, N.D., and host of “The Herbal Pharmacist” radio show, noted, “It works by decreasing inflammation and lubricating cell membranes throughout the body, restoring fluids that cushion bones and joints to promote flexibility and mobility.”

As the primary component

in synovial fluid, hyaluronic

acid (HA) is a crucial player

in healthy joints. |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

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“Curcumin has a long history of medicinal use due to its anti-inflammatory and antioxidant properties, and the science around curcumin has increased dramatically over the years with over 7,000 citations currently in PubMed,” said Lynda Doyle, vice president of global marketing at OmniActive Health Technologies. As the bioactive component of turmeric, curcumin interacts with multiple inflammatory pathways—inhibiting pro-inflammatory cytokine release and thereby suppressing inflammation.

New research from Baqiyatallah University of Medical Sciences, Tehran, Iran, solidifies curcumin’s benefits for OA. Subjects with OA took either 1,500 mg/d of curcumin (as Curcumin C3 Complex from Sabinsa) or placebo for six weeks.8 Supplemented patients had significant reductions in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne’s pain functional index (LPFI) scores. Of particular note were the improvements in pain and physical function markers. “The systemic inflammation markers were also studied, and it was believed that the benefits of curcumin in osteoarthritis arise from the reduction of inflammation in the osteo-cartilagenous tissue without impacting significantly the systemic biomarkers,” Pande said.

More Botanical Pain ReliefHops cones have been shown to alleviate pain and stiffness, according

to David Foreman, RPh, N.D., and host of “The Herbal Pharmacist” radio show. “Unlike glucosamine and chondroitin that can take weeks or months to work, hops cones typically starts relieving minor pain within the first 30 minutes of taking it in supplement form,” Foreman said. Standardized hops extract has proven helpful for OA patients in pain. According to one double blind, placebo-controlled study, 1,000 mg of daily of hops extract (as Perluxan from Pharmachem Labs) increased joint comfort parameters such as sitting and walking on a flat surface.12

But hops isn’t the only pain-relieving botanical. “Devil’s claw extract is traditionally used to help reducing pain related with joint inflammation,” said Vanessa Agnolutto, communications manager, Nexira. In a four-month study of 122 patients, devil’s claw “was at least as effective as a reference drug (diacerhein) in the treatment of knee or hip osteoarthritis and reduced the need for analgesic and nonsteroidal anti-inflammatory therapy,” according to study authors.13 Subjects took either 2,610 mg of devil’s claw or 100 mg of medication daily; both groups experienced considerable improvements in OA symptoms and pain measures, but supplemented patients had fewer adverse events.




In a 2010 study, curcumin (as Meriva® by Indena) was evaluated for its efficacy in 50 patients affected by bone health challenge.9 For the study, patients were randomly divided into two groups and received either 1 g/d of Meriva (in two separate administrations) and the “best available treatment,” or the “best available treatment” alone, as defined by the patients’ general practitioners or specialists over a three-month period. Symptoms were evaluated using the WOMAC score; mobility was studied by walking performance on a treadmill; and the overall inflammatory response function was assessed by measurements of C-reactive protein (CRP) plasma concentration.

Results showed an improvement in treadmill performance (201 percent of the initial walked distance at two months), and further improvement (an additional 44 percent) at three months. The results were complemented by secondary endpoints, including a decrease in supplemental therapy use (63 percent in the Meriva group versus 12 percent in the treatment group).

A larger and longer study examined the effects of Meriva in 100 patients over the course of eight months.10 Methodology was similar to the previous study, including the dosage (1 g/d of Meriva, corresponding to 200 mg of curcumin/d, in two separate administrations). The results showed the Meriva-treated group enjoyed a statistically significant reduction in all primary clinical endpoints, WOMAC score (decreased from 80.6 to 33.2), the Karnofsky Performance Scale (improved from 73.3 to 92.2), and the treadmill walking performance test.

In a double blind, placebo-controlled trial of 100 subjects, methylsulfonylmethane (MSM) showed promise in OA support.11 After 26 weeks of 6 g/d of MSM or placebo, researchers reported, “MSM improved all physical symptoms in the WOMAC scale during the short intervention without any adverse events.”

“While MSM’s mechanism of action is not fully understood, in-vitro studies, along with both animal and human trials, have shown MSM helps mitigate the oxidative stress that can lead to chronic inflammation,” according to Rodney Benjamin, Bergstrom Nutrition’s director of research and development.

Reducing chronic inflammation in the joints and promoting tissue regeneration are two key components in joint health. Moving forward, it’s up to dietary supplement manufacturers to invest in the research to support efficacious ingredients that can keep the world’s joints cushioned and comfortable. ¾



References

1. Lugo JP et al. “Undenatured type II collagen (UC-II®) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers.” J Int Soc Sports Nutr. 2013;10:48.

2. Crowley DC et al. “Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial.” Int J Med Sci. 2009;6:312-321.

3. Hochberg M et al. “Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib.” Ann Rheum Dis doi:10.1136/annrheumdis-2014-206792.

4. Danesch U, et al. “NEM Brand Eggshell Membrane Effective in the Treatment of Pain Associated with Knee and Hip Osteoarthritis: Results from a Six Center, Open Label German Clinical Study.” J Arthritis 3: 136.

5. Tashiro T et al. “Oral Administration of Polymer Hyaluronic Acid Alleviates Symptoms of Knee Osteoarthritis: A Double-Blind, Placebo-Controlled Study over a 12-Month Period.” Sci World J. 2012. Vol. 2012, Article ID 167928.

6. Deutsch L. “Evaluation of the effect of Neptune Krill Oil on chronic inflammation and arthritic symptoms.” J Am Coll Nutr. 2007 Feb;26(1):39-48.

7. Hesslink R et al. “Cetylated fatty acids improve knee function in patients with osteoarthritis.” J Rheumatol. 2002 Aug;29(8):1708-12.

8. Panahi Y et al. “Curcuminoid treatment for knee osteoarthritis: a randomized double-blind placebo-controlled trial.” Phytother Res. 2014 Nov;28(11):1625-31. doi: 10.1002/ptr.5174. Epub 2014 May 22.

9. Belcaro G et al. Panminerva Medica 2010 Giugno;52(2 Suppl 1).55-62.

10. Belcaro G et al. Altern Med Rev. 2010 Dec;15(4):337-44.

11. Pagonis T et al. “The Effect of Methylsulfonylmethane on Osteoarthritic Large Joints and Mobility.” Intl J Ortho. 2014 Jan.

12. Jager R, Purpura M. “Efficacy of Oral Perluxan Intake: A Randomized, Double-Blind Study.” Pharmachem Laboratories, Kearny, NJ.

13. Leblan D et al. “Harpagophytum procumbens in the treatment of knee and hip osteoarthritis. Four-month results of a prospective, multicenter, double-blind trial versus diacerhein.” Joint Bone Spine. 2000;67(5):462-7.


Joint Health: State of the MarketAn update on chart-topping ingredients, new formats and who’s buying

by Kate Lloyd

Joint pain may start as innocently as a creak in the knee or click in the elbow, but

with today’s rising incidences of obesity, the population’s love for athletics and a wide prevalence of joint-afflicting conditions affecting all ages, these issues can quickly become much more serious. An estimated one-fifth of U.S. adults suffers from doctor-diagnosed arthritis (according to the Centers for Disease Control and Prevention [CDC]), and two-thirds of obese people are likely to develop symptomatic knee osteoarthritis (OA) in their lifetime, making joint health a major concern for a large chunk of the population.

Americans are reporting bone health and strength, the ability to carry out activities in old age, arthritis and joint pain as their top bone and joint concerns, according to Catherine Adams Hutt, Ph.D., RD, CFS, chief science and regulatory officer, Sloan Trends. Arthritis has been one of the country’s fastest growing health concerns since 2006, she added, and compared to other major health issues, the population is most active in both arthritis management and treatment.

“Joint health is among the largest and fastest accelerating mega-mass market opportunities,” Hutt said. “It is a multi-faceted market segment, and in some cases, it is virtually untapped. There is very high potential for new growth, particularly for supplements.”

The current focus shaping the joint health market involves preventative care and support of heathy joint function using natural ingredients. Some of the most popular and best-selling ingredients on the market today include curcumin, boswellia, omega-3s, methylsulfonylmethane (MSM), glucosamine, chondroitin, vitamin D, calcium and amino acids, among others.

Popular Ingredients for Joint HealthOn a global scale, multivitamins are topping the charts

(valued at approximately USD $8 billion), followed by omega-3s/fish oils ($3 billion), according to Reuben Sequeira, Frost & Sullivan’s food and agriculture research analyst.

IN THIS ISSUE

Joint Ventures p. 4

Regulatory p. 16


MARKET

INSIDER’s Take

¾ Americans report bone health and strength, the ability to carry out activities in old age, arthritis and joint pain as top bone and joint concerns.

¾ Obesity is a large contributing factor in the market, as carrying around extra weight causes more wear and tear on the joints.

¾ Traditional ingredients such as glucosamine and chondroitin experienced decreased sales, which may make room for boswellia, ginger and curcumin.

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MARKET

These established dietary supplements address issues beyond joint health alone, making them popular worldwide; Sequeira added that there is more research, information and “aggressive marketing” helping these products make gains in the market. He also listed vitamin D, calcium, glucosamine and chondroitin, and amino acids as some of the most popular ingredients for joint issues globally.

“While the first three mentioned [vitamin D, calcium, glucosamine and chondroitin] are highly applicable to joint health, they are limited in their functionalities addressing other health conditions,” Sequeira said. “Nevertheless, as more concrete information/research is disseminated, consumers will target buying specific dietary supplements that cater to a specific health condition. This may or may not devalue the use of multivitamins, but it will distinguish the purported claims.”

The Fall of Traditional Ingredients?Certain joint health ingredients are certainly on the rise, but as a whole, the

sector had a less-than-stellar 2014 in terms of U.S. sales. According to data collected by SPINS, which tracks sales of vitamins, supplements, herbs and homeopathics marketed for joint health (within the U.S. combined natural and conventional channels), the segment experienced an 11.6-percent decrease from December 2013 to November 2014 (USD $358.9 million to $317.4 million). Among the top primary ingredients across all channels, glucosamine/chondroitin combinations fell 16.7 percent ($246.6 million to $205.5 million), while chondroitin alone fell 26.9 percent ($3.0 million to $2.2 million). However, collagen products experienced an increase of 33.5 percent ($1.6 million to $2.1 million) and boswellin or boswellia rose 56.5 percent ($1.2 million to $1.9 million).

Traditional ingredients for joint health—such as glucosamine and chondroitin—may have experienced decreased sales due to fact they’ve been “overplayed” in the market, Hutt said. She added that these ingredients are helpful for some of the population, but not all, due to studies showing they can help certain consumers with specific types of joint pain. The goal of effective ingredients, she said, should include anti-inflammation and maintenance of

Top 10 Joint Health Ingredients

Glucosamine/Chondroitin combo

Glucosamine

Hyaluronic Acid (HA)

Krill Oil

Chondroitin

Collagen

Maca

Vitamin C

Boswellin or Boswellia

Cherry Fruit

* Source: SPINS—includes best-selling ingredients in the U.S. conventional multi-outlet channel.


MARKET

normal joint physiology. This means the market may see a rise in sulfur sources of MSM; S-Adenosyl methionine (SAMe); anti-inflammatories such as boswellia, ginger and curcumin/turmeric; as well as natural egg shell membrane and undenatured collagen type-2.

Results from a 2013 Council for Responsible Nutrition (CRN) consumer survey indicated glucosamine and chondroitin were sitting pretty as two of the top joint health ingredients in recent years; however, the latest sales data shows these two “joint health leaders,” as titled in INSIDER’s 2014 Joint Health Digital Issue, may not uphold their first-place spots for long.

Who’s Buying?Marketing to the proper demographics plays a huge

role in joint health ingredient sales. When manufacturers consider their audiences, it’s easy to assume the elderly will be the biggest buyers. However, according to Hutt, this is not always the case.

“One of the biggest misconceptions is that arthritis is a disease of older consumers,” she said. “In fact, more than two-thirds of consumers who suffer from arthritis and joint pain are under age 65.”

Hutt added that the popularity of sports, a high number of physically-intensive jobs within the United States, and pain that comes from conditions in younger Americans all offer opportunities to target various populations when marketing for joint health. The Hispanic market is a specific demographic to keep in mind due to the population’s interest in preventing future joint issues caused from working. Consumers with jobs requiring physical labor, as well as sports enthusiasts, often look to natural products that can support their bones and joints.

Compare past trends in the joint health sector with current data by downloading the article “Joint Health Market Update” in INSIDER’s 2014 Joint Health Digital Issue.

A SPECIAL ALL-DIGITAL ISSUE VOLUME 4 ISSUE 1 $20.75 US January 2014

NATURALPRODUCTS

®

See Inside:•Joint Health Market

Skews Younger

•Legal Inflammation Claims

Double- Jointed Natural ingredients

soothe aching joints with science

Consumers with jobs requiring physical

labor, as well as sports enthusiasts,

often look to natural products that can

support their bones and joints.


MARKET

“If your joints hurt, it’s hard to want to come to work—or work out,” Hutt concluded.

Obesity is another contributing factor in the current joint health demographic, as carrying around extra weight often causes more wear and tear on the joints. Anurag Pande, Ph.D., vice president of scientific affairs, Sabinsa, reiterated that joint health problems are no longer limited to old age, and with obesity affecting the younger generation specifically, this offers yet another opportunity for companies to target a broad range of ages.

Up-and-Coming FormatsAnother factor joint health supplement manufacturers should be aware of

includes consumer-preferred delivery formats. Solid dosage formats such as caplets and capsules remain the most popular choices, Pande said, but the new bilayer tablets recently introduced by Sabinsa could also aid consumers by offering a different dosage delivery option. With the bilayer tablets, users can benefit from a slower release of nutrients to prolong the effects of joint inflammation management and pain reduction. Liquid dietary supplements may also become more popular in the sports nutrition arena for athletes looking for practical ways to care for their joints.

Consumers of all ages will continue turning to the growing list of natural products to soothe their aches and pains, as well as prevent future joint issues. Whether it be a European athlete or an American office worker, the population continues to demand high-quality ingredients for joint health, promising to drive the market forward. ¾


Maintaining, Supporting Joint Health Claims

by Justin Prochnow

“Creaky back and aching joints? Have I got a product for you!” or

“Try Arthrit-A-Cure to maintain normal joint function.” Joint products seem to have proliferated on the shelves of health food stores and across the Internet as people look to address joint health or issues. Yet, companies selling non-drug products for joints must be careful in how such products are marketed to consumers. Products making joint claims have found their way onto the radar of federal agencies tasked with regulating such claims, as well as plaintiff lawyers looking for their next class action lawsuit target. Accordingly, companies must be aware of the primary considerations for formulating joint claims that are both compliant, and not false or misleading to consumers.

Federal Regulation of ClaimsBoth FDA and FTC regulate health claims made for food, beverage and

dietary supplement products, including claims pertaining to joints. FDA has the primary responsibility for regulating claims made on product labeling, which includes product labels and other written, printed or graphic material accompanying products (according to 21 U.S.C. 321[m]), such as inserts, brochures, other promotional materials and even websites. Meanwhile, FTC regulates all claims in advertising, including print, television and radio ads, catalogs and direct marketing materials. While FDA, pursuant to a memorandum of understanding between FDA and FTC, has primary responsibility for regulating materials that may constitute both labeling and advertising, some claims, such as material appearing on company websites, may be reviewed by both agencies.

LabelingFDA reviews labeling claims made for conventional foods

and supplements with the primary purpose of ensuring that claims are permissible for the type of products being marketed—for conventional food, beverages and dietary supplements. Section 6 of the Dietary Supplement Health and Education Act of 1994 (DSHEA), under the Federal Food, Drug

IN THIS ISSUE

Market p. 12

Takeaways p. 20


REGULATORY

INSIDER’s Take

¾ FDA regulates joint claims made on product labeling, while FTC regulates claims in advertising.

¾ FDA has taken a clear public position with respect to joint claims.

¾ Label claims may not suggest that a product will be effective in the diagnosis, treatment, cure or prevention of disease.

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REGULATORY

and Cosmetic Act (FD&C), provides that claims may be made for dietary supplements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans (21 U.S.C. 343[r][6]). However, claims may not suggest that a product will be effective in the diagnosis, treatment, cure or prevention of disease.

FDA has taken a clear public position with respect to joint claims. In the discussion of the final rule on structure/function claims (65 FR 1000), FDA addressed several joint claims that it views as disease claims. The claim “improves joint mobility and reduces joint inflammation and pain” is deemed an implied disease claim for the treatment of rheumatoid arthritis (65 FR 1000, 1013). Similarly, the claim “reduced joint pain” is viewed by FDA as a disease claim in that it is a claim for the treatment of one of the main signs or symptoms of arthritis (65 FR 1000, 1016). A permissible claim would be “supports joint cartilage and joint function” because it relates to maintaining normal joint function rather than treating joint pain (65 FR 1000, 1017).

FDA has generally acted consistently with the statements regarding joint pain made in the Final Rule on structure/function claims. FDA issued and posted 21 warning letters between 2012 and 2014 to companies making “joint pain” claims, asserting that such claims are disease claims causing products labeled as dietary supplements, foods or beverages to be drugs. For instance, in a recent letter to a supplement manufacturer, FDA cited claims of “Analgesic, Anti-Inflammatory, Joint Pain. . . Arthritis” as indicative of disease claims. Similarly, a May 8, 2013 letter identified the claim “. . . to help you rid your body of joint pain and discomfort” made for the company’s product named “Arthri-Attack” as a disease claim. (Additionally, based on discussion in FDA’s final rule on structure/function claims regarding product names, the name “Arthri-Attack” carries with it a high degree of risk that it will be deemed by FDA as an implied disease claim for the treatment of arthritis (65 FR 1000, 1022).

The claim “improves joint mobility and

reduces joint inflammation and pain”

is deemed an implied disease claim for

the treatment of rheumatoid arthritis.


REGULATORY

Advertising Regulation of joint claims made in the advertising of products falls under FTC’s

general enforcement of Section 5 of the FTC Act and the Truth-in-Advertising Laws. Under the Truth-in-Advertising Laws, all advertising must be truthful, not deceptive or misleading, and substantiated.

Adequacy of substantiation and truthfulness are often evaluated together in determining whether an advertising claim is ultimately a legal claim. Advertisers must have adequate substantiation for all material claims and for health claims; the standard is “competent and reliable scientific evidence.” While FTC has indicated that the standard of “competent and reliable scientific evidence” may include tests, studies, research, analyses or other evidence based on the expertise of professionals in the relevant area, the specific level of evidence required by FTC often depends on the claims being made. Furthermore, if a company makes a statement that an ingredient or product is “clinically proven” to cause weight loss or “scientifically proven to increase the body’s metabolism,” the substantiation standard bar is raised, and evidence in the form of clinical studies or specific scientific research must be shown.

The scientific evidence offered to support claims must support the actual levels of ingredients contained in the products. Too often, specific studies are referenced or claims such as “clinically proven” are made when, in fact, the studies referenced do not support the particular level of ingredients or combination of ingredients. For example, a study that demonstrates the effectiveness of an ingredient at 1,000 mg/d does not substantiate claims for a product with that same ingredient at 200 mg/d. While not mandated, FTC generally prefers to see studies that demonstrate effectiveness for the particular combination of ingredients in a product, as opposed to studies on individual ingredients.

In its guidance titled “Miracle Health Claims,” FTC indicates there is “no shortage of people selling unproved arthritis remedies” and that such remedies “aren’t backed by science to demonstrate relief.” In 2014, FTC took action on an Arizona company for making allegedly unsupported claims to advertise a liquid dietary supplement. Claims for the prickly-pear fruit drink included that it would “relieve pain,” “reduce and relieve joint and muscle swelling,” and “alleviate respiratory problems.” As part of a settlement and consent order agreed to by the company and its principals, USD $3.5 million was forfeited for consumer refunds, and they may not make health claims without “competent and reliable scientific” evidence.

All advertising must be

truthful, not deceptive or

misleading, and substantiated.


REGULATORY

The 2014 action by FTC over pain and joint claims was by no means the first of its kind. In 2010, upon a referral from the National Advertising Division (NAD) of the Council of Better Business Bureaus, FTC initiated an investigation into a product marketed as a joint pain relief product for dogs and cats. FTC has also taken action against the marketer of a skin cream product touted to eliminate pain due to disabling joint conditions and the makers of a bracelet touted to relieve arthritis pain, joint pain, back pain and injury-related pain.

Ensuring ComplianceCompanies making joint health claims have not been immune to the wave of

class action litigation either. In particular, companies making claims pertaining to glucosamine and chondroitin have been on the receiving end of numerous class action lawsuits over the last several years, asserting that there is no evidence to support claims such as “help rebuild cartilage and lubricate joints,” “improves joint health,” and “less joint discomfort.” Such actions usually involve costly expenditures of time and money, and they also force companies to make difficult decisions. Whether attempting to ensure compliance with regulators or to avoid the prying eyes of plaintiff lawyers, companies must keep two fundamental principles in mind when making joint claims for non-drug products: Claims may not implicate the treatment of diseases, such as arthritis, and companies must have the proper substantiation to make claims. Failing to adhere to either may cause a whole different kind of pain. ¾

Justin J. Prochnow is an attorney and shareholder in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food and beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6562 or [email protected] and he can be followed on Twitter at @LawguyJP.

This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively.


Takeaways for Your Business

With people around the world living longer, plus an increased awareness of joint health’s importance starting at an early age, now is the prime time for

dietary supplement manufacturers to hone in on this evergreen market. Due to the complex need, many joint health ingredients target three main

areas—promoting healthy joint tissues, protecting against inflammation and relieving pain. In some cases, ingredients tackle all three mechanisms of action. Compounds such as curcumin and omega-3s are especially helpful for quelling inflammation in the joint structure.

While many joint health ingredients are certainly on the rise, as a whole, the sector had a less-than-stellar year in terms of U.S. sales during 2014. According to data collected by SPINS, which tracks sales of vitamins, supplements, herbs and homeopathics marketed for joint health (within the U.S. combined natural and conventional channels), the segment experienced an 11.6-percent decrease from December 2013 to November 2014 (USD $358.9 million to $317.4 million). Among the top primary ingredients across all channels, glucosamine/chondroitin combinations fell 16.7 percent ($246.6 million to $205.5 million), while chondroitin alone fell 26.9 percent ($3.0 million to $2.2 million). However, collagen products did experience an increase of 33.5 percent ($1.6 million to $2.1 million) and Boswellin or Boswellia also rose 56.5 percent ($1.2 million to $1.9 million).

Traditional ingredients for joint health—such as glucosamine and chondroitin—may have experienced decreased sales due to fact they’ve been “overplayed” in the market, according to Catherine Adams Hutt, Ph.D., RD, CFS, chief science and regulatory officer, Sloan Trends. She added that these ingredients are helpful for some of the population, but not all, due to studies showing they can help certain consumers with specific types of joint pain. The goal of effective ingredients, she said, should include anti-inflammation and maintenance of normal joint physiology. This means the market may see a rise in sulfur sources of MSM; S-Adenosyl methionine (SAMe); and anti-inflammatories such as boswellia, ginger and curcumin/turmeric

As various ingredients gain traction in the market, many products making joint claims have also found their way onto the radar of federal agencies tasked with regulating such claims, as well as plaintiff lawyers looking for their next class action lawsuit target. Ultimately, companies must keep two fundamental principles in mind when making joint claims for non-drug products: Claims may not implicate the treatment of diseases, such as arthritis, and companies must have the proper substantiation to make claims.

Understanding the regulatory landscape and keeping tabs on the most popular, research-backed ingredients can ensure a company’s success within the joint health market. ■

IN THIS ISSUE

Regulatory p. 16

INSIDER Contacts p. 21


TAKEAWAYS


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