HEALTH

Q&A: Scott Rudolph, CEO of Piping Rock Health Products

BY DSN STAFF

The vitamin and mineral category continues to be a high-growth business for retail pharmacy, with sales topping more than $6 billion annually. To get a handle on where the growth is coming from, what’s next and how his new company can help retailers fully leverage the opportunities in the space, Drug Store News recently caught up with Scott Rudolph, CEO of Piping Rock Health Products, makers of the Nature’s Truth brand of vitamins and supplements. Piping Rock may be a new company, but Rudolph and his team are definitely not newcomers to the VMS business, having helped to pioneer the category in the 1980s and 90s with the Nature’s Bounty brand. DSN talked to Rudolph this summer at Piping Rock’s Ronkonkoma, N.Y., offices to find out more about the new company and why experience matters in the VMS business. 
 
Drug Store News: Your leadership team has decades of experience in the VMS business — tell us a little bit about the history of the company. 
Scott Rudolph: We started Piping Rock Health Products about four years ago. More than a dozen members of my former senior management team joined me to help build the company. They have a vast array of skill sets and experience, including operations, manufacturing, production, sales, marketing, finance, product development and customer service.
 
DSN: Do you think the business is different today than it was in the past, either from a regulatory, consumer or a news media standpoint?
Rudolph: The regulatory environment is much more complex today and monitored more closely, with more frequent FDA audits. Quality and manufacturing standards are higher, and much more is required these days.
 
It is also more difficult to manufacture products today than it was 10 years ago — there are more rigid testing requirements and method validation, increased documentation and computer system requirements, including enhanced monitoring of raw material tracking, purity standards, GRAS requirements and more. Additionally, training and documentation to support qualified staffing is also more intense and more frequent than it once was.
 
[We believe that] regulation of our industry is important to ensure quality assurance and compliance; it is extremely important for regulators to continue to protect the consumer, ensuring both the quality of the product and truth in labeling.
 
At Piping Rock, we guarantee our manufacturing process is safe, clean and meet[s] or exceed[s] all of the U.S. Food and Drug Administration’s quality standards.
 
[That said], one area where government/regulatory action has had a negative impact on the category was the decision about four years ago to eliminate pretax eligibility for vitamins and supplements [under Flexible Savings Accounts].
 
Consumers are still looking for the next great trend in wellness — that really has not changed. They’re looking for quality product packaging and specific ingredient callouts like “standardized herbals,” “high ORAC values,” “gluten-free” and “preservative-free.”
 
The media has tried to be evenhanded, but they sometimes jump the gun before all the facts are in, and that makes retailers and manufacturers have to scramble to take a defensive position. Over the years, the media has reported both positively and negatively about the category. For example, about 10 years ago the negative press on vitamin E practically devastated the category, but the business bounced back. I believe it allowed other segments to grow like fish oil and Co Q-10, which are still top-trending heart health supplements today. A year and a half ago, we saw some softness from negative press around multivitamins; however, vitamin D remains a popular ingredient that continues to receive positive press and helps fuel industry growth. Interestingly, vitamin E was back in the news this year, and we have seen an uptick in sales from the positive press. 
 
DSN: Overall, IRI has the total VMS category up about 2%. Do you think VMS is a mature market, or do you think there is room to grow the business? 
Rudolph: I still believe there is a lot of room for growth, both from current users and new users. Baby boomers are still coming into the market, and they’re living longer — people in their 70s and 80s take substantially more supplements than people in their 40s and 50s. When a life event occurs, consumers tend to enter a specific supplement category as a proactive approach to their health and wellness; society is becoming more results-driven. So, products that deliver results, where consumers can see or feel the difference, is where, I believe, the growth in the category will continue to come from — particularly in such areas as sleep, energy, beauty and probiotics.
 
New products that enhance wellness help fuel trial and category growth. The media can also help influence purchasing decisions, as well.
  
There are always new ingredients coming to market. The vitamin industry is like the fashion industry that way — trends come and go. Some of the new ingredients that are hot right now are turmeric, tart cherry and matcha green tea. 
 
We monitor consumer data daily on our Piping Rock website and can see trends emerge early on. We are also able to react quickly and create a testing platform for new products, including new ingredients, higher potencies, and various delivery forms.
 
DSN: What do you think the big trends are right now in the natural health space — and what's coming next? Do you think retailers are fully leveraging those opportunities?
Rudolph: Enhanced delivery systems will continue to fuel growth as consumers experience pill fatigue. Alternative delivery forms that enhance consumer satisfaction and ease of swallowing — such as gummies, fast-dissolves and sublingual liquids — are also top-growth drivers right now. 
 
Women’s wellness doesn’t just refer to [products for] internal [use], but external, as well. For instance, a woman’s overall wellness regimen includes products that cross into the beauty aisle, such as hair, skin and nails formulas and Biotin supplements. We are seeing more crossover categories that are expanding the vitamin customer’s basket.
 
One of the biggest trends emerging in wellness right now is aromatherapy … consumers are using it to complement their nutritional supplementation based on their specific wellness needs — for example, the soothing aroma of lavender and the cooling feel of eucalyptus. The aromatherapy market has seen continued, exponential growth. I see this as the next big incremental opportunity for retailers in the VMS category — offering aromatherapy items supports a total wellness approach. We sell more than 125 different aromatherapy items on PipingRock.com and just launched a line featuring our top 16 items for [our] Nature’s Truth [brand]. All of our oils — including fragrant essential oils and base oils — are 100% pure and are derived from 100% all-natural plant sources, such as flowers, fruits and herbs to help stimulate the senses. 
 
Some retailers are further ahead of the curve than others and are starting to look at their VMS section, treating it more like a “wellness destination” to improve the customer experience. I expect to see greater and greater acceptance of this approach. Some retailers move more quickly than others in order to stay current with emerging trends. I feel those who embrace change early really benefit most and are able to capture the most market share.
 
DSN: What should retailers know about your company and the brand — how is Nature's Truth different?
Rudolph: Piping Rock Health Products launched the Nature’s Truth brand in 2014. Given the opportunities that I see in the market with leveraging insights from our PipingRock.com business — including consumer movement, product demands, requests, complaints, reviews and emerging trends — we can bring hot items to market very quickly. 
 
[We are fully vertically] integrated, performing in-house what other manufacturers outsource. By doing everything in our own facilities, we are able to accelerate production and guarantee quality. We [even] print our own labels in-house, so [we] can produce and ship products the very next day.
 
We have over 1,200 unique items on PipingRock.com, which allows us to quickly bring hot new products to market, because we already have the formulas and the products established. Speed is important in our business. As I mentioned before, the vitamins and nutritional supplement category can be very trendy, so being able to align the right products with consumer demand at the right time is essential.
 
Our team’s decades’ of experience and knowledge in the category enables us to advise retailers on the products they should be stocking and how to promote to meet their customers’ needs.
 
DSN: What is the main entry point for consumers seeking a VMS product for the first time? Multivitamins? Or are they coming to the category looking for a specific supplement? 
Rudolph: Multivitamins still remain a leading entry point for first-time consumers, but that influence is lessening. Multivitamins once represented almost 28% to 30% of category sales, but it is now down to about 25%, according to the latest 13-week data through May from IRI.
 
Millennials and Generation-Xers are not just entering the category through multivitamins; they are also entering through specific supplement categories, such as sleep with melatonin and energy with B-12 vitamins. Additionally, aromatherapy and beauty supplements are bringing new consumers into the category. Those who are entering the category through multivitamins are leaning more towards gummies, which [are] an extremely fast-growing delivery system.
 
DSN: How important is social media in a category like VMS, and how is Nature's Truth using social media to drive awareness for the brand and the importance of VMS and nutrition?
Rudolph: The Internet, including social media, is definitely growing in influence. The longtime influence of friends and family is still very prominent, but social media allows for personal recommendations and influences to multiply rather quickly. Consumers are looking to the Internet to help support their purchase decision before they shop. So stocking top-trending items and offering a wide selection is important to satisfying the customer.
 
At Nature’s Truth, we promote heavily in social media and are engaging brand advocates to truthfully discuss our products and their experience with our brand to help spread awareness.
 
This fall, we are launching our Honestly Good Challenge via social media as a way to engage consumers and introduce the Nature’s Truth brand. The Honestly Good Challenge is an interactive program to help support consumers’ wellness goals for 30 days, and if they are not satisfied with our products, we will refund [their purchase]. We take our brand seriously and 100% guarantee the satisfaction of our products. Simply put, we want consumers to know and trust our brand and to stand by the quality of our products as much as we do.
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FDA issues final guidance on liquid pediatric acetaminophen

BY Michael Johnsen

WASHINGTON – The Food and Drug Administration on Wednesday published a final guidance regarding pediatric oral liquid OTC products containing acetaminophen to address ongoing concerns about the potential for acetaminophen overdose associated with these products and to promote their safe use.
 
Under the final guidance,  all single-ingredient acetaminophen oral liquids for pediatric use should have a concentration of 160 mg acetaminophen per 5 mL. In addition, the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented on the principal display panel of the container label and carton labeling immediately below or to the right of the active ingredient name (i.e., acetaminophen) and in the same font size as the active ingredient name. Dosing directions should be provided only in mL. 
 
The guidance also directed marketers that any recommended use age range should reflect the same age range as stated in the Drug Facts Panel under the heading "Directions" and any images of children on the carton should also be representative of the age group identified under "Directions."
 
The product package should include an appropriate dosage delivery device using units of mL, such as a calibrated and labeled oral syringe or dosing cup, a picture of which should be on the packaging. 
 
Many of these provisions have already been voluntarily adopted by consumer healthcare companies. Last fall the Consumer Healthcare Products Association announced several key changes in marketing pediatric acetaminophen products, namely: 
 
  • Deleting “spoon” labeling (i.e., teaspoon, tablespoon) on dosing directions and dosing devices;
  • Specifying use of “mL” only in dosing directions and on devices; and
  • Deleting the provision in dosing directions of a definition of any volumetric unit of measure (i.e., mL = milliliter).
 
“The makers of OTC medicines fully support using mL as the standard unit of measurement on all liquid orally ingested OTC medicines for children, as we believe this uniformity will make proper dosing easier for parents,” stated Scott Melville, CHPA president and CEO, at the time of the fall announcement. “We know from recent a study released in Pediatrics that parents who used milliliter-only units made fewer dosing errors than those who used teaspoon or tablespoon units. We hope this change combined with the ongoing educational efforts of the CHPA Educational Foundation will contribute to a significant decline in medication errors.”
 
 
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FDA bans 3 VMS companies from manufacturing

BY Michael Johnsen

SILVER SPRING, Md. – Three dietary supplement companies, under the same ownership and located in Wautoma, Wis., will not be allowed to manufacture or sell dietary supplement products until the Food and Drug Administration has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.
 
U.S. District Judge William Griesbach for the Eastern District of Wisconsin entered a consent decree of permanent injunction against Atrium, Aspen Group, Nutri-Pak of Wisconsin and their owners, James and Roberta Sommers.
 
The complaint, filed by the U.S. Department of Justice, alleges that U.S. Food and Drug Administration inspections of Atrium, Aspen and Nutri-Pak found numerous violations of the agency’s current Good Manufacturing Practice regulations, including failure to properly identify ingredients used in certain dietary supplements, failure to qualify suppliers and failure to properly manufacture and label dietary supplements. The complaint also alleges that these violations caused the companies’ dietary supplements to be misbranded and adulterated under the Federal Food, Drug and Cosmetic Act.
 
Dietary supplements manufactured by the businesses include Atrium brands Chole-Sterin, Di-Acid Stim, Ocu-Comp, and Super-Flex; Aspen brand Flexile-Plus; and Nutri-Pak brands Glucobiotic Supreme and Ocu-Comp.
 
The FDA issued Atrium a Warning Letter  on Nov. 2, 2012, citing the company for failure to follow the FDA’s current Good Manufacturing Practice regulations for dietary supplements. Follow-up inspections of Atrium, Aspen Group and Nutri-Pak of Wisconsin in 2013 and 2014 found continued violations.  
 
“When companies violate good manufacturing practice requirements, they put consumers at risk,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “Our goal at the FDA is to protect public health by ensuring that dietary supplements are manufactured, labeled and distributed in accordance with federal regulations.”
 
The consent decree requires the defendants to destroy all dietary supplements in their possession under supervision from the FDA. Before the companies can resume making or selling dietary supplements, they must hire an independent expert and defendants may not resume operations until they receive permission to do so from the FDA.
 
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