Despite a barrage of negative publicity that reached a pinnacle in February 2015 with the New York Attorney General investigation of botanical dietary supplements sold at GNC, Target, Walgreens and Walmart, the industry overall still seems to be on strong footing, according to sales data, consumer surveys and expert analysis. However, future success will likely require a renewed commitment to quality and strong standards for safety and traceability.

More than two-thirds (68%) of U.S. adults take dietary supplements, which has been consistent over the past five years, according to the 2015 Council for Responsible Nutrition (CRN) Consumer Survey, an analysis conducted annually since 2000.

Overall, confidence in the safety, quality and effectiveness of dietary supplements has also remained stable over the past five years, at 84% in 2015. Usage was highest, and confidence was strongest, in the vitamin and mineral category; among supplement users, 78% reported taking a multivitamin, 32% vitamin D, 27% vitamin C, 24% calcium and 18% B vitamins.

Regular usage of a variety of supplements seems to increase with age, and women overall take more supplements than men, however, that division is narrowing. The CRN survey found similar percentages of overall usage between men and women of younger generations. There appear to be larger gaps in usage between men and women of older generations.

In 2015, men of all ages were equally likely to use supplements, while it seems usage among those age 55+ has dropped somewhat, perhaps due to confusion from conflicting information and negative reports in the media about safety and efficacy of certain supplements. However, strong usage among Millennials is a good sign for the industry’s future.

Data from SPINS show that sales of vitamins and dietary supplements grew 2.9% to about $11.65 billion for the 52 weeks ending Jan. 24, 2016 in the combined natural (excluding Whole Foods), specialty supermarkets and conventional multi-outlet (including Wal-Mart) channels. Sales of vitamin and mineral supplements alone grew 2.8% to $3.86 billion during that same period, according to SPINS.

Sales of herbal dietary supplements in the U.S. increased by 6.8% in 2014, reaching an estimated total of more than $6.4 billion, according to data published in HerbalGram last year based on statistics from Nutrition Business Journal, SPINS and IRI.

The Notorious NY AG
New York Attorney General (NY AG) Eric Schneiderman’s investigation into herbal dietary supplements has ignited debate within and about the industry—to a level that hasn’t been equaled since the period before the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994.

While the discredited investigation hinged on DNA barcode testing that was misapplied to finished botanical extracts, many media outlets ran with a story that portrayed the broader industry as unregulated and potentially dangerous.

According to Michael Archbold, CEO of GNC Holdings, Inc., Pittsburgh, PA, the investigation and corresponding negative media attention has served to undermine consumer confidence, which could erode the industry over time.

GNC was ultimately vindicated after results from third-party testing confirmed its herbal supplement products are safe, pure, properly labeled and in full compliance with regulatory requirements. However, the company reached an agreement with the NY AG’s office whereby GNC will begin utilizing DNA barcode testing to confirm the authenticity of all plants used as sources for its herbal supplements prior to processing.

“DNA barcoding is not a panacea,” Mr. Archbold confirmed. “It is simply another arrow in the quiver. It’s another tool for us to use to make sure that we can create seed-to-shelf traceability.” The company continues to utilize other analytical tests as well, including high performance liquid chromatography, high performance thin layer chromatography, mass spectrometry and others.

Industry Initiatives
GNC also recently adopted draft guidelines for botanical raw material GMPs that were developed by a coalition of experts and industry leaders. “We are creating a uniform set of standards,” said Mr. Archbold. “We have a lot of great suppliers out there who are doing the right thing, but they’re doing it differently from each other. The botanical GMPs really create a standard to say what it is that we can all agree we should be doing.”

Stakeholders in the supplement industry have come together to align around the changes, he added. “Major players, former FDA auditors, former TGA auditors, expert botanists and analytical chemists have all given their feedback and had their comments incorporated into this guideline,” Mr. Archbold said of the current draft that GNC has adopted. “This is really putting in one place what we believe those best practices are.”

The intent of the guidelines is to continue improving processes and protocols to ensure safety, quality purity and potency. Adopting standards so that companies abide by the same procedures going forward for identity and testing of raw materials, for example, will benefit the industry and consumers, he added.

Obviously consumer trust in supplement brands is vital for the industry’s long-term success. With that goal in mind, GNC wants to have full visibility of the chain of custody “from the seed to the shelf.” Developing the appropriate testing standards for identity, purity, potency and quality, at every step through the process, will help ensure that traceability.

Mr. Archbold said it’s his expectation that these guidelines, once finalized, could serve as a strong standard for other companies to adopt. “I think the industry is best served by having experts put together the best practices and codify them.”

He went on to suggest product safety and quality in the dietary supplement industry overall is “excellent,” and only continues to improve. Indeed, responsible companies have emphasized the importance of GMP standards and properly auditing suppliers and vendors, as mandated by federal law. A few bad actors “should not impugn the reputation of the many great quality players that are out there,” he said.

Still, it’s important to continue developing and implementing higher and better standards. “We’ve always been an industry that has continuously improved processes.”

As a next step, GNC and others in the coalition are working to develop audit standards associated with the botanical raw material GMPs. Additionally, as a sign of transparency, creating a dietary supplement product database will help to give regulators essential information and better visibility into the industry.

“These are some of the natural next steps that we are taking collectively,” said Mr. Archbold.

CRN has taken a lead in terms of transparency, requiring that all its members, as a condition of membership, submit supplement product labels to the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) Dietary Supplement Label Database (DSLD).

The mandatory requirement applies to those CRN member companies listed as the responsible party on the product label for all dietary supplement products marketed in the U.S.

In announcing the board’s policy adoption, CRN President and CEO Steve Mister stated, “This marks the start of a new era for our industry. Our members can no longer allow those companies skirting the laws to tarnish our reputation. This first step toward greater transparency for regulators and researchers is long overdue, and we strongly urge others in the industry to work with us on this and future initiatives that will ultimately build a stronger industry.”

Last year, CRN’s members formed a Product Transparency Working Group to address ways the association and the industry could better assist regulators in their efforts to police the industry and protect the public. After evaluating the various options for establishing a more accurate registry of dietary supplements, based on the research of this working group, the CRN Board selected the ODS DSLD as the most appropriate place to start this project.

Communication and education is also an important element of the industry’s response to actions taken by state attorneys general, a coalition of whom petitioned Congress last year to expand FDA’s powers to regulate the industry.

In an effort to ensure they have an accurate understanding of the industry, the American Herbal Products Association (AHPA) and the United Natural Products Alliance (UNPA) launched a joint campaign to develop working relationships with state AGs and educate them about the herbal supplement industry.

The associations hired the Washington, D.C.-based law firm BuckleySandler and attorney Douglas Gansler to help deliver information and expertise about the industry to state AGs. Mr. Gansler was the attorney general of Maryland from 2006-2014 and is the most recent past president of the National Association of Attorneys General.

The campaign seeks to build positive, collaborative relationships with state AGs, their office and staff while providing resources in support of responsible industry and to create industry advocates. The goal ultimately is to shift the focus of state AG regulatory efforts toward unsafe and adulterated products that are falsely labeled as supplements and also educate state AGs about responsible industry and the economic significance of supplement companies.

Federal Focus
State AGs haven’t been alone in their focus on the dietary supplement category. In November 2015, as part of a coordinated sweep, the U.S. Department of Justice and federal partners pursued civil and criminal cases against more than 100 manufacturers and marketers of allegedly illegal products sold as dietary supplements.

The actions resulted from a yearlong effort to focus enforcement resources on products that don’t meet standards for supplements and have been a cause for concern among health officials. In each case, the department or one of its federal partners alleged companies were selling products that contained ingredients other than those listed on the label, or products that made disease treatment claims that were unsupported by adequate scientific evidence. During the period of the sweep, 117 individuals and entities were pursued through criminal and civil enforcement actions.

Industry groups that have continuously called for greater regulatory enforcement praised the actions against companies that violate federal laws.

Daniel Fabricant, PhD, executive director and CEO of the Natural Products Association (NPA), said it’s encouraging to see FDA taking action against select companies that “seem to have no interest in GMP compliance.”

While the overall percentage of those companies in the industry appears to be getting smaller, Dr. Fabricant said there are still firms that don’t have any specifications for identity, strength, potency and purity, as evidenced by FDA Warning Letters that have been issued.

Further demonstrating a commitment to overseeing the supplement industry, the FDA created an Office of Dietary Supplement Programs (ODSP), elevating the group from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements. The reorganization is expected to enhance the effectiveness of dietary supplement regulation.

The Office of Dietary Supplements Programs will utilize its authority and resources to monitor the safety of dietary supplement products by continuing to remove dangerous products from the market, including those falsely labeled as dietary supplements that contain potentially harmful pharmaceutical agents.

The office will also enforce GMPs, giving priority to cases in which violations potentially compromise product safety, fail to ensure product identity and result in consumer deception.

In addition, the agency will take action against claims in cases involving serious risk to consumers, such as egregious disease claims, or widespread economic fraud.

On an advocacy front, with the retirement of Senator Tom Harkin (D-IA) and the pending retirement of Senator Orrin Hatch (R-UT), both long-time champions of the dietary supplement industry, trade groups have been actively talking with Congressional representatives to communicate the value and importance of their members’ products. 

Additionally, seen as what could be an important legislative milestone, in February this year Senator Hatch and Representative Erik Paulsen (R-MN), introduced the Health Care Savings Act (S. 2499 and H.R. 4469), which would allow consumers to use Health Savings Account (HSA) and Flexible Spending Account (FSA) dollars on dietary supplements.  

Dr. Fabricant said the legislation would effectively make dietary supplements tax-free as a recognized mechanism to support health and wellness. Calling it a “vitally important” piece of legislation, he urged stakeholders to contact their representatives to support the measure.

Continuous Improvement
For those companies that aim to improve their manufacturing operations, certain aspects of the GMP regulation can be a challenge. According to Dr. Fabricant, who previously served as director of the Division of Dietary Supplement Programs at FDA for more than three years, the agency is going to look for required documentation as a starting point.

“After that, they’re going to start going through those documents and what they mean to your manufacturing. So, do you have them, are you following them and then what do they mean? What type of data do they provide on your continuous improvement? Are they backing your assertion that my quality systems are helping make my product better?”

While much focus of late has been on testing practices, “you can’t just test quality in at the end,” Dr. Fabricant noted. Specifications need to be set in a way that the company can account for every control point throughout the manufacturing process. “That’s an art people have to learn, and a big part of our role in terms of certification and education.”

Still, supplement manufacturers need to make sure their process works, “and the only way to do that is by testing it,” said Dr. Fabricant. “It’s critical in the era of GMPs. You need to have the right tests for the job. You need to make sure it’s specific to your process and fit for purpose. Testing needs to be in line with the intended use of the product and the quality parameters around the product. If the testing doesn’t measure those quality parameters based on scientific principles it’s going to be tough to be GMP compliant.”

In an effort to further educate companies and foster GMP certification, last year NPA partnered with UL (Underwriters Laboratories), an independent safety science company that offers quality assurance solutions ranging from raw material and finished product testing to manufacturing audits and quality inspections. UL has undergone an accreditation process for its programs through the American National Standards Institute’s (ANSI) National Accreditation Board (ANAB) to validate standards and procedures.

Mike O’Hara, the general manager of the global nutraceuticals business for UL, said there’s a clear focus on continuously improving the joint certification program between NPA and UL, for example, through evaluating auditors, checklists, guidance, training, etc. “How do we improve our program to ensure our customers are confident in their quality systems going forward?”

The company collects and reviews data to assess the work of its auditors to ensure companies understand the regulations, as well as the reasons certain elements are in place, so they can make sound judgments, Mr. O’Hara said.

Companies seem to recognize the industry is at an important moment, with regulators, media and consumers all paying closer attention to the marketplace. A renewed and focused commitment to quality aligns with UL’s history and brand, said Mr. O’Hara.

Last year UL launched its ClearView program, a web application designed to provide transparency and a structured process to register products and quality data. The platform allows companies to enter their formula along with GMP audit results, testing data and other quality assurance information.

That level of visibility is important to helping companies demonstrate that their products conform to recognized quality parameters, said Mr. O’Hara, and allows retailers to make informed buying decisions. “The industry needs to know what’s on the market.”

The registration program has been positively received overall, he added. “There are always people hesitant to change. I think that happens no matter what you’re doing. In this era, where information is becoming a critical factor in decisions people make, for the industry to get out in front and build this out makes a ton of sense.”

Overall, NPA and UL are focused on affecting positive change within the industry by developing new solutions, tactics and strategies, Mr. O’Hara noted. “The industry is trying to help people live healthier lives and that’s what UL is all about—working for consumers and protecting the public.”