Meeting the Demand for Quality Dietary Supplements

Meeting the Demand for Quality Dietary Supplements Meeting the Demand for Quality Dietary Supplements Meeting the Demand for Quality Dietary Supple...
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Meeting the Demand for Quality Dietary Supplements

Meeting the Demand for Quality Dietary Supplements

Meeting the Demand for Quality Dietary Supplements The promise of improved physical and mental health has helped drive interest in dietary supplement products here in the U.S. as well as in other established and emerging

economies around the world. From food additives to vitamins and minerals, dietary

supplements are becoming an essential component in the daily diet of many healthconscious consumers, providing important nutritional balance and helping them

to better deal with age-related physical and mental conditions. As healthcare costs

continue to escalate, some consumers are even relying on dietary supplements as an alternative to traditional medical treatments.1

In the U.S., most dietary supplements are classified as food by the U.S. Food and Drug Administration (FDA), and are beyond the same rigorous oversight as prescription

drugs and over the counter medications. Unfortunately, the FDA has received more than 10,000 reports of adverse reactions to dietary supplements during the period

between 2008 and 2013.2 In addition, the FDA estimates that about 70% of nutritional supplement manufacturers have failed to follow FDA-mandated good manufacturing practices during that same period.3 These and other concerns have raised the level of scrutiny of dietary supplements by regulators and consumers alike.

This UL white paper discusses how manufacturers can meet consumer demand for quality dietary supplements while reducing the risks associated with unexpected

adverse reactions and product recalls. The paper begins with a brief overview of the dietary supplement marketplace and a summary of the regulations applicable to

dietary supplements in the U.S. The paper then discusses the primary health and safety concerns about dietary supplements among consumers, and the potential risks to

manufacturers and retailers whose products fail to meet regulatory requirements or consumer expectations. The white paper proposes a multi-step preventative action

plan for dietary supplement manufacturers and retailers, and identifies the potential benefits of such an approach.

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Meeting the Demand for Quality Dietary Supplements

What Are Dietary Supplements? The term dietary supplement is generally used to describe any product taken by mouth that contains an ingredient or ingredients specifically intended to

supplement a diet. Dietary supplement

products come in a variety of forms, such as vitamin and mineral products, herbal

nearly $23 billion (USD) in the U.S. in 2012,

supplements often deviates

approximately 4%.5 More than 85,000

a product’s label. For example,

currently available in the U.S, and more

44 different herbal products

takes one or more dietary supplements,

and Canada found that 32% of

multimineral products.

contained none of the herbal

with future annual growth projected at dietary supplement products are 6

ingredients in supplement products can include vitamins and minerals, herbs and other botanical ingredients, and

substances such as amino acids, enzymes and metabolites in concentrated or extract form.

Research by McKinsey & Company places

the global value of the market for dietary

supplements, including vitamins, minerals and nutritional supplements, at $82

billion (USD) annually. Equally important, the future growth in the market for

dietary supplements is expected remain strong, growing between 5-6% per year through 2017. These growth prospects

reportedly reflect the increase in healthconscious consumers as well as aging populations in the U.S., the European Union and Japan. 4

By most accounts, the U.S. market for dietary supplements is the largest in

total size and in the number of dietary

supplement product offerings. According to a separate report by Euromonitor International, the sale of vitamins,

minerals and supplements reached

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Canadian researchers evaluating

than half of the U.S. population regularly

commercially available in the U.S.

primarily in the form of multivitamin and

samples subject to DNA evaluation

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supplements, and specialized nutritional products like protein powders. Dietary

from the composition stated on

ingredient listed on the label,

while 59% of samples contained

Health and Safety-Related Concerns about Dietary Supplements

plant species that were completely omitted from the label.8

•  Quantity of ingredients—In

Despite consumers’ general acceptance

addition, quantities of listed

benefits, dietary supplement products

the amounts stated on a product’s

of their potential health and nutritional sold in the U.S. are not required to be independently tested for safety or

efficacy prior to being placed on the

market. Instead, manufacturers are solely responsible for evaluating the safety

and proper labeling of their products for compliance with FDA regulations.

Although the vast majority of dietary

supplements on the market are safe, the FDA receives thousands of consumer

complaints and adverse reaction reports every year in connection with dietary supplements. In addition, there have

been multiple independent reports and

studies pointing to potentially significant

health and safety issues related to dietary

supplements on the market. Most of these issues can be categorized as follows:

•  Product composition—The actual ingredient composition of dietary

ingredients can vary widely from label, exposing consumers to

unsafe levels of certain ingredients. In one study, researchers linked

cases acute selenium toxicity in

over 200 patients to a liquid dietary supplement that contained 200

times the selenium concentration listed on the supplement’s label.9 •  Safety of ingredients—In some

cases, dietary supplements contain toxic metals and other potentially harmful ingredients. In a widely publicized study, researchers

determined that more than 20% of

ayurvedic medicines sold in the U.S.

via the Internet included detectable levels of lead, mercury or arsenic in excess of daily intake standards.10 In a separate instance, an FDA

laboratory analysis determined that a product marketed as a

vitamin B dietary supplement

Meeting the Demand for Quality Dietary Supplements

actually contained two potentially

ingredients found in dietary supplements.

Registered food facilities are subject to

omitted from the label. One of the

are outside of the strict oversight

and registration can be suspended in

harmful anabolic steroids that were two steroids, methasterone, is a

Schedule III controlled substance in the U.S.11

•  Product-related health claims— Finally, some manufacturers

promote dietary supplements

by making false or exaggerated claims regarding health-related

benefits associated with the use

of their products. For example, an

Arizona-based company marketed liquid homeopathic drops as a

weight-loss dietary supplement

that the company falsely claimed would help consumers achieve

rapid and significant weight loss.12 These and other quality and safety issues

related to dietary supplements have raised legitimate concerns among consumers, and have prompted many retailers to

establish quality and safety requirements within their existing procurement

practices. This practice can be especially important when a retailer is sourcing

dietary supplement products to be labeled and sold under the retailer’s proprietary

brand, since the retailer would be directly implicated in cases of quality and safety issues related to their products.

As previously noted, dietary supplements accorded drugs and pharmaceutical

products. Instead, they are categorized as a type of food product, and must comply with regulations promulgated under the federal Dietary Supplement Health and

Education Act (DSHEA) of 1994 and other more recent legislation.

a given facility is responsible for a food product with a reasonable probability of causing serious adverse health

consequences or death to humans or

animals. Food facility registration must be renewed every other year.13 Adoption of Good

directly responsible for evaluating the

As of June 2010, all companies that

prior to marketing them for sale, and

finished dietary supplement products

that are adulterated or misbranded. The

regarding good manufacturing

responsibility for proving that a dietary

supplements. In brief, compliance with

unreasonable risk of illness or injury, or

requirements and/or activities:

manufacturers and distributors are

Manufacturing Practices

safety and labeling of their products

manufacturer, package, hold or distribute

are prohibited from marketing products

must comply with the FDA’s requirements

regulations also place with the FDA the

practices (GMPs) specifically for dietary

supplement presents a significant or

GMP provisions involves the following

contains an ingredient or other substance that could be injurious to human health.

•  Establishing and following

written procedures for physical

Although dietary supplement

plant sanitation, manufacturing

relatively limited regulatory oversight,

functions, laboratory testing,

products themselves are subject to manufacturers, importers and

distributors of dietary supplements are

still responsible for meeting a number of FDA requirements. These requirements

are described in the sections that follow.

Regardless of where they are located,

Regulatory Oversight of Dietary Supplements, Dietary Supplement Manufacturers

manufacturers of dietary supplement

In the U.S., the FDA regulates both

processes, packs or holds food for human

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cases where the FDA determines that

Under current FDA regulations,

Registration of Food Facilities

finished dietary supplement products and

periodic inspection by FDA personnel,

products must register their production

facilities with the FDA. This requirement

applies to any facility that manufacturers, or animal consumption in the U.S.

operations, quality control

packaging and labeling, and product complaints

•  Establishing and maintaining

written master manufacturing records and batch production records

•  Establishing production

and process control system specifications

•  Establishing and maintaining quality control systems and procedures

Meeting the Demand for Quality Dietary Supplements

•  Conducting identity testing of

dietary ingredients as well as a sample of finished products to

assess whether they meet product specifications

In meeting the above minimum

Notification Process for

and distributors must make sure that

“New dietary ingredients” are ingredients

information requirements, manufacturers any and all information and/or product

claims that appear on the product label are truthful and not misleading. It is 15

The GMP requirement for dietary

supplement products applies to all

domestic and foreign countries that

manufacture, package, label or hold dietary supplements, and is also

applicable to those entities involved

in testing, quality control, packaging, labeling and distribution activities.14 Labeling Requirements

The FDA also regulates dietary

supplement labels, package inserts

and other product literature that may accompany a dietary supplement.

Regarding labeling, the FDA requires

that dietary supplement product labels include, at a minimum, the following information:

•  A “statement of identity,” that is, the name of the dietary supplement

•  The “net quantity of contents,” that is, the amount of the supplement contained in the package

•  Nutrition labeling, also referred to as “Supplement Facts”

•  A list of all ingredients contained in the supplement

•  A U.S. phone number or complete U.S. mailing address that allows

consumers to notify the company

in case of a serious adverse event.

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also important to note that, in addition

to FDA labeling requirements for dietary supplements, the U.S. Federal Trade

Commission (FTC) has oversight over

the advertising of dietary supplements.

FTC regulations address the truthfulness of claims made in advertising and

New Dietary Ingredients

that were used in any dietary supplement marketed in the U.S. in 1994 or later.

Manufacturers and distributors who wish to market dietary supplement

products with any such ingredient must first provide the FDA with a premarket notification at least 75 days before the product is introduced into interstate commerce in the U.S.

other promotional materials for dietary

The premarket notification for a product

regulations.

must contain information about the

Recording and Reporting

other information demonstrating that

supplements, and are in addition to FDA

of Adverse Events

Under FDA regulations, manufacturers, distributors and retailers of dietary

supplements are required to maintain

records and reports of all adverse events related to their products. These records

are subject to inspection by FDA officials upon request. In addition, companies

distributing or offering for sale dietary supplements are required to report to the FDA any information they receive

regarding all serious adverse events. To

facilitate this required reporting process,

containing a new dietary ingredient ingredient, along with evidence or

the supplement containing the new

ingredient will generally be safe when used in a manner consistent with the

information accompanying the dietary supplement. Although the FDA does not currently prescribe the specific

information required, it recommends

that manufacturers conduct a thorough

search of available scientific literature for evidence of safety and for any adverse effects associated with the use of the ingredient.16

the FDA has recently initiated a new

Internet-based reporting mechanism

that allows companies to file adverse

event reports online. Finally, as previously noted, FDA regulations require that labels on dietary supplement products include

information that can facilitate the prompt and efficient reporting of serious adverse events associated with a specific dietary supplement.

The Cost of Noncompliance Given the dramatic increase in adverse events reported to the agency,

the FDA has recently stepped up

inspection activities in connection with dietary supplement manufacturers and distributors. According to one

independent analysis of FDA records, 444 of 626 inspections of GMPs at

Meeting the Demand for Quality Dietary Supplements

dietary supplement manufacturing or

unsubstantiated, false or misleading. The

of their source. Such a program

2010 through 2012 produced a finding of

injunction that will prevent it from

batch checks to assure product

distribution facilities conducted from

possible violations of FDA regulations. The same analysis indicated that, during 2012, 116 dietary supplement firms received a

warning letter, citing anywhere from two

company is now bound by a permanent

marketing or selling dietary supplements in the future.20

As the above cases illustrate, the cost

to 58 separate violations.

of noncompliance can lead to dire

In recent years, the FDA has also initiated

manufacturers of dietary supplements.

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legal action against several dietary

supplement makers for violations of GMP regulations and for the misbranding of products. In one case, the FDA issued a permanent injunction against a

Pennsylvania-based dietary supplement manufacturer for its failure to comply with GMP requirements, and for

failing to report serious adverse events

regulatory and legal consequences for

Of course, even for those manufacturers who eventually prevail in such cases,

unwanted publicity can adversely impact the public image of a company and

its products with consumers. This can

result in reduced demand for otherwise legitimate and helpful products, and place a company at risk.

to cease production and distribution of more than 400 dietary supplements.

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In a separate case, U.S. marshals seized dietary supplements produced by a

Wisconsin manufacturer that made

false claims regarding the safety and

effectiveness of its dietary supplements in treating a number of diseases. The

action followed multiple inspections of

the company’s facilities by FDA inspectors that uncovered numerous violations of the FDA regulations.19

Aside from the consequences for

noncompliance with FDA requirements, manufacturers may also be subject

to private legal action and more. For example, in a civil enforcement case

settled in early 2014, an Ohio company

agreed to pay nearly $1.8 million (USD) for promoting its line of dietary supplements based on health claims that were page 6

quality and periodic independent testing of ingredients.

•  Good manufacturing practices— FDA regulations requires all

manufacturers, distributors,

packagers or holders of dietary

supplements to implement and

maintain GMPs. But more than a regulatory requirement, a good

GMP program can help a producer to achieve production efficiencies that can improve overall product quality and even reduce production costs. •  Product testing—Production

processes should incorporate raw

connected with the company’s products. The injunction required the producer

can include random factory audits,

Action Plan for Dietary Supplement Manufacturers The most successful programs for

compliance with FDA’s regulations for dietary supplements usually involve a multi-step approach involving every

aspect of a producer’s operation, from raw material sourcing to final product validation. Here are some of the key

aspects of an effective compliance plan for dietary supplement manufacturers and distributors:

•  Sourcing of quality materials— Quality dietary supplement products start with quality ingredients and materials.

Manufacturers should establish a

responsible sourcing program that assures the quality and purity of

the raw materials used, regardless

material and finished product

testing to assess whether product specifications are being achieved and to quickly identify potential production challenges. Such

testing can assess microbiological, analytical or physical qualities of raw materials and finished products as well as possible contamination.

•  Information management—A

robust information management system is a critical tool to assure the retention of important data

and other records and to facilitate the creation of meaningful reports. It also provides

evidence of compliance with

FDA GMP requirements related

to documentation. Detailed and well-organized data may also

address retailer requirements for

Meeting the Demand for Quality Dietary Supplements

evidence of quality and safety in product production.

•  Independent validation testing—

consumers alike with assurances

regarding the quality, purity and safety of their dietary products.

The best compliance programs rely on the use of independent third

Conclusion

product content and to verify the

The U.S. market for dietary supplement

In addition, product packaging

more than 85,000 different products

of a qualified third party can

Unfortunately, quality and safety issues

regarding the quality and integrity

number of adverse events and product

parties to periodically confirm

absence of any harmful substances.

products is highly competitive with

that displays the validation mark

currently available to consumers.

provide consumers with assurances

are a significant concern, with a growing

of a dietary supplement.

recalls resulting in increased negative

•  Employee training—Finally, an

publicity for the industry and greater

scrutiny by the FDA and other regulators.

effective regulatory compliance

Manufacturers can reduce their risk and

commitment to employee

retailers and consumers by taking specific

commitment to training means

their dietary supplement products.

understand the reasons for specific

With over 50 years of in-depth dietary

greater appreciation for their role in

helps manufacturers and retailers meet

program requires an ongoing

strengthen their market position with

education and training. A

steps to assure the quality and safety of

that employees are more likely to

policies and activities and to have a

supplement knowledge and expertise, UL

producing safe, quality products.

the demand for high-quality, safe and

Manufacturers of dietary supplements

test methods to determine the quality

other initiatives are not only better

addition, UL can help clients implement

with FDA requirements. They are also

programs, including independent audits

effective products. UL uses recognized

who proactively implement these and

and integrity of dietary supplements. In

positioned to achieve compliance

and maintain effective quality assurance

more likely to reduce the incidence

to maintain supply chain integrity.

associated with their products. In doing

For additional information about

their position in a highly competitive

services for dietary supplements, contact

of adverse events and product recalls so, manufacturers can strengthen

UL’s testing, verification and auditing

marketplace, providing retailers and

[email protected] or visit www.ul.com/ consumer-products.

©2014 UL LLC All rights reserved. This white paper may not be copied without permission. It is provided for general information purposes only and is not intended to convey legal or other professional advice.

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Meeting the Demand for Quality Dietary Supplements

Works Cited 1

”Complementary and Integrative Medicine: Emerging Therapies for Diabetes, Part 1: Preface,” Diabetes Spectrum, Volume 14, Number 3, 2001, the American Diabetes Association. Web 7 August 2014. http://spectrum. diabetesjournals.org/content/14/3/129.full.pdf+html.

2

“Dietary Supplement Adverse Event Reports Increase,” Natural Products Insider, April 2, 2014. Web. 21 May 2014. http://www. naturalproductsinsider.com/news/2014/04/dietary-supplement-adverseevent-reports-increase.aspx.

13

Further details about the FDA’s food facility registration requirements can be found in “Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition),” December, 2012, U.S. Food and Drug Administration. Web. 21 May 2014. http://www.fda.gov/Food/ GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ ucm331959.htm.

14

More details about the FDA’s GMP requirements for manufacturers of dietary supplements is provided in “Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide,” December 2010, U.S. Food and Drug Administration. Web 21 May 2014. http://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/ucm238182.htm.

15

See the FDA’s “Guidance for Industry; A Dietary Supplement Labeling Guide” for additional information about labeling requirements for dietary supplements. April 2005, U.S. Food and Drug Administration. Web. 21 May 2014. http://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/DietarySupplements/ ucm2006823.htm.

16

Additional information about the FDA’s requirements regarding new dietary ingredients is available in its draft guidance document, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” July, 2011, U.S. Food and Drug Administration. Web. 21 May 2014. http://www.fda.gov/Food/ GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ ucm257563.htm.

17

“DNA barcoding detects contamination and substitution in North American herbal products,” Newmaster, Steven, et.al., BMC Medicine, October 11, 2013. Web. May 21, 2014. http://www.biomedcentral.com/17417015/11/222.

“United States Dietary Supplement Regulatory Update,” Slide presentation by Venable LLP, 2014. Web. 12 June 2014. http://www. venable.com/files/upload/US-Dietary-Supplement-Law-Update.pdf.

18

“Acute selenium toxicity associated with a dietary supplement,” MacFarquhar, J.K., et.al., Archives of Internal Medicine, February 8, 2010. Web. 21 May 2014. http://archinte.jamanetwork.com/article. aspx?articleid=415585.

“FDA takes enforcement action against Pennsylvania dietary supplement maker,” press release, U.S. Food and Drug Administration, November 23, 2011. Web. 12 June 2014. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm281017.htm.

19

“U.S. Marshals seize dietary supplements, drugs manufactured by Syntec, Inc.,” press release, U.S. Food and Drug Administration, December 1, 2011. Web. 12 June 2014. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm282030.htm.

20

“Seller of Unapproved Dietary Supplements Agrees to Pay $1,796,114.50 in Penalties & Restitution,” press release issued by the Office of the District Attorney, Alameda County (California), January 30, 2014. Web. 12 June 2014. http://www.alcoda.org/news/archives/2014/jan/unapproved_ dietary_supplements_seller_to_pay_17m.

3

“FDA Official: 70% of supplement companies violate agency rules,” Newsday, August 23, 2013. Web. 15 May 2014. http://www.newsday.com/ news/health/fda-official-70-of-supplement-companies-violate-agencyrules-1.5920525.

4

“Cashing in on the booming market for dietary supplements,” Consumer & Shopper Insights, a report by McKinsey & Company, December 2013. Web. 21 May 2014. http://csi.mckinsey.com/knowledge_by_region/ americas/dietary_supplements.

5

“Vitamins and Dietary Supplements in the U.S.,” Report by Euromonitor International, April 2013. Web. 21 May 2014. http://www.euromonitor. com/vitamins-and-dietary-supplements-in-the-us/report.

6

“FDA Uses New Authorities to Get OxyElite Pro Off the Market,” Blog posting by Daniel Fabricant, Director of Division of Dietary Supplement Programs, U.S. Food and Drug Administration. FDA Voice, November 18, 2013. Web. 21 May 2014. http://blogs.fda.gov/fdavoice/?s=dmaa.

7

“Dietary Supplement Use Among U.S. Adults Has Increased Since NHANES III (1988-1984),” NCHS Data Brief, U.S. Centers for Disease Control and Prevention, April 2011. Web. 21 May 2014. http://www.cdc.gov/nchs/data/ databriefs/db61.htm.

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10

“Lead, Mercury, and Arsenic in US- and India-Manufactured Ayurvedic Medicines Sold via the Internet,” Saper, Robert B., MD, MPH, et.al., The Journal of the American Medical Association, August 27, 2008. Web. 21 May 2014. http://jama.jamanetwork.com/article.aspx?articleid=182460 &resultClick=3.

11

“FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement,” FDA News Release, July 26, 2013. Web. 21 May 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm362799.htm.

12

“Sensa and Three Other Marketers of Fad Weight-Loss Products Settle FTC Charges in Crackdown on Deceptive Advertising,” press release from the U.S. Federal Trade Commission, January 7, 2014. Web. 21 May 2014. http:// www.ftc.gov/news-events/press-releases/2014/01/sensa-three-othermarketers-fad-weight-loss-products-settle-ftc.

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