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How to Market Supplements Effectively

The nutritional supplement industry is growing fast in the United States. The demand for products that promote health and wellness is driven by a rapidly aging population, concern for chronic diseases, as well as an increasingly health-conscious younger generation. In turn, this creates stiff competition for business owners who choose to venture into this industry.

As a business owner, your main goal is to create a high-quality product that can stand out in a sea of rivals. Apart from making sure that you use high-quality ingredients and employ good manufacturing processes, it’s also important to market your supplement business effectively and help it stand out from the competition. Today, we’ll be talking about four simple ways to promote and distinguish your products from the crowd. Let’s get started!

Understand Your Target Market

Knowing your audience plays a key role in selling any product. Your marketing strategy should be a reflection of who your target demographic is so you need to understand who they are, what they like, and where they are. Typically, people who consume nutritional supplements are those with medical issues or are motivated by wellness, fitness, and preventive medicine. 

Consumer research can help you come up with the most efficient marketing strategy. By understanding your audience, you can design products that well-suited to their tastes and needs, create compelling promotional materials, and use advertising methods that will inspire people to buy your products.

Develop a Compelling Supplement Packaging Design

Packaging design plays a crucial role in the marketability of your product. As the face of your product line, it should look professionally-made, attractive, easy to read, and designed with your target market in mind. 

An eye-catching label and packaging design can help your supplements fly off the shelves. In this sense, it is important to leverage your product’s label and packaging real estate to draw your customers in. Evaluate packaging and design styles used by your competitors and determine how you can make yours stand out. You can also work with professional graphic designers to come up with a design that best suits your brand.

Have FDA-Compliant Labels

Apart from being attractive to your customers, your label should also comply with the standards set by the Food and Drug Administration. They have regulations on general labeling, identity statements, nutrition labeling, ingredient labeling, claims, net quantity of contents, as well as pre-market notification of new dietary ingredients. 

Your supplements should comply with these guidelines otherwise, you risk your product being legally barred from US distribution. This is a costly and time-consuming issue that can hurt your business. To avoid this, it is best to work with designers who have experience in creating labels that are FDA-compliant.

Bring Your Products to the Digital Sphere

In this digital age, your marketing strategy should involve the internet. Think social media, health and fitness websites, and other online channels where your target audience tends to gather. 

Digital marketing is a useful tool for spreading the word about your product and ensuring sales for your business. You can leverage fans and social media influencers as a form of word-of-mouth marketing. You can also use videos as well as affiliate marketing programs to reach a broader audience.

Trade groups to Congress: Authorize CBD in supplements

Four dietary supplement trade groups on Tuesday urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if the supplement meets established product safety and quality criteria.

Lawmakers also were asked to devote sufficient resources to shield consumers from unsafe CBD products.

While FDA has been examining the potential for a rulemaking that would authorize CBD to be added to food and marketed as a dietary supplement, agency officials have stressed such a process could take several years to complete.

Industry representatives have expressed fears that a lack of federal oversight could endanger the health of the public and continue to foster an environment of uncertainty, stymieing investments and innovation.

The U.S. market is already inundated with CBD products and a patchwork of state testing and labeling laws governing them.

Since at least 2015, FDA has asserted CBD can’t be marketed in a dietary supplement under federal law because, in short, the compound was first studied as a pharmaceutical drug. Last year, the agency approved the first CBD medicine, Epidiolex, to treat seizures associated with two severe forms of epilepsy.

Despite the drug-related exclusion above, the Federal Food, Drug & Cosmetic Act (FD&C Act) grants the head of the U.S. Department of Health and Human Services (HHS) discretion to authorize CBD to be marketed in supplements.

In the Oct. 8 letter to Congress, the trade associations noted any CBD products subject to such a “limited waiver” would need to meet the definition of hemp in the 2018 Farm Bill and comply with applicable requirements of the FD&C Act and FDA’s regulations related to dietary supplements, including requirements for new dietary ingredients.

Read The Full Article HERE

State hemp and CBD is still not easy to navigate

As FDA continues to contemplate potential regulatory pathways for hemp-derived CBD, an increasing number of states are moving forward with their own laws and policies aimed at regulating this popular product category, especially in the dietary supplement and food space.

Several states are imposing robust testing, labeling and registration requirements for these products—with more likely to follow—or restricting the sale of hemp and CBD-containing food and dietary supplements altogether, citing concerns about the absence of federal oversight.

Unfortunately for companies operating in this space, not all these state mandates are similar. Coupled with THC testing issues, many companies are faced with logistical challenges and supply chain headaches when it comes to navigating the various state regulations (and risks) for CBD and hemp products.

In addition to legalizing hemp and its derivatives, such as CBD, the legislation also directs USDA to create a regulatory framework for approving state-developed hemp plans as well as a federal plan for states that choose not to have primary oversight for the regulation of hemp.

Many states are currently in the process of developing hemp plans, which are primarily focused on the cultivation of hemp and related issues such as licensing hemp growers and THC testing. At the same time, they are also taking the opportunity to place restrictions or limits on the manufacture and distribution of finished products.

Read The Full Article HERE

Amarin asks Supreme Court to hear dispute involving omega-3 supplements

Amarin Pharma Inc. wants the nation’s highest court to hear a long-running dispute with several dietary supplement companies that the U.S. International Trade Commission (ITC) declined to investigate in 2017.

Amarin, the maker of the pharmaceutical drug Vascepa, filed a July 30 petition for a writ of certiorari with the U.S. Supreme Court after an appeals court affirmed ITC’s decision.

It’s Amarin’s last chance in the judiciary to compel ITC to investigate its complaint over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements, a category of products principally regulated by FDA.

A ruling by the Supreme Court could provide clarity over ITC’s authority to hear complaints involving unsettled issues within FDA’s expertise. A quasi-judicial federal agency, ITC has broad powers over matters of trade, including enforcement of the Tariff Act of 1930.

Representatives for FDA and ITC declined to comment on the petition.

“This case offers the Court an opportunity to restore the private rights of action that Congress granted parties under the Tariff Act of 1930 in order to protect domestic industry from unfair trade practices,” Amarin wrote in its 38-page petition through its outside counsel, Ashley C. Parrish of King & Spalding LLP.

Amarin’s grievances are with several prominent dietary supplement firms, including Nordic Naturals Inc., Nordic Pharma Inc., Pharmavite LLC, DSM Nutritional Products LLC and related DSM entities.

“We are disappointed that Amarin continues to pursue this issue, and we are confident that the U.S. Supreme Court will rule consistent with the ITC and the Federal Circuit Court rulings on this matter,” said Hugh Welsh, president of DSM North America, in an email.

Nordic Naturals, Nordic Pharma and Pharmavite did not immediately respond to requests for comment.

In its 2017 complaint, Amarin alleged the companies’ products above are unapproved new drugs under the Federal Food, Drug & Cosmetic Act (FDCA). Therefore, the false labeling of the products, Amarin argued, constituted an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards the FDCA established.

FDA asked ITC to refrain from an investigation because the agency hadn’t determined whether the products subject to the complaint were drugs or dietary supplements. And in June 2018, a U.S. Department of Justice (DOJ) attorney noted a guidance from FDA on the regulatory classification of these articles would not be forthcoming.

Read The Full Article HERE

FDA to issue ‘discretion policy,’ interim rule on CBD in dietary supplements

U.S. Sen. Ron Wyden on Tuesday urged top federal health officials to announce a “formal enforcement discretion policy” by Aug. 1 regarding CBD as a food additive or dietary ingredient in supplements.

Without such a policy, “hemp producers and their customers will continue to be left in a regulatory gray zone,” Wyden, a Democrat from Oregon, wrote to the leaders of FDA and the U.S. Department of Health and Human Services (HHS).

In a letter to HHS Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, M.D., Wyden also urged FDA to publish an interim final rule to ensure CBD can be lawfully sold in food and dietary supplements, pending the agency’s publication of a final rule.

Congress in 2018 removed hemp from the federal Controlled Substances Act (CSA), but lawmakers preserved FDA’s authority to regulate cannabis-derived products.

FDA has maintained CBD cannot be lawfully added to conventional food or marketed as a dietary supplement because essentially the compound was first studied as a drug. The agency, however, has authority to create an exception, and it hosted an all-day public hearing May 31 to examine issues around its regulation of cannabis-derived products.

Wyden characterized as “fully unacceptable” a suggestion by FDA that publishing a final rule authorizing the use of hemp-derived CBD in dietary supplements could take three to five years.

“The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” the senator wrote.

Wyden also urged FDA to streamline the process for reviewing safety-related notifications for hemp-derived CBD ingredients and dedicate staff to the process.

“I feel strongly the FDA must undertake a process to make lawful a safe level for conventional foods and dietary supplements containing hemp-derived CBD,” Wyden said.

Read The Full Article HERE

FDA commissioner highlights ‘unanswered questions’ regarding safety of CBD

FDA has many “unanswered questions” when it comes to the safety of cannabidiol (CBD), a cannabis-derived compound, the agency’s top official said last week.

FDA Acting Commissioner Norman “Ned” Sharpless, M.D., cited “real risks” and “critical questions” that remain regarding the safety of CBD and tetrahydrocannabinol (THC) in FDA-regulated products, including food and dietary supplements.

During a May 31 public hearing at FDA’s campus in Silver Spring, Maryland, more than 100 speakers representing myriad interests addressed CBD and THC issues, including FDA’s prospective regulation of cannabis-derived compounds.

The hearing was intended to obtain scientific data and information about the labeling, manufacturing, marketing, product quality, safety and sale of products containing cannabis or cannabis-derived compounds.

Sharpless underscored FDA has many questions about CBD that remain unanswered.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” he said.

Sharpless suggested population-based research focused on CBD was scant prior to the passage of the Agricultural Improvement Act of 2018, otherwise known as the Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA).

The “lack of evidence to support CBD’s broad use in FDA regulated products—including in food and dietary supplements—has resulted in unique complexities for its regulation,” he said, “including many unanswered questions related to … safety.”

For instance, Sharpless asked a fundamental question about CBD: How much of the compound is safe to consume in a day?

“What if someone applies a topical CBD lotion, consumes a CBD beverage or candy and also consumes some CBD oil?” Sharpless asked. “How much is too much?”

Sharpless also asked how CBD would interact with other drugs taken by a person, and he left unanswered the question of how the compound would impact the health of a pregnant women.

“What if children access CBD products like gummy edibles?” the commissioner asked. “What happens when someone chronically uses CBD for prolonged periods?”

FDA has concluded CBD and THC—the psychoactive compound responsible for the “high” from consuming marijuana—cannot be added to conventional food or marketed in a dietary supplement because the compounds were first studied as drugs. But FDA has authority to create an exception by issuing regulations, a process that could take several years.

Read The Full Article HERE

FDA urged to act swiftly to settle confusion in CBD market

“Time is of the essence.”

The statement, made by Andrew Kline of the National Cannabis Industry Association (NCIA), encapsulates the views of many people who attended a recent public hearing hosted by FDA on cannabidiol (CBD) products.

During the May 31 hearing in Silver Spring, Maryland, several speakers urged FDA to provide clarity to a confused marketplace and do so swiftly.

“We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market,” Kline said.

FDA is mulling whether to issue regulations that would permit CBD in conventional food and dietary supplements, but its search to answer questions over safety, effectiveness and other issues could lead to a years-long proceeding.

Based on its current interpretation of federal law, FDA has opined CBD cannot be added to conventional food or marketed as a dietary supplement because, in large part, it was first studied as a drug.

“Three to five years, at a minimum for rulemaking, is too long,” Megan Olsen, assistant general counsel of the Council for Responsible Nutrition (CRN), told FDA officials during the public hearing.

The debate over safety, she added, should not hamper FDA from promulgating regulations to allow for the use of CBD in supplements.

“There is already a regulatory framework in place that is proven to ensure the safety of dietary supplements and food—one that will automatically be implemented should FDA develop a regulation permitting CBD use in food and supplements,” Olsen said.

Read The Full Article HERE

FDA official highlights noncompliance with dietary ingredient requirement, enforcement challenges

Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting.

Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new dietary ingredient (NDI) into interstate commerce.

Although many companies are suspected of neglecting to comply with the notification requirement, the director of FDA’s Office of Dietary Supplement Programs (ODSP), Steven Tave, suggested his agency doesn’t have a way to accurately measure all the NDIs that should have been submitted to FDA but were not.

Part of FDA’s challenge is the law exempted from the NDI notification (NDIN) requirement dietary ingredients marketed before Oct. 15, 1994, and those that have “been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”

Nonetheless, Tave calculated less than 25 percent of the required NDINs have been submitted to FDA. His conclusion is based, in part, on an estimated 50,000 dietary products on the market today. Tave’s figure is at the low end of FDA’s estimates of the current dietary supplement products on the market, which could number as high as 80,000.

Only 4,000 products were on the market in 1994, according to Congress’ estimates, so at least 46,000 new dietary supplement products have been introduced since 1994.

Responding to criticism that companies have failed to comply with the NDIN requirement, industry sources have pointed out many new products are exempt from the NDIN requirement because they are, for example, combinations of old ingredients grandfathered under DSHEA.

Tave acknowledged such exemptions were not subject to the NDIN requirement.

“Let’s say 90 percent of these products did not require a notification,” he said. “That still leaves 10 percent of the products that did require a notification.”

That means the distributors or manufacturers of 4,600 products were obligated to notify FDA, providing evidence that their NDI is reasonably expected to be safe. However, only about 1,100 NDINs have been submitted to FDA since the law was signed, Tave reported.

Tave noted people could “quibble with the math,” but he suggested the order of magnitude was correct.

Read The Full Article HERE

FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements

Various Dietary Supplements 2019

FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements.

Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.

The tool is part of the agency’s efforts announced earlier this year to modernize its regulatory framework over supplements to meet the demands of an industry that has grown significantly over the last 25 years.

“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a statement announcing the tool. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This list is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.”

Yiannas also pointed to “bad actors” who “seemingly ignore the legal requirements for dietary supplements” as an issue threatening the safety of consumers.

“While many dietary supplements meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk,” he said. “As the agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being.”

FDA cited potential reasons for adding an ingredient to the list, including lack of pre-market notification based on regulatory requirements; exclusion from use in a dietary supplement; and/or not fitting FDA’s definition of a dietary ingredient.

Read The Full Article HERE

FDA dietary supplement initiatives will continue after Gottlieb’s departure

Scott Gottlieb

Despite the recent departure of Scott Gottlieb from FDA, the dietary supplement initiatives he set in motion are expected to continue under his successor. But it remains to be seen whether any substantive changes to supplement regulations or policies will be adopted under the current interim FDA commissioner.

Gottlieb, a physician who served as commissioner of FDA for two years and left the agency in early April, was widely regarded as a competent leader who spearheaded myriad initiatives and worked collaboratively.

National media reported the 46-year-old Gottlieb wanted to spend more time with his family after commuting weekly to Washington from his home in Connecticut. Gottlieb is currently listed as a resident fellow at the American Enterprise Institute (AEI), a conservative think tank, where he focuses on pharmaceutical policy, the cost of prescription drugs, FDA and other issues.

Under Gottlieb’s tenure in recent months, the agency announced plans to strengthen its regulation of dietary supplements and examine a potential legal pathway for the use of cannabidiol (CBD) in conventional food and dietary supplements. He also recently revealed the agency’s enforcement strategy related to CBD, which is widely sold in dietary supplements, cosmetics and other products.

“For supplements, Dr. Gottlieb’s tenure represents an era of FDA-industry collaboration that has never been observed before,” said Andrew Shao, interim senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), in an email. “Under Dr. Gottlieb’s leadership, the agency recognized for the first time the importance of dietary supplements for public health and the great impact the industry has had.”

Outside the dietary supplement industry, the physician and former venture capitalist built a reputation for leading many initiatives focused on tackling high drug prices, strengthening food safety, preventing the use of e-cigarettes by minors and other public health issues.

“Commissioner Gottlieb’s resignation is a loss for the consumer products industry because he has shown a willingness to give industry guidance in areas that you often don’t see from agencies,” Raqiyyah Pippins, a lawyer in Washington with Arnold & Porter Kaye Scholer LLP, who focuses on FDA regulatory issues, said in an email.

Read The Full Article HERE

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