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Ensuring supply chain integrity before beginning supplement operations

In this remarkable age of international supply chains, instant transmissions of electronic information and voice communications, and the varied impositions of tariffs by different governments, the need for supply “country of origin” transparency has never been greater.

Recent statements from FDA Commissioner Scott Gottlieb, M.D., showed the agency believes it needs to step up its enforcement of the abuses of the dietary supplement industry that have been exposed in recent years. Concerns associated with imported goods remain, including the undisclosed presence of active pharmaceutical ingredients or their analogs, which have been identified by agency laboratories. The agency realizes to safeguard the consumers, it needs to step up enforcement of quality checks for imported materials.

One mechanism of this guardianship is the policing of new dietary ingredient (NDI) submissions by issuing timely acknowledgements of notification acceptance and better managing import alerts to customs and border officials to prevent adulteration, misbranding and potential harm to the consumer. This mandates transparency in the supply chain and honesty in disclosure documents.

Supply chain integrity rests squarely with the finished brand, which is tasked with the selection, handling, testing and processing of ingredients and components, as well as the composition, dose and shelf life of the finished product, whether it be a powder, liquid, tablet or capsule or in confectionery form. This elevation of responsibility was defined in statute with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the subsequent imposition of the cGMP (current good manufacturing practice) requirements.

What remains a mystery is why almost half of the cGMP inspections conducted annually by FDA still result in either official or voluntary actions being taken by the firms inspected to correct deficiencies in some of the most basic components of a cGMP system, according to information obtained in a Freedom of Information Act (FOIA) request.

Supply chain transparency, or lack thereof, can contribute to significant problems with the agency and the products intended for commerce. Either producers of products in our industry are naïve, or they are willfully ignorant of their responsibilities. In certain circumstances, importers are willfully ignorant of what is in their products. Those that engage in such deception should be met with the full force of federal law, and the offending products should be subject to immediate seizure, no matter where or how the products are being sold in the United States.

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FDA dietary supplement initiatives will continue after Gottlieb’s departure

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.

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Finished product innovation give sports nutrition consumers more options

The global sports nutrition market is, in a word, massive. And it’s only going to continue to grow.

Different research firms will give you different dollar figures, but the consensus is the market is huge and only getting bigger. Grand View Research predicted the global sports nutrition market will reach US$24.43 billion by 2025, growing at a compound annual growth rate (CAGR) of 9.7 percent. Market Research Future is even more bullish, predicting the global market to reach $39 billion by 2020; Zion Market Research predictions go even further, estimating the market will reach $45.27 billion by 2022.

Not long ago, this market consisted mainly of two things: electrolyte-filled sports drinks and ready-to-mix protein powders. And while these products still make up the largest parts of the sports nutrition market—Euromonitor International expects those two subgroups to account for more than $7 billion each in 2020—they are hardly alone in today’s sports nutrition market. Supplements, bars, sweet and savory snacks, spreads, baking mixes and more now inundate the sports nutrition market as consumers seek new and innovative ways to obtain the benefits they seek.

With an ever-growing consumer base, the key for brands who wish to take advantage is to be sure they have a product for everyone.

Brands like Kodiak, IDF, Natural Force and others all understand this changing landscape. As the sports nutrition market continues to expand from athletes and body builders to the population at large, supplementation should continue to take new forms.

As Grand View researchers put it, “[A] growing consumer base…[and] widening base of health-conscious population are anticipated to foster the growth of the market over the coming years.”

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Personalized nutrition for the supplement industry

Personalized nutrition is the future. Currently, the model for pharmaceutical companies is treatment that will work for most patients, while modern wellness is moving toward a model that determines if a treatment works for an individual patient. Personalized nutrition equips consumers with the knowledge and power to make choices about desired actions as it relates to customized individual health and wellness; the making of “the citizen doctor.”

Major disruptors exist in every industry. Firms such as Uber, Spotify and AirBnB have turned age-old industries on their heads. We should expect the same in the health space. However, the health industry faces unique challenges. For one, the market is highly regulated, making it slow to change. Second, the lack of shared data hinders growth. Third, quality assurance (QA) is key. These roadblocks to progress are set to ensure the highest level of care and privacy for consumers.

This empowerment to the patient is now occurring because consumers can analyze their DNA at a reasonable cost, which was unheard of a few years ago. The tools of personalized nutrition can be evaluated in five major areas that can be innovated using data:

  • Gene sequencing
  • Brain mapping
  • Vitals tracking
  • Big data
  • Genetic customization

These tools rely on the advancement of technology and the complexity of computers to lead the charge. On the surface, taking this approach to developing new ingredients is costly and time consuming. However, it quickly becomes clear that personalized nutrition is not only better for consumers, but is also great for nutrition brands’ returns on investments (ROIs). Personalized nutrition allows patients to be treated to their own specifications, rather than in a generalized way, which may not be effective. Imagine being able to use exactly the right amount of a nutrient, and thereby reducing the amount of waste and ensuring efficacy.

An example is with curcuminoid as a personalized supplement. First, one’s personal situation is analyzed. Then, genome sequencing adds additional information. DNA-based variations in the genes or enzymes impact different consumers in a variety of ways. Knowing ahead of time if a patient will have an adverse reaction to treatment allows doctors and consumers to make a better-informed decision on the optimal dose or treatment. The curcuminoid is analyzed using rapid separation liquid chromatography (RSLC) technology, and other fingerprinting technology. This step is key. Rather than assuming each each plant is perfectly uniform, it assumes imperfections are in the system. This testing allows for quality control (QC) at the end product, not at the origin. The end game is efficient and cost-efficacy. Both the consumer and the supplier will see the upside of this.

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Antioxidant botanicals for joint support

According to the Centers for Disease Control and Prevention (CDC), more than 52 million Americans suffer from some form of arthritis—that’s 23 percent of the entire adult population. The joint nutraceuticals glucosamine, chondroitin and hyaluronic acid (HA) are agents that work well for joint support, but sometimes more intensive support is needed. Many herbs and botanical extracts have shown great promise in supporting joint health. Studies show a potent blend of these herbal extracts can provide tissue support benefits and relief from minor pain while supporting healthy joints and muscle tissue.

Botanicals can aid in the relief of muscular pain following intense exercise and provide antioxidants to help protect connective tissue from the damaging effect of free radicals. Devils claw extract, Boswellia serrata extract, turmeric root extract, bromelain, green tea, quercitin, grape seed extract, ginger and phellodendron have all been shown to exert a powerful influence for joint support.

Antioxidants are substances that fight free radicals—compounds in the body that can damage cells, DNA and cause cell death.

Green tea contains a high concentration of powerful antioxidants called polyphenols, which can neutralize free radicals and may reduce or even help prevent some of the damage they cause (Cell Biophys. 1989 Apr;14(2):175-85).

Quercetin belongs to a group of plant pigments called flavonoids, antioxidants that give many fruits, flowers and vegetables their color. In combination with other joint botanicals, it has been shown to impact muscle recovery and joint inflammation on tissues compromised by inflammation and its impact on muscle recovery (Nutr J. 2011 Sep 7;10:90. DOI: 10.1186/1475-2891-10-90).

Grape seed extract is one of the richest sources of antioxidants, including proanthocyanidins, that reduces the toxic effects of oxidative stress. Grape seed extract may be as much as 50 times more potent that vitamin E and 20 times more potent than vitamin C as an antioxidant (Int J Mol Sci. 2010;11(2):622-646).

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Don’t take it personally—Regulations are the same for everyone

“Personalizing” intake is among the most exciting and logical approaches to nutrition. Nothing is more personal than something a person puts inside their body, such as a food or dietary supplement. The challenge for food and supplement brands is to make them even more personal.

The industry is approaching personalization with vigor, but regulatory pitfalls face these enterprising brands. Personalization was not anticipated by those who made the regulations, but manufacturing and labeling must follow the same laws as the old, once-daily multivitamins.

Combinations of different supplements have been put together in packs for decades. These presentations take individual product formulas and combine them in packaging for specific needs. The evolution of this would be to tailor a series of supplements for the individual and package them specifically for that person. This goal is difficult to achieve logistically and is near impossible to do from the standpoint of the regulations.

Individual batch records are required for every lot of finished product. Each “personalized pack” requires its own individual batch record, along with the other regulatory documentation and testing. Individual containers of product must be released, since these constitute a single “batch.”

To make things even more complicated, brands could custom blend individual nutrition packets for consumers. Each of these individual blends requires a master manufacturing record (MMR) along with additional production documentation. The testing requirements would be increased significantly because the results of one customer’s product are not applicable to the next. The additional burden imposed on companies wishing to venture into this must be considered during the development of the business. Compliant mechanisms can mitigate these challenges, but many of these solutions undercut the purpose of personalization.

Multiple products providing different ingredients require “ad hoc” labels for each production, but all labels must still meet regulations. That’s fine when there are rolls and rolls of labels, but not so easy when they are printed on demand.

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Packaging takeaways

Consumers demand almost as much from the packages that hold their foods and supplements as they do from the products themselves. Packages must clearly communicate product attributes, must not harm the environment and must stand out among the sea of competitors on store shelves or in online searches.

Sustainable packaging can sway a consumer toward a product, or put them off, which has encouraged brands to use innovative packaging that uses less material and/or uses material that can be recycled or is made from recycled components. One such innovation in this area is packaging that can be composted in backyard gardens. However, “clean packaging” doesn’t have a universal definition, so brands must listen to their consumers and respond to their demands.

Brands must use these sustainable packages, but not at the expense of the safety or the quality of the products. Air-tight and micro-perforated packaging can separate contaminants from products, and thus maintain contaminate-free and unoxidized products. Packages should also be free of chemicals that could leak into the foods, causing spoiling or unpleasant olfactory effects. Product transport also needs to be considered as many shipping routes require goods to be stored in heat or cold for several weeks.

A sustainable, safe package won’t do consumers good if they aren’t attracted to the messages or design, so marketers must also use this real estate to best position their products. Along with product attributes, brand story and legal requirements, brands can highlight the packaging components to help build trust and transparency with customers. Millennials especially want a social media-ready aesthetic, so beauty and an “unboxing” appeal will bring more consumer interest.

Product claims cannot expand beyond the bounds of what is legal. Supplement and food packages cannot make disease claims, and health claims require FDA approval. Structure/function claims don’t require government pre-approval, but brands must notify FDA 30 days after marketing the dietary supplement with the claim.

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Demand for natural sweeteners continues to rise

More consumers are embracing health and wellness and seeking out better-for-you products, resulting in tremendous innovation in the food, beverage and supplement industries that deliver novel products to feed and fuel the mind, body and soul.

This new paradigm in consumerism also includes a desire for products formulated with ingredients consumers can pronounce, as well as products with shortened ingredient lists. Nowhere is this more apparent the food and beverage industry, where increased numbers of consumers are demanding transparency about how ingredients are sourced and how products are manufactured.

According to the 2018 Food & Health Survey from the International Food Information Council (IFIC) Foundation, most Americans think about the healthfulness of the foods and beverages they consume. When asked to choose between two versions of the same product—an older one with artificial ingredients and a newer version without—69 percent chose the product with no artificial ingredients, while 32 percent opted for the one containing artificial ingredients.

When asked to identify the healthier of two products with the same Nutrition Facts Panel, 40 percent perceived one labeled “non-GMO” (genetically modified organism) as healthier versus 15 percent for one with genetically engineered ingredients, and 33 percent believed a product with a shorter ingredient list was healthier than one with more ingredients (15 percent). What’s more, 62 percent of consumers said they would pay up to 10 percent more for a product without artificial ingredients, while 42 percent said they would pay 50 percent more.

IFIC data also revealed consumption of and opinions regarding sugars have shifted over the years, with 33 percent of Americans pointing to sugar as the most likely calorie source responsible for weight gain. The findings aren’t surprising given sugar content in foods and beverages has been a politicized issue because of its association with several chronic illnesses, chief of which include obesity, diabetes, cancer and heart disease.

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CBD in packaged food and beverages

Alcoholic drinks are by far the most embedded industry in the cannabis sector. At least three leading corporate players have a stake in cannabis producers, the most notable being U.S.-based Constellation Brands and its 38 percent share in leading Canadian cannabis producer Canopy Growth. With the spirits and beer categories already headed in a low- or non-alcoholic direction, a future where tetrahydrocannabinol (THC) replaces alcohol is on the horizon. Cannabis beverages, with specific THC dosing and controlled onset-of-effects, will become more common in places that have legalized recreational use, ultimately providing the equivalent effect of a glass of wine or beer. These would be calorie-free, non-alcoholic or alcoholic recreational beverages with an intoxicating buzz.

Health and wellness trends are driving the global soft drinks industry, fueled by sugar reduction. The functional health and wellness trend is thus a natural bedfellow for cannabidiol (CBD)-infused products. In soft drinks, CBD launches have become prevalent over the last two to three years, particularly in bottled water, juices, ready-to-drink (RTD) tea, RTD coffee and energy drinks, as well as THC inclusions where recreational use of cannabis is legal.

Tea is currently the most popular application for CBD products in hot drinks, particularly green tea and herbal tea, related as they are to health and wellness. As low- and non-alcoholic beverages grow in popularity, and sugary soft drinks continue to decline, a consumer trend confluence occurs between alcoholic drinks and soft drinks. These blurring lines are creating a fertile ground for adult recreational soft drinks, where cannabis (more specifically THC in the long term) fits in as a social lubricant with a health and wellness halo.

Within packaged food, Euromonitor International expects sales of CBD products to double over the next two years, as consumer awareness grows. CBD and THC are the superpower holistic food ingredients of the future—think turmeric (anti-inflammatory) crossed with coconut oil (essential fatty acids). CBD/THC falls within the naturally functional and mindful consumption trends, tapping into the vegan, plant-based and free-from movements. Given hemp is grown sustainably, it is also spurred by the ethical living megatrend and back-to-basics move. THC-combined CBD products are chiefly prevalent in sweet categories, such as confectionery (chocolate and sugar), protein bars and ice cream, with potential for savory snacks, pasta and soups, among others.

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FDA Commissioner Gottlieb resigns

FDA Commissioner Scott Gottlieb, M.D., has resigned and will leave his post next month after almost two years at the helm. The move was a surprise, given he tweeted just two months ago that rumors of his departure were not true and he was determined to lead the agency through challenging regulatory issues.

The public health agency has taken aim at the opioid crisis, teen vaping and, most recently, dietary supplement regulation.

“I want to be very clear – I’m not leaving,” he tweeted, on Jan. 3, 2019. “We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon.”

However, Gottlieb tweeted this afternoon, “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump – This has been a wonderful journey and parting is very hard.”

Gottlieb only said he was leaving, effective one month from today, to spend more time with family, whom reside in Connecticut, while Gottlieb works at FDA in the Washington D.C. area. According to the Washington Post, which broke the story, White House officials assured the move was not initiated by President Trump.

In a statement released online, Department of Health and Human Services Secretary Alex Azar praised Gottlieb as a “public health leader, aggressive advocate for American patients, and passionate promoter of innovation.” Azar said he would personally miss working with Gottlieb on policy. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

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