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

Dont take it personallyRegulations 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

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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The plant-based protein market — deep dive

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In the past decade, products made with plant proteins have evolved to include a wide variety of flavors, textures and formats for every eating occasion. A broader range of consumers now seeks plant-based protein goods, particularly consumers under age 40 who eat meat but are incorporating other options. Dairy alternative, sports nutrition and snacks are some of the top categories for plant-protein products, drawing from sources such as soy, pea, lentil and ancient grains.

Takeaways for your business

• Taste is the top reason for eating plant proteins, far outranking concerns about environment or diet.
• 46% of consumers surveyed believe plant-based proteins are healthier than animal-based counterparts.
• Convenience foods, prepared breakfast items, frozen prepared foods and entrées show great potential.

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CBD: A legal and regulatory update

CBD A legal and regulatory update

Over the past few years, cannabidiol (CBD) has become a household term. Moms, dads, brothers, sisters and even grandparents know what CBD is. At the least, they have probably heard of it. Cannabis sativa L. is a plant that includes both marijuana and hemp. CBD is a naturally occurring cannabinoid found in the cannabis plant. Hemp has a much lower concentration of delta-9 tetrahydrocannabinol (THC), the psychoactive chemical found in high amounts in marijuana.

On Dec. 20, 2018, President Donald Trump signed the Agriculture Improvement Act of 2018 (2018 Farm Bill), changing the landscape for companies involved in the hemp industry. Prior to the 2018 Farm Bill, the 2014 Farm Bill governed the growing and cultivation of hemp in the United States. The 2014 Farm Bill allowed for the growing and cultivation of “industrial hemp,” which was defined as “the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” The 2018 Farm Bill significantly broadens the definition of “hemp” to mean “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Notably, the 2018 Farm Bill simply states “hemp” in its definition, rather than “industrial hemp,” and it includes the specific parts of the plant and its chemical constituents.

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Getting Ahead of the Curve: Consumers Seeking Specialty Nutritionals

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As the variety of supplements, functional foods, ingredients, and bioactives continue to diversify to meet an ever more sophisticated list of health/wellness issues, it’s not surprising that
consumers are beginning to worry if they’re getting enough of the specialty nutritional ingredients they perceive important for their needs.

While 20% of adults don’t think they get enough basic vitamins/minerals, even more consumers—30% of gen Xers, 27% of millennials, and 24% of adults overall—don’t believe they get enough specialty nutrients, according to FMI’s 2018 U.S. Grocery Shopper Trends. Women (26% vs. 20% of men) are more likely to be concerned about their intake of specialty nutrients; one in five boomers and 16% of matures.

After vitamins/minerals, specialty supplements are the most used category of dietary supplements, taken by 51%; followed by herbals/botanicals (41%), sports nutrition (32%), and weight management supplements (20%), according to the Council for Responsible Nutrition’s2018 Consumer Survey on Dietary Supplements.

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Marine Ingredients: Sourcing from the Sea

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Virtually all scientists believe that life on Earth originated in the sea billions of years ago. If one accepts this premise, it comes as no surprise that the sea and other waters of the world continue to produce natural ingredients that enhance health and contribute to an active, vibrant lifestyle.

The first, of course, is fresh water itself, which humans need for drinking and to provide—via evaporation, rain, and irrigation—the moisture needed to nourish vegetation, forestation, and cultivated crops. Within the foreseeable future, it’s possible people will use the salted sea for the majority of drinking water, too, thanks to desalinization efforts around the globe.

Other health-giving substances from the sea include many thousands of varieties of plant and animal matter that grace dinner tables, providing essential macro- and micronutrients. And then there are specialized oils, extracts and more that have become critical components of the marine ingredients segment of the broader nutraceutical industry.

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Krill oil for heart health

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The market for heart health supplements is thriving. According to Nutrition Business Journal (NBJ) data, the market for heart health ingredients has the potential to reach more than US$3 billion by 2020. With that in mind, there are many options for consumers seeking out heart health products.

Omega-3s are considered a strong contender in this market. In fact, research has shown long-chain omega-3s support healthy blood pressure and cholesterol levels, normal blood clotting processes, as well as a regular heartbeat, all of which contribute to keeping both the heart and its arteries healthy.1,2 The anti-inflammatory nutrients found in omega-3s can help balance the body’s level of inflammation, promoting overall health and wellness.3

Every person’s omega-3 needs are different and the amount of EPA and DHA one would need to take to raise their Omega-3 Index into the target range will vary. Not all omega-3s are created equal. They vary in structure and function, and only marine-based omega-3s (or long-chain omega-3s) contain EPA and DHA.

Krill oil provides EPA and DHA mainly in the form of phospholipids. The body immediately recognizes phospholipid omega-3s and incorporates them into the cells before carrying them to the tissues and organs that need them the most, such as the heart. On the contrary, other sources of omega-3s are delivered as triglycerides and must be processed in the liver before they can be taken up by the cells and used by the body. Therefore phospholipid-bound omega-3s, like krill oil, raise one’s omega-3 index more efficiently as compared to other omega-3 oils.4

In addition to omega-3 fatty acids EPA and DHA, krill contains the essential nutrient choline, which is crucial for cell structure, function, and signalling.5 Choline is found to positively contribute to cardiovascular, liver and cognitive health. Furthermore, the astaxanthin found in krill oil helps keep its omega-3s naturally fresh and stable.

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New research on curcumin’s health benefits

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The big question about turmeric and curcumin asks how long its explosive growth will last. Will this superstar spice ingredient sustain its popularity and reach omega-3 status or fade into the background as a once-hot natural product trend? Thanks to the wide body of data generated in recent years, curcumin’s benefits categories have broadened substantially.

Sports nutrition is an up-and-coming benefit sector for curcumin, especially in light of its potential to reduce inflammation and soreness caused by strenuous exercise. The antioxidant benefits of curcumin and its ability to modulate inflammatory pathways underscores its potential as an adjunct to recovery.1

In a recent randomized, double-blind, placebo-controlled study, curcumin was shown to be an effective supplement for recovery after strenuous exercise.2 An additional study also reported a reduction in 24-hour pain scores as well as increased muscle performance after a muscle-damaging exercise.3

Curcumin is also finding potential in heart health, where the effects of its anti-inflammatory properties are being researched. Recently, a highly bioavailable form of curcumin was studied in a healthy population to examine its role in endothelial function, which plays a critical role in cardiovascular health.4 Curcumin’s direct impact on healthy circulation was measured using flow mediated dilation (FMD).

The randomized, double-blind, placebo-controlled study showed supplementing with 200 mg of curcumin had a clinically meaningful impact on potentially reducing cardiovascular disease by up to 50 percent in healthy individuals.

As the buzz around turmeric and its active component, curcumin, continues to spread, market opportunities for these popular ingredients are expanding.

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IP trends in sports nutrition

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Patent filings directed to sports nutrition continue to generally grow year over year. The trend is particularly pronounced on a global scale.

The increase in patent filings (through 2016) of sports nutrition products has been occurring outside the United States, with a large portion of filings in China. Brazil and Russia, which are not usually on the top filer lists, have weighed in with a significant amount of patent filings specifically associated with sports nutrition.

Sports nutrition ingredients may be formulated into food products, such as modified foods or complete food formulations. Alternatively, specialized ingredients may be incorporated into single or multi-ingredient nutritional supplements. To be patentable, these types of formulations must include a unique non-naturally occurring single ingredient or a previously unknown combination of ingredients, among other innovative features.

Trademarks for sports performance products include some expected terms like “sport,” “perform,” “strong” and “fast.” Since these terms are common, they cannot be registered in trademarks on their own. Common terms and variations thereof must be coupled with more distinctive terms to obtain trademark registration.

Careful consideration is required to determine if a particular combination is available. Trademark availability searches from trademark counsel can help find a potential trademark that does not encroach upon the rights of a third party’s trademark.

Finally, a steady increase in the term “performance” may indicate the sports nutrition performance field is still growing. Opportunities still exist for innovative products and brands to carve out their exclusive rights in an exciting area of nutritional products.

This is an excerpt from the article, “Intellectual property trends in sports nutrition.” To read the complete article, download the Sports nutrition: Performance digital magazine.

Read The Full Article HERE

FDA still finding same cGMP deficiencies at dietary supplement facilities

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FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.

In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged cGMP violations—were cited for failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, FDA data revealed. This was the most common cGMP observation in FY18 year as well as in FY17 when 24 percent of firms (89 inspections) were cited for the same infraction, according to FDA data INSIDER obtained through the Freedom of Information Act (FOIA).

Over the years, FDA has repeatedly emphasized the importance of setting and following specifications for the identity and other key attributes of a dietary supplement. Without doing so, FDA and outside cGMP consultants have said, manufacturers have no reliable way to know and verify what is in their products.

Nearly half (274 inspections, or 46 percent) of the 591 inspections in FY18 didn’t receive a Form 483, which suggests those dietary supplement manufacturing facilities are fully compliant with the cGMPs.

Warning Letters

There may be another silver lining. Data analyzed by the Natural Products Association(NPA) suggested an increasing number of firms cited in Form 483s for failing to establish product specs make the necessary corrections without requiring an admonishment from FDA in a subsequent warning letter.

NPA, a trade association founded in 1936 and led by former FDA officials, reviewed FDA warning letters to analyze alleged infractions of the cGMPs.

In reviewing the data dating back to 2010, NPA identified a change in the most cited cGMP violation. Through the first nine months of 2018, FDA most commonly cited dietary supplement firms in warning letters for failing to establish and follow written procedures for the responsibilities of quality control operations. In FY18 Form 483s, the latter cGMP infraction was the second most cited cGMP observation (52 inspections, representing around 16 percent of all Form 483s).

In the previous three years, the most common cGMP violation reported in FDA warning letters was related to specifications to establish when devising a production and process control system, NPA reported this week in a chart within a news release. The above infraction dropped to the third most-cited cGMP violation in 2018 warning letters, while the second most commonly cited infraction related to recordkeeping requirements for production and process control systems.

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