Call Us Toll Free (800) 688-5956
WE ARE OPEN AND TAKING ORDERS. IMMUNE FORMULAS AVAILABLE.

L-Lysine: More Than A Herpes-Fighting Agent

A picture containing tree, outdoor

Description automatically generated

For many years, people have associated lysine with its ability to treat the herpes virus. While it is true that this amino acid is a potent virus-fighting agent, it also delivers a handful of other benefits.

Today, we’ll be taking a look at how l-lysine plays a crucial role in various functions in your body and why you might want to consider supplementing it in your diet.

L-Lysine at a Glance

A close up of a logo

Description automatically generated

L-Lysine is the form of the essential amino acid Lysine that the body easily absorbs and uses for protein synthesis. It was first discovered in 1889 by Dreschel when he isolated the amino acid from casein.

It is commonly used to treat the herpes virus and to ease discomfort caused by cold sores. The body also uses lysine to build proteins that are critical for growth and development, disease prevention, and maintenance of bones and connective tissues. 

Since it is an essential amino acid, your body cannot produce it on its own. You need to consume foods that are rich in lysine including lean bead and lamb, parmesan cheese, turkey and chicken, pork, roasted soybeans, tuna, shrimp, pumpkin seeds, eggs, and white beans.

Role of L-Lysine in the Body

A piece of bread on a cutting board

Description automatically generated

As a natural disease-fighting agent and a building block of protein, it plays a crucial role in many bodily functions. Apart from fighting the herpes simplex virus and protein synthesis, this amino acid is also a critical part of several biological functions. 

It aids in crosslinking collagen polypeptides as well as in the uptake of mineral nutrients. When combined with vitamin C, l-lysine also produces carnitine, a compound responsible for fatty acid metabolism and cholesterol reduction. The body also uses lysine to produce certain enzymes, hormones, and antibodies.

L-Lysine Benefits

  • Lysine has shown to improve calcium absorption and retention in the body. This can result in healthier bones, reduced calcium loss, and reduced risk for calcium build up in the blood vessels.
  • It is traditionally used to treat cold sores or fluid-filled blisters that often appear on the corners of the mouth, caused by the herpes simplex virus type 1 virus.
  • It can reduce anxiety when used in conjunction with arginine. Research has shown that supplementing with lysine can help reduce cortisol levels and anxiety scores in healthy humans.
  • Since Lysine is crucial in the formation of collagen, supplementing with this amino acid can help promote wound healing and speed up the healing process. 
  • A form of L-lysine called poly-L-lysine was found to have anti-inflammatory effects in the lining of the stomach. While it needs further research, current studies claim that it can help prevent the leaky gut syndrome.

Dosage Recommendations

The average person needs a daily dose of 800 mg to 3,000 mg of L-Lysine per day. While you can easily source this amino acid from the food you eat, you can still take a dietary supplement if you aren’t able to meet your daily value recommendations. 

Meanwhile, for the purpose of herpes and cold sores treatment, the commonly recommended dosage is between 1000 mg to 3000 mg of l-lysine.

Safety Considerations

Taking lysine through your diet is considered safe and free from side effects. However, excessive intake of this amino acid through supplements may have some minor side effects including stomach pain and diarrhea.

People with kidney and liver issues should also consult with a healthcare professional before taking lysine supplements. Meanwhile, pregnant women should avoid taking l-lysine supplements.

L-Valine: Take Your Workouts to the Next Level

A picture containing woman, sky, person, outdoor

Description automatically generated

Many athletes know that a good branched-chain amino acid (BCAA) supplement is important for an efficient workout. Apart from increasing your muscle mass and improving endurance, these supplements also help prevent muscle breakdown as well as post-workout soreness.

Today, we’ll be talking about one specific BCAA that does that more. If you’re looking for a supplement that will help you from the moment you step into the gym until after your workout then L-Valine might just be for you!

L-Valine at a Glance

A close up of a logo

Description automatically generated

L-Valine is the dietary supplement form of the BCAA valine. It is commonly taken by weightlifters and performance athletes to support muscle and tissue repair as well as to provide them with adequate energy while performing taxing activities. 

As an essential amino acid, the human body cannot produce valine. It should be sourced from food such as dairy products, eggs, red meat, fish, fermented soy products, poultry, nuts, seeds, beans, mushrooms, and gluten-free whole grains. Athletes also often take l-valine supplements to increase their daily intake of this BCAA.

How It Works

A person posing for a picture

Description automatically generated

L-valine functions in the same way as the other BCAAs leucine and isoleucine. It encourages protein synthesis in the muscles which result in muscle building. This also translates to the reduction of muscle wasting or breakdown. Valine does this by supplying the muscles with extra glucose to be used for energy production during intense exercise.

Apart from supporting protein growth, it also discourages problematic brain cell messaging. People with liver disease and anorexia can benefit from this.

L-valine also helps support muscle coordination and strength while supporting cognitive growth. 

L-Valine Benefits

A picture containing cup, food, indoor, table

Description automatically generated
  • A study in 2018 revealed that L-valine supplementation aids in improving the recovery rate and perceived muscle soreness among people who engage in a strenuous workout and other sports activities.
  • L-Valine also helps in preventing muscle breakdown and boosting athletic performance. 
  • A research study published in 2018 also revealed that L-valine aids in the reduction of fatigue during exercise.

Dosage Recommendations

A young girl jumping in the air

Description automatically generated

When taking L-Valine is a dietary supplement, the most common dosage is 1000 mg to 2000 mg taken once or twice per day depending on your needs. It is, however, important to consult a physician first before taking this dietary supplement

While it can be taken alone, it is recommended to take it with the BCAAs leucine and isoleucine at a ratio of 2:1:1 pf leucine, isoleucine, and valine respectively. 

Safety Considerations

It is important to stick to the recommended dosages of L-Valine. When taken in excessive amounts, it may cause hallucinations, high concentrations of toxic ammonia in the body, and decreased liver and kidney function.

Beta-Alanine: A Fatigue-Fighting Amino Acid

A picture containing person, woman, indoor

Description automatically generated

Whether you’re a runner wanting to go a little farther or a bodybuilder who needs to perform more repetitions while training, having muscle endurance is important.

Muscular endurance plays a crucial role in improving your ability to support daily activities as well as your performance in sports and exercise. It allows your body to sustain a load for longer periods and more efficiently.

If you’re looking for a way to improve your ability to perform repetitive movements over long periods then you might want to consider taking beta-alanine. Here’s a rundown on this fatigue-reducing amino acid.

Beta-Alanine at a Glance

Chemical structure of beta-alanine.

Beta-alanine is a non-essential amino acid derived from modifying alanine and a substrate of carnosine. Research suggests that supplementing with beta-alanine can help prevent fatigue during high-intensity exercise.

Unlike other amino acids, your body uses beta-alanine in combination with histidine to produce the chemical carnosine, the key to reducing exhaustion during high-intensity activities.

Although most people can get sufficient amounts of beta-alanine from food sources such as meat, poultry, and fish, supplements can help raise its levels in your body even further.

How It Works

Beta-alanine supplements increase carnosine by up to 80 percent in your body which reduces the acidity in your muscles during high-intensity exercise.

During exercise, your body breaks down glucose as a main source of fuel into lactic acid. This is then converted into lactate which makes the muscles more acidic. The acidity reduces your muscle’s ability to contract which causes fatigue. Carnosine acts as a buffer against the acid in your muscles which lessens overall exhaustion.

Beta-Alanine Benefits

A picture containing person, indoor, sport, table

Description automatically generated
  • It increases your time to exhaustion. As a result, it helps you exercise or perform athletic activities for longer periods.
  • It improves your performance and improves your capacity during high-intensity and short-duration exercise.
  • It can boost training volume while reducing fatigue during resistance training.
  • Since it can help increase exercise volume, beta-alanine can also help promote muscle growth and improve your body composition.
  • Animal studies have shown that carnosine has anti-oxidant, anti-aging, and immune-enhancing properties. It can neutralize free radicals and reduce oxidative stress. However, human studies are yet to be conducted to support this claim.
  • There are also test-tube studies suggesting that carnosine elevates nitric oxide production which can help improve heart health.
  • Increased carnosine can also improve the function and quality of muscles in older adults.

Dosage Recommendations

A picture containing table, indoor, coffee, cup

Description automatically generated

The standard daily dose for beta-alanine is between 2 and 5 grams. Note that most pre-workout supplements already contain beta-alanine so it’s best to read the label before taking supplements.

According to a study conducted at Ghent University, consuming beta-alanine with a meal can further increase carnosine levels in the body.

Safety Considerations

Excessive amounts of beta-alanine may cause paresthesia or tingling of the skin experienced in the face, neck, and the back of the hands. Note that the tingling sensation increases with dosage size. According to the International Society of Sports Nutrition, this can be avoided by taking smaller doses (around 800 mg) at a time.

It can also cause a decline in taurine levels as beta-alanine competes for absorption in the muscles. 

L-Leucine: A Muscle-Building Amino Acid

leucine

Resistance training often first comes to mind when it comes to building muscle. However, if you want to build muscle mass and strength successfully, working out is not enough. You need to fortify your efforts with a rich protein source to support its synthesis in the body.

While a balanced diet can ideally support your protein needs, sometimes you need a little extra boost from nutritional supplements. If you’re looking for a way to promote muscle formation in your body, then L-Leucine might just be what you need.

L-Leucine at a Glance

leucine

L-Leucine is the dietary supplement form of leucine, a branched-chain amino acid (BCAA) found in protein. It is well-known for its roll in stimulating muscle growth. Compared to other BCAAs like isoleucine and valine, it can activate the growth pathways needed to stimulate skeletal muscle synthesis by up to ten times.

Since it is an essential amino acid, your body cannot produce leucine which means you need to supplement it in your diet by eating protein sources such as egg whites, chicken, beef, pork, tuna, soy-based products, beans, eggs, and dairy products.

Including leucine in your diet, even if you’re not a bodybuilder will help your muscles grow and thrive resulting in many health benefits such as:

  • Increased Metabolic Rate. Muscles are known to burn rather than store energy. This means the more lean muscles, you the bigger your energy requirements are. This eventually results in you your body’s burning more fat.
  • Ease of Performing Daily Activities. The more lean muscles you have, the stronger you are likely to be. This means you can perform daily tasks more efficiently.
  • Better Body Composition. Lean muscles make for an awesome-looking physique. Not only will your body look toned but your clothes will also fit better.

How It Works

Leucine stimulates muscle growth by activating the muscle-building pathway called the mechanistic target of rapamycin or mTOR. The increase in leucine levels in the body signals mTOR to build muscle because there are sufficient nutrients and amino acids to support it. 

It should be noted however that you need to reach the leucine threshold if you want your muscles to grow. In other words, you need to have enough leucine to support the growth of your muscles.

L-Leucine Benefits

leucine
  • Muscle gain. L-leucine is a popular supplement among bodybuilders thanks to its muscle gaining effects. Research suggests that when combined with a good variety of protein-rich food in your diet, supplementing with L-leucine can promote muscle growth and enhance athletic performance.
  • Reduced muscle loss. As you age, your skeletal muscles deteriorate which can cause weakness ad decrease stamina. L-leucine helps improve muscle synthesis in older adults which slows down age-induced muscle loss.
  • Improved athletic performance. Apart from promoting muscle growth, l-leucine also improves endurance and power in athletes and helps improve functional performance in older adults. 
  • Improved muscle recovery. People are prone to muscle soreness following intense physical activity. With the help pf l-leucine, your body can recover more efficiently.
  • Stabilized blood sugar. Studies are suggesting that l-leucine can play a role in stabilizing sugar levels in the body when taken together with glucose.

Dosage Recommendations

L-leucine is available in doses ranging from 2,000 mg to 5,000 mg. It is usually taken alone or alongside low-protein meals.

When taking l-leucine, it is best to start taking low doses first to assess your tolerance and then work your way up.

Safety Considerations

While consuming leucine supplements is safe and free from side effects, taking it as a supplement entails precaution.

Leucine toxicity can cause delirium and neurologic compromise. High intake of l-leucine can also aggravate the symptoms of pellagra in people with niacin deficiency. Moreover, its high doses of leucine can also increase the levels of ammonia in the blood. 

Omega-3 sources for supplement differentiation

At one time, cold water fish was the predominant source for omega-3 fatty acids, but “fish burp” pushbacks, and calls for more sustainable and vegetarian alternatives have given rise to a marketplace flourishing with choice—which can be simultaneously as wonderful as it is confusing to consumers. For omega-3 brands, playing up a product’s unique ingredient origin can help unlock elusive on-shelf differentiation, regardless of whether the product hails from fish, krill, algae, ahiflower, calamari or flax.

To be clear, consumers have a healthy interest in fish-origin docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).Chris Gearheart, director, member communications and engagement, the Global Organization for EPA and DHA Omega-3 (GOED), said the market for those ingredients has grown at least 2% in volume and value for each of the last three years, according to the 2016-17 edition of GOED’s EPA and DHA Omega-3 Ingredient Market Report. However, the overall market is being shaped by two forces: mass market activity and interest from new users.

Eric Meppem, co-founder, Pharmako Biotechnologies Pty Ltd., said the mass market has been commoditized. “Pundits state the market is flat or shrinking, but due to lower retail prices and larger pack size, actual omega-3 use is rising,” he said, adding that the factors are causing margin pressure throughout the supply chain.

New, emergent users typically embrace new omega-3 sources or delivery systems. “In most markets, these are more specialized, but mass-market brands are now considering these, wanting to broaden their offerings and combat margin squeeze,” he explained.

Top drivers behind interest in newer omega-3 sources include bioavailability and absorption, as well as ecological concerns like sustainability from sea-origin ingredients.

Organic Technologies, producer of AlaskOmega omega-rich fish oil products, begins with wild-caught Alaska pollock oil from Alaska’s Bering Sea. Steve Dillingham, vice president of sales and marketing, said the expansive U.S. Alaska pollock fishery is responsibly managed, with less than 1% bycatch and certified 100% sustainable and traceable by the Marine Stewardship Council. AlaskOmega oils are also certified sustainable through the Marine Stewardship Council chain-of-custody program, considered the gold standard by the industry.

Kate Pastor, senior vice president, Superba North America, Aker BioMarine Antarctic US LLC, said she believes ongoing investments in science and innovation are contributing to the vibrancy of the krill oil market. Aker BioMarine recently announced that it would be exploring krill oil’s potential benefit in new areas of study, including sports nutrition, skin health and Lupus.

“More novel sources of EPA and DHA omega-3s like greenshell mussel, hoki and calanus have seen double-digit growth in volume and value recently, but they are starting from a much smaller base,” explained GOED’s Gearheart, based on the 2016-17 edition of GOED’s EPA and DHA Omega-3 Ingredient Market Report. “Some of these unique ingredients appeal to Chinese consumers, for example, because they are especially interested in products from certain geographic regions—mussel oils come largely from New Zealand, [and] calanus saw most of its growth in the U.S. and Europe, where consumers may be drawn to the chance to revisit omega-3 consumption in a novel way.

Read The Full Article HERE

FDA’s limited view of inflammatory claims

Sports and other physical activities involve strenuous use of muscles, tendons, ligaments and such, leading to inflammation of the tissues and joints. Our own physiology gives us the ability to address this inflammation. We possess a system that deals with inflammation, known as the cholinergic anti-inflammatory metabolic pathway. It carries signals to and from cells in response to inflammation.

Keeping this system in good health is a good idea, but it can be challenging for natural product brands to communicate how products or ingredients can aid in this effort due to the regulatory realities of structure/function claims.

In the initial years after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the requirement to notify FDA of intended structure/function claims meant brands sent claims to Center for Drug Evaluation and Research (CDER) for evaluation. This drug branch of FDA was not an appropriate place for review of this newly formed class of claims, but that was the reality. Claims involving inflammation were submitted, and the general concept of addressing inflammation with supplementation was allowed (by virtue of no written objections to such claims). In the rulemaking discussion, inflammation claims in joints was noted as off limits, but not anti-inflammatory actions of the body generally.

However, about five years ago, FDA alerted the industry that it determined inflammation claims in nearly all instances constitute a drug claim. The agency reasoned the anti-inflammatory system of the human being is not always active. This contrasts the immune system, which is always active. Thus, claims involving support of a “system” that is always turned on are allowed but supporting a “system” that turns on in response to dysfunction and/or damage involves a pharmaceutical action. FDA made an exception where inflammation and discomfort are occasional and the result of strenuous exercise. Exercise apparently does not cause damage or render any part of the body dysfunctional regardless of how strenuous the exercise, though I have some personal stories to the contrary.

Ingredients used in dietary supplements are substantiated to benefit or reduce inflammatory processes. That is a truth. The basic standard for claims is that they be “truthful and not misleading” per the Federal Food, Drug, and Cosmetic Act (FD&C). Substantiation is the legal and regulatory requirement to meet this standard. When this is in place for inflammation claims, however, other standards come into view. This narrower finding by FDA is simply that: a finding. It is not a regulation. It is not guidance on the topic nor is it published as official. However, FDA has emphasized statements such as “supports healthy inflammation response” are unauthorized. This is owed to inflammation being considered a dysfunctional state. When it is the result of something not vector-driven (disease) or injury-caused (damage), the inflammatory response is a result of something other than normal, which is the standard for which dietary supplements are intended to benefit. Where these boundaries are drawn is blurred and not adjudicated. Regardless, without continual challenge to these soft boundaries, the interpretation of the law by the agency about claims remains an ever-shifting and narrowing landscape as shown by the anti-inflammation issue.

Read The Full Article HERE

Optimizing the precision blending of supplements

Nutraceutical ingredients can be formulated into a wide variety of health-related products, including vitamins, supplements, mineral blends and foods like energy bars. Many of these formulations involve the fine blending of as many as 40 to 50 components, including powders and trace elements.

While nutraceuticals are not regulated like pharmaceuticals, the products still must substantiate label claims, and a number are tested in clinical studies like medicines.

Whenever a nutraceutical makes a label claim, like a specific recommended dietary allowance (RDA) or FDA allowances, vitamin percentages or active components, it must meet those criteria. Further, nutraceutical products must not only avoid doing harm, but also increasingly substantiate any claims or benefits.

One industry challenge is that the blending of solid ingredients is easier and more uniform if the ingredients are approximately the same size. However, it is difficult to create precise blends with trace ingredients (less than 1%) that are dissimilar in size and density. In some cases, this might require multiple key blends in a time-consuming and costly process.

Fortunately, with tumble blending equipment that is engineered to meet the requirements of the application, the process can be simplified to produce a precise, homogenous blend containing necessary components and trace elements in the specified amounts. Such blending can eliminate the need for key blends and produce a better distribution of active ingredients.

Limitations of Traditional Mixing Equipment

Traditional equipment such as plow, ribbon and paddle mixers, which use blades or paddles to push material, are limited to moving the material within the confines of their active area. The mechanics force the material bed outward, leaving dead spots inside the vessel where material moves more slowly or remains stationary. A stationary port at the bottom of such machines further isolates the material.

Another issue lies in the positioning of the intensifier bars, which should ideally be in the mixing zone, where every particle passes through. Many times, however, traditional mixers position intensifier bars in dead zones, resulting in material not being fluidized properly and active ingredients getting incorporated throughout the batch.

Traditional mixers can also waste expensive additives. Because additives initially contact only a small portion of material in the vessel, they get absorbed into the material bed, so more additives are usually needed to achieve the desired mix concentration, which increases cost.

Read The Full Article HERE

Nootropics for healthy cognitive function

People in many countries, including the U.S., are experiencing an increased life span.1 However, the aging population aims not just for increased, but optimized, years of life. Paramount to this are strategies to improve cognition or delay age-related cognitive decline. Supporting cognitive function is something that can, and should, be considered, even before the earliest signs of dementia are noticed.

Nootropic, a term coined in 1972 by Corneliu E. Giurgea, Ph.D, refers to a nontoxic substance that enhances learning and memory, facilitates communication between the brain hemispheres and enhances neurological resilience.2 Nootropics are commonly utilized to prevent or support early states of cognitive decline; they are also utilized by those who simply wish to optimize their cognitive function.

Cognitive function can be enhanced in a variety of ways. Studies show high levels of free radicals in the brains of those with cognitive decline.3 Antioxidants that can cross the blood-brain barrier tend to support cognitive function and protect the brain from the expected effects of aging. Vasodilators increase blood perfusion to the brain, enhancing oxygen levels and aiding glucose utilization.4 Substances that support neurotransmitter levels, particularly acetylcholine (ACh), can treat dementia.5 Finally, substances that support neurogenesis and increased neurological plasticity via modulation of brain-derived neurotrophic factor (BDNF) show great promise in enhancing cognitive function.6

Ginkgo bilboa (ginkgo) leaf is a well-known nootropic herb. Ginkgo trees belong to the Ginkgoaceae family, an ancient family cultivated for thousands of years for medicinal use in China. Much of the ginkgo used in research studies is a standardized product (EGb 761) of 22 to 27% flavonol glycosides, 5-7% terpene lactones, and less than 5 ppm ginkgolic acids. Ginkgo increases circulation to the brain, supporting glucose levels and adenosine triphosphate (ATP) utilization, and decreasing free-radical damage. Nootropic effects may also be due to increased levels of BDNF.6 Ginkgo is most effective when used for at least six weeks; long-term dosing is safe if the patient doesn’t have a clotting disorder or using anticoagulants (ginkgo thins the blood and should also be discontinued prior to surgery). Adulteration/contamination of ginkgo can be a concern,7 so analysis should be done on ginkgo sources to ensure a high-quality product.

Bacopa monnieri (water hyssop) is an Ayurvedic herb traditionally used as a medhya rasayana (memory/intellectual enhancer). Water hyssop grows in swampy or marshy areas; the arial portion of the plant is used, making it a very sustainable product. Sometimes referred to as brahmi, water hyssop is often contaminated with Centella asiatica.8 Water hyssop is a potent antioxidant that can cross the blood-brain barrier. Administration is protective against toxic exposure, including tobacco and common environmental contaminants with neurotoxic side effects.9,10 Water hyssop also increases cerebral blood flow and supports ACh levels.9 Additionally, early research seems to indicate enhancement of BDNF.6 Multiple studies have shown water hyssop improves memory acquisition and retention, as well as attention and memory processing. Results are most pronounced after three months of administration; short-term memory improvements are not seen in research studies, although many patients feel subjectively better even with short-term administration.

Read The Full Article HERE

Product formulation with plant-based proteins

The increasing popularity of, and consumer demand for, plant-based foods has created a whole new set of challenges for product developers. Whether creating plant-based foods that eat like their animal protein counterparts or developing great tasting standalone plant-based products, the obstacles can be significant.

Formulating with plant proteins requires a juggling act when it comes to balancing the functionality, sensory impact, nutrition profile, regulatory status and cost impact of the various ingredients. Two main challenges unique to plant proteins include perfecting functional and sensory attributes.

Functional

Animal and plant proteins are very different in their structure and functionality. While animal proteins are fibrillar and fibrous and play primarily a structural role, plant proteins are less organized and are globular and play more of a functional role. This results in differences in analytical measures such as oil- and water-holding capacity, emulsion capacity/stability, and foaming capacity/stability along with corresponding functional differences in gelation, emulsification, water/fat retention, matrix formation, viscosity, etc.

Protein content and quality also differ significantly between animal and plant proteins. Animal-sourced proteins are complete—containing an adequate proportion of each of the nine essential amino acids. Plant-sourced proteins—with the exception of soy—typically are not complete proteins and must therefore be strategically blended with other complimentary proteins to achieve the desired amino acid composition.

Sensory

In addition to structural differences, plant proteins each have their own unique flavor volatiles that often require masking or manipulation. These volatiles can include earthy, grassy, beany, “green,” hay, cardboard and “dirty,” just to name a few. Texturally, plant proteins can differ significantly, with some being dry and chalky, and others being described as gritty or sandy.

In terms of adding flavors to plant proteins, one faces not only the challenges of masking the undesirable flavors mentioned above, but also is challenged with the flavor “dampening” (binding) effect that plant proteins have. Plant proteins will require bolder and more impactful flavors (and possibly a higher usage rate for seasonings and flavors) to compensate for this dampening effect.

While the increasing popularity of food products made with plant proteins does present some new and unique challenges to the product developer, there are flavors, functional raw materials and processing methods that are available to successfully work through these challenges. Given the rapidly increasing consumer demand for new plant-based food products, flavor and functional ingredient suppliers are responding, and are constantly developing new solutions for food and beverage manufacturers.

Read The Full Article HERE

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

1 2 3 4 5 23
ncl-made-in-usa
ncl-fda
ncl-gmp-certified

For more information call (800) 688-5956 or Contact Us for a Free Quote!

También hablamos Español

For a Free, NO HASSLE Consultation or Quote: Simply fill out the form below and Click Send. One of our friendly staff will reply to you promptly. Thank you!