Call Us Toll Free (800) 688-5956

L-Histidine: The Nerve-Cell Protecting Amino Acid

L-Histidine at a Glance

L-Histidine is a conditionally essential amino acid and is a part of one of the 23 proteinogenic amino acids. It is necessary for the formation of the myelin sheath, which surrounds all nerve cells and protects them from damage within the body. 

Histidine also protects the body from radiation damage, assists with lowering blood pressure, promotes the recovery process after injuries and helps to boost the immune system. It is also required for the production of histamines.

How It Works


Histidine is the precursor to the amine histamine which is necessary for inflammation, immunity, digestion, and sexual function. It also modulates wakefulness, learning, memory, and emotions in the brain.

It is also required for the formation of carnosine, a dipeptide found in skeletal muscle that also helps slow down degenerative diseases and improves muscle performance. 

Moreover, it also helps reduce inflammation and oxidative stress while regulating feeding behavior, energy metabolism, and the levels of elements such as iron, copper, molybdenum, zinc, and manganese in the body.

Histidine is also important in producing red blood cells and maintaining normal hemoglobin levels in the body. Moreover, it can also regulate the pH value of blood. 

It also protects the skin against UV radiation through producing urocanic acid, a chemical absorbs UV light.

Histidine Benefits

  • Histidine supplementation can help fight chronic diseases such as heart disease. This amino acid is converted to carnosine in the body which has anti-inflammatory, antioxidative, anti-glycating, anti-ischemic, and chelating properties.
  • It can also help improve mental performance and cognitive health due to its ability to form the myelin sheath and protect cells from oxidative damage.
  • Studies have shown that this amino acid can help reduce oxidative stress, lower inflammation, and improve insulin sensitivity in obese adults with metabolic syndrome.
  • Histidine, through its histamine-producing function, can also help protect and heal the skin. It can help reduce dryness and irritation by increasing antioxidant activity, neutralizing free radicals, reducing inflammation, and boosting UV protection.
  • Supplementation of this amino acid can also reduce the duration of viral and bacterial infectionsthanks to its ability to regulate responses of the immune system and produce histamines. 

Dosage Recommendations for L-Histidine


According to the World Health Organization, the recommended daily intake of histidine is 8 to 12 mg per kg of body weight in adults. You can take histidine supplements to reverse deficiency and treat conditions such as poor kidney function and anemia.

You can also consume high-protein food such as poultry, beef, protein powders, fish and seafood, eggs, soybean products, legumes and beans, whole grains, cauliflower, potatoes, and corn to make sure that you meet your daily recommended intake.

Safety Considerations for L-Histidine

Taking histidine above the recommended dosage can cause side effects such as muscle weakness, drowsiness, and fatigue, headaches, digestive issues like nausea and loss of appetite, depression, and poor memory.

If you have a kidney or liver disease, you should consult with a doctor before consuming large amounts of amino acids.

L-Threonine: The Collagen-Boosting Amino Acid


Threonine is an important part of various proteins in the body and plays a necessary role in the formation of elastin and collagen which both help with healthy skin and wound healing as well as tooth enamel. It enhances immunity, cell immune defense function, and helps prevent fatty build-up within the liver. 

The body synthesizes threonine into glycine which aids in the reduction of constant unwanted contractions of the muscles or spasticity.

It can be sourced from a wide variety of protein-rich food including organic meats, wild-caught fish, dairy, cottage cheese, eggs carrots, bananas, sesame seeds, pumpkin seeds, kidney beans, edamame, spirulina, and lentils. There are also dietary supplements containing this amino acid that you can take to increase your intake of this nutrient.

L-Threonine Benefits

  • L-threonine is known for its ability to support muscle and bone strength thanks to its role in collagen and elastin production. It supports proper elastin function which helps your skin, tendons, and ligaments resume its shape after stretching or contracting.
  • It also accelerates wound healing. Threonine is metabolized from your body’s tissues following an injury that triggers the production of collagen which the body then uses to heal damaged tissues.
  • L-threonine also plays a role in maintaining a healthy liver by regulating fat metabolism and facilitating lipotropic function. It prevents the build-up of fat in the liver and protects the liver from failure.
  • This amino acid also aids in keeping your digestive tract healthy. It produces a mucus layer that protects it from damaging digestive enzymes resulting in improved gut function. 
  • As a precursor to glycine, L-threonine also plays a role in alleviating anxiety and mild depression. It aids in the improvement of sleep, mental performance, mood, and memory.

Dosage Recommendations for L-Threonine


L-threonine is available in 500-mg capsules that can be taken up to three times daily. The most common recommended dose for this supplement is 500 mgt o 1000 mg. If you’re taking it to address deficiencies, it’s best to consult a physician beforehand.

While Threonine deficiency in people is rare, people with an unbalanced diet may be prone to low levels of this amino acid in their bodies. Without enough L-threonine, people may experience symptoms such as digestive problems, irritability or emotional agitation, confusion, increased liver fat, and poor nutrient absorption.

Safety Considerations for L-Threonine

Taking L-threonine is considered safe when taken in appropriate amounts. However, overconsumption of this supplement may cause side effects such as headache, nausea, upset stomach and skin rash.

People taking NMDA antagonists often used to treat Alzheimer’s disease should avoid using this supplement.

L-Methionine: An Amino Acid for Healthy Bones, Skin, Hair, and Nails

L-Methionine is a sulfur-containing essential amino acid that plays a vital role in tissue growth and repair as well as in the growth of new blood vessels. It is part of many biochemical reactions, including the production of S-adenosylmethionine (SAM or SAMe). SAM is partly involved in the synthesis of creatine, epinephrine, and melatonin along with several other substances.

It also promotes healthy skin, hair, and nails and is involved in the body’s natural detoxification process by protecting cells from pollutants and slowing down cell aging. Moreover, it is also crucial for the absorption and bioavailability of selenium and zinc.

How It Works

Methionine plays a crucial role in the metabolism and health of humans. It is the substrate for other amino acids such as cysteine and taurine as well as for compounds like SAM-e and the antioxidant glutathione.

It also contains sulfur and can produce other sulfur-containing molecules that the body uses to make proteins in the body. It also plays an important part in the growth of new blood vessels. 

L-Methionine Benefits

  • Methionine helps improve athletic performance by building bone strength. It adds bone volume, mineralization, and mineral content which improves your ability to perform high-intensity physical activities. 
  • It aids in weight loss through its role in creating creatine in the body. It helps improve athletic performance as well as the muscle to fat ratio in the body.
  • When combined with other B vitamins, methionine may help reduce the risk of colorectal cancer.
  • Studies have also shown that patients treated with l-methionine for two weeks to six months can lower tremors in Parkinson’s patients. It also helps prevent the effects of dopamine damage and dopamine loss.

Dosage Recommendations for L-Methionine

Generally, the body can produce its own methionine. However, supplementation may be necessary for people experiencing certain illnesses. This includes Parkinson’s disease, drug withdrawal, schizophrenia, radiation, copper poisoning, asthma, allergies alcoholism, liver damage, and depression.

According to the World Health Organization, the daily recommended dosage for l-methionine depends on a person’s age. For pre-school children ages 2 to 5, the recommended dose is 27 mg/kg of body weight per day. School-aged children ages 10 to 12 should be taking 22 mg/kg of body weight per day. Meanwhile, adults over 18 years of age need 12 mg/kg of body weight per day.

You can source it from your diet. Some food with the highest concentrations of L-methionine includes egg whites, chicken halibut, tuna, cod, turkey, seaweed, spirulina, sesame seeds, and oats. There are also dietary supplements available in the market.

Safety Considerations for L-Methionine

Overconsumption of methionine can lead to minor side effects. This includes dizziness, sleepiness, and changes in blood pressure. While the side effects are considered minor, extremely high doses could be dangerous.


Isoleucine at a Glance

Isoleucine is a branched-chain amino acid (BCAA) present in dietary protein. It is often used in amino acid mixes usually taken by weightlifters, athletes, and people who are physically active.

As one of the building blocks of life, isoleucine is responsible for manufacturing proteins that your body uses to build tissues and lean muscles. It also contributes to the repair, recovery, and rebuilding of muscles after intense physical activity.

What sets it apart from other BCAAs is its ability to boost energy during intense physical activities. It fuels your skeletal muscles when you workout or partake in sports activities.

It is an essential amino acid that the body cannot produce on its own and should, therefore, be sourced through your diet or through supplements. 

Some food sources of isoleucine include eggs, dairy products, spirulina, turkey, chicken, lamb, grass-fed beef, seafood, watercress, chard, lentils, black beans, pinto beans, and sesame seeds. You can also take dietary supplements to fulfill your daily recommended dose of isoleucine. 

How It Works

It is also known for its role in physiological functions such as wound healing, stimulating immune function, and promoting the secretion of several hormones. It also plays a role in the synthesis of hemoglobin which helps carry oxygen from the lungs to the body’s tissues.

This amino acid plays a key role in the regulation of energy and blood sugar levels. It promotes glucose uptake in the muscle cells where it is broken down by the body into an efficient fuel source. This energy is the key to  enhancing athletic performance. 

Isoleucine Benefits

  • Isoleucine lowers glucose levels in the body. A study in Japan concluded that oral administration of isoleucine helps decrease the levels of glucose in blood plasma. This stimulates the uptake of insulin-dependent glucose in skeletal muscles.
  • It also helps reduce skeletal muscle damage resulting from intense physical activity. Studies have shown that this BCAA helps reduce muscle soreness especially when taken before a workout.
  • Research also suggests that BCAAs reduce post-workout fatigue and boost athletic performance during exercise. It limits the uptake of tryptophan in the brain resulting in the reduction of exhaustion and in the improvement of physical and mental performance.

Dosage Recommendations

The recommended daily dose for isoleucine supplements is 1000 mg to 2000 mg per day. If your goal is to build muscle mass, you might want to consider taking it with other BCAAs at a ratio of 2:1:1 valine, leucine, and isoleucine.

Safety Considerations

Excessive intake of BCAAs like isoleucine may lead to nausea, vomiting, diarrhea, stomach bloating, fatigue, and loss of coordination.

It is also not recommended to take high doses of amino acids for long periods since it can lead to negative nitrogen balance in the body.

If you are pregnant or breastfeeding, you should not take this supplement.

As with any dietary supplement, it’s best to consult a physician before taking isoleucine.

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


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


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

  • 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

1 2 3 4 5 6 23

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!