NAC Banned From Amazon, FDA Says It's Medication

N-acetylcysteine (NAC) has made the news, not because scientists discovered a new health benefit, but because the U.S. Food and Drug Administration decided after 57 years of over-the-counter sales the compound is now a medication that requires a physician’s prescription. Like ibuprofen (Advil)1 and acetaminophen (Tylenol),2 NAC has been available both over the counter and in prescription form.3 Doctors prescribe ibuprofen, acetaminophen and NAC in the hospital for specific uses. Historically, people could purchase all three over the counter. Recently, the FDA decided that, unlike ibuprofen and acetaminophen, NAC should be removed from public sale. NAC is an antioxidant compound made up of three amino acids — glutamic acid, glycine and cysteine.4 However, N-acetylcysteine is available only in supplement form and cannot be found as such in foods. But the precursors to NAC can be found in foods high in cysteine, including pork, beef, chicken, eggs, swiss cheese and sunflower seeds.5 NAC is valued as a precursor to glutathione, also called the “master antioxidant.”6 NAC is useful in the treatment of acetaminophen poisoning, helping to lower the risk of mortality and liver damage. Despite a long history of concurrent use as an over-the-counter supplement and prescription medication in the hospital, the FDA has not been interested in removing the status as a dietary supplement — not, that is, until recently when NAC showed promise in the fight against COVID-19.7 FDA Invokes a Legally Questionable Drug Exclusion Provision The law defines dietary supplements specifically. In the U.S. code Title 21,8 the law uses specific definitions of what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a “medication” is illegal under the law. Attorney Dan Soper9 writes that under Title 21 §321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision. In the code, it defines what a dietary supplement is not. Specifically, it says that a dietary supplement (article) does not include: An article approved as a new drug, certified as an antibiotic, or licensed as a biologic under specific sections of the title. An article authorized for investigation as a new drug, antibiotic or biologic for which there have been substantial clinical trials and for which the existence of all of these investigations has been made public. In addition, the article was not before approved, certified, licensed or authorized, marketed as a dietary supplement or as a food “unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.” According to Soper,11 the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal. In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.12 In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease. Their argument was there was “no evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.”13 In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application. The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD. After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.14 Soper postulates15 that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC. Others Hold the FDA Is Using a ‘Legally Invalid’ Position In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA).16 This gave the FDA regulatory authority and enforcement tools to protect consumers. The Council for Responsible Nutrition (CRN) supports enforcement of the law,17 but the recent FDA move against NAC appears to step well beyond the letter and intent of the Act. December 4, 2020, the CRN wrote an open letter18 to Steve Tave, director of the FDA’s office of dietary supplement programs, and sent a copy to Douglas Stearn, deputy director for regulatory affairs. In the eight-page letter, the CRN outlined why they believe the positio

NAC Banned From Amazon, FDA Says It's Medication

N-acetylcysteine (NAC) has made the news, not because scientists discovered a new health benefit, but because the U.S. Food and Drug Administration decided after 57 years of over-the-counter sales the compound is now a medication that requires a physician’s prescription.

Like ibuprofen (Advil)1 and acetaminophen (Tylenol),2 NAC has been available both over the counter and in prescription form.3 Doctors prescribe ibuprofen, acetaminophen and NAC in the hospital for specific uses. Historically, people could purchase all three over the counter.

Recently, the FDA decided that, unlike ibuprofen and acetaminophen, NAC should be removed from public sale. NAC is an antioxidant compound made up of three amino acids — glutamic acid, glycine and cysteine.4

However, N-acetylcysteine is available only in supplement form and cannot be found as such in foods. But the precursors to NAC can be found in foods high in cysteine, including pork, beef, chicken, eggs, swiss cheese and sunflower seeds.5 NAC is valued as a precursor to glutathione, also called the “master antioxidant.”6

NAC is useful in the treatment of acetaminophen poisoning, helping to lower the risk of mortality and liver damage. Despite a long history of concurrent use as an over-the-counter supplement and prescription medication in the hospital, the FDA has not been interested in removing the status as a dietary supplement — not, that is, until recently when NAC showed promise in the fight against COVID-19.7

FDA Invokes a Legally Questionable Drug Exclusion Provision

The law defines dietary supplements specifically. In the U.S. code Title 21,8 the law uses specific definitions of what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a “medication” is illegal under the law.

Attorney Dan Soper9 writes that under Title 21 §321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision. In the code, it defines what a dietary supplement is not. Specifically, it says that a dietary supplement (article) does not include:

  • An article approved as a new drug, certified as an antibiotic, or licensed as a biologic under specific sections of the title.
  • An article authorized for investigation as a new drug, antibiotic or biologic for which there have been substantial clinical trials and for which the existence of all of these investigations has been made public.

In addition, the article was not before approved, certified, licensed or authorized, marketed as a dietary supplement or as a food “unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.”

According to Soper,11 the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal.

In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.12 In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease.

Their argument was there was “no evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.”13 In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application.

The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD.

After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.14 Soper postulates15 that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC.

Others Hold the FDA Is Using a ‘Legally Invalid’ Position

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA).16 This gave the FDA regulatory authority and enforcement tools to protect consumers. The Council for Responsible Nutrition (CRN) supports enforcement of the law,17 but the recent FDA move against NAC appears to step well beyond the letter and intent of the Act.

December 4, 2020, the CRN wrote an open letter18 to Steve Tave, director of the FDA’s office of dietary supplement programs, and sent a copy to Douglas Stearn, deputy director for regulatory affairs. In the eight-page letter, the CRN outlined why they believe the position the FDA has taken is “legally invalid.”19

In December 2020, a journalist from Natural Products Insider20 outlined the arguments CRN used in their letter to Tave, stating why the FDA’s actions were not legally defensible. The points the CRN made included:

Through a Freedom of Information Act request, CRN learned the FDA's claim that NAC had been approved as a drug in 1963 was nothing more than a handwritten notation. The CRN notes this raises questions about the reliability of the record, true approval date and who made the notation.

The 1963 handwritten notation was for an inhalation drug. However, the code clearly states the chemical cannot be called a dietary supplement if the "article" is the same as the drug. In this case, the FDA is asserting an inhaled drug is the same as an oral supplement. Steve Mister, president and CEO, and Megan Olsen, CRN associate general counsel, wrote:21

"Further, a dietary supplement, by definition, must be “a product that ... is intended for ingestion.” Because of this limitation, a dietary supplement would, by its very nature, differ significantly in the route of administration and dosage form from an inhaled drug.

Such significant differences, which will affect a substance’s impact on the human body, must preclude an inhaled ingredient from being considered the same “article” as an orally ingested ingredient."

The CRN found records to suggest that NAC was not approved for drug use until 2016, "well after dietary supplement companies had been marketing NAC as a supplement."22

The FDA's interpretation of the law also conflicts with “the presumption against statutory retroactivity,” which Mister and Olsen go on to say, "Even if FDA records reliably demonstrated drug approval before 201(ff)(3)(B)(i) was enacted, it is a well-established canon of statutory interpretation that legislation shall not be read to have a retroactive effect on private rights unless Congress expresses a clear, unambiguous intent to the contrary."23

The CRN also argues that the FDA failed to explain the policy change before sending warning letters to several NAC manufacturers in July 2020. Mister and Olsen wrote:24

“In response to the extensive history of NAC being treated by FDA as a dietary supplement, manufacturers have invested substantial resources to develop hundreds of such products, and thousands of consumers have come to rely on such products to meet their daily nutritional needs.

Now, FDA has decided to not only change its decades-long policy, but to do so through the issuance of warning letters that fail to provide any reasonable explanation for this consequential policy shift.”

Lastly, the CRN maintains the FDA cannot enforce the policy because they exhibited a lack of diligence, writing:25

"First, FDA’s decades-long delay in bringing enforcement action against manufacturers of dietary supplements containing NAC indisputably resulted from a lack of diligence by FDA, rather than an unawareness that these products were on the market.

In fact, there is ample evidence that FDA has long been aware that these products are on the market, and that FDA has actively considered — and failed to object to — structure/function and qualified health claim petitions regarding products containing NAC. Thus, FDA’s long-delayed enforcement against these products resulted from the Agency’s own lack of diligence."

In an email to Natural Products Insider, Mister said:26

“CRN is firmly committed to protecting our members’ interest in this matter to sell a lawful ingredient. FDA’s warning letters on NAC issued earlier this year are not final agency actions, but rather should be viewed as the opening salvo, inviting those with sound legal arguments to respond and present an opposing point of view, which we are doing.

CRN is optimistic that FDA will closely consider the legal argumentation we have laid out and evaluate its initial position regarding NAC in light of these arguments.”

Why Is the FDA Taking Aim at NAC?

Using the Drug Exclusion Provision on CBD may have opened the door for the FDA to make similar claims against NAC, but there is still the question of timing. Why has the FDA chosen to target NAC now? In the past the provision was used inappropriately in three instances to protect the finances of pharmaceutical companies, and it is likely the motivation to ban NAC as a supplement has the same roots.

As pulmonologist Dr. Roger Seheult succinctly explains in this MedCram video, NAC is a crucial chemical compound necessary to reduce the oxidative stress associated with severe COVID-19 infections and thus may significantly impact the sales of antiviral drugs. And, without severe disease, is there truly a need for a vaccine?

Nine months after the FDA issued warning letters with their position that NAC supplements could not legally be sold, Amazon began removing products containing the supplement.27 In 2020, Amazon adopted polices to improve the quality of the supplements sold on their platform after knock-off dietary supplements were found28 and NOW Health Group identified inferior quality supplements from third-party lab tests.29

Amazon did not respond to Natural Products Insider30 to explain why the products were being removed from the platform. One long-time public relations professional in the industry postulated it may have been a result of significant turnover in Amazon's regulatory staff that prompted the move if the new staff believed selling NAC made the company vulnerable.

More Health Benefits of N-acetylcysteine

NAC supplements are well absorbed and can effectively increase levels of glutathione in the body.31Glutathione deficiency is a key contributor to oxidative stress.32 In turn, oxidative stress contributes to the pathogenesis of several diseases such as liver disease, Alzheimer's disease, Parkinson's disease, cancer, heart attack and diabetes.

NAC contributes cysteine, which one study33 found is inversely associated with the risk of stroke in women. Two papers34,35 concluded that NAC shows promise in the treatment of psychiatric conditions, including addiction, compulsive disorders, schizophrenia and bipolar disorder. The treatment may benefit those whose condition has not responded to drugs and medication.

One team of scientists36 presented a review on different applications NAC may have in a variety of health conditions. This includes reducing insulin resistance and providing a therapeutic approach in the treatment of polycystic ovary syndrome.

Based on evidence, they hypothesized that NAC may reduce the number of premature births and recurrent pregnancy losses by exerting an anti-inflammatory effect in women who have bacterial vaginosis, a risk factor of preterm delivery and low birth weight.

They found there were positive influences that NAC exerted in patients who have ulcerative colitis, including decreasing oxidative stress, lowering cell apoptosis and improving recovery in the colon. Lab studies and animal models have demonstrated NAC can protect normal cells from radiation therapy and chemotherapy but does not protect cancer cells.

NAC has preventive effects against airway hyperresponsiveness in animal studies using acute exacerbation of asthma. In their review, they found NAC was “safe and well tolerated” without considerable side effects.37

Source : Mercola More   

What's Your Reaction?

like
0
dislike
0
love
0
funny
0
angry
0
sad
0
wow
0

Next Article

6 Top Tips To Encourage Hair Growth

The loss of your hair is a painful thing to witness and you likely want to find a remedy to stop hair loss and help your hair to grow back fast.More

6 Top Tips To Encourage Hair Growth

Written By Finnegan Pierson / Reviewed By Ray Spotts

Thinning hair is a problem faced by both men and women. There are several reasons why someone would start to lose their hair. Sometimes the loss happens in noticeable patches and bald spots and sometimes there is simply thinning all over the whole scalp. Either way, the loss of your hair is a painful thing to witness and you likely want to find a remedy to stop hair loss and help your hair to grow back fast.

Destress

One of the top causes of hair loss, aside from medical reasons, is stress. When you're stressed out your body tends to focus on the more important aspects of functioning, and growing a healthy head of hair is not one of them. Stress can be both internal and external. When you are emotionally stressed, it will manifest in physical ways. Environmental stress will also have an impact on the quality of your hair.

You can help eliminate stress from your surrounding by doing your part to reduce energy emissions by going with solar energy. Your wallet will also thank you when you see the reduced energy costs. Schedule to keep everything in good working order and you will have a consistent energy source to power your hairdryer and lower your stress. 

Stimulate Your Scalp

A good scalp massage is a great idea to not only relax you but to help get the blood flowing to your hair follicles and support hair growth. Take a few minutes to massage your scalp when you're washing your hair or as an evening relaxation technique before bed.

Feed Your Hair

The foods that you eat will definitely have an effect on your body, including the appearance and feel of your hair. Protein is an important nutrient that you need to grow your hair, as are collagen and omega-3s. 

You can get collagen by drinking bone broth. This is a powerful remedy that will improve your overall gut health and well-being at the same time as nourishing your hair. A good source of omega-3s can be found in salmon and other fatty fish. These fats help feed your hair and encourage growth and strength. Other good sources of quality fats can be found in avocados, nuts, and seeds.

Take a Supplement

If your hair needs a little extra help, then you may want to consider taking a collagen or biotin supplement. These are some of the essential nutrients that your hair needs to stay strong and continue to grow long. Another good vitamin that can help out is vitamin C because of its ability to eliminate free radicals that can damage your hair.

Choose Hair Products Carefully

Many shampoos and other products contain chemicals or sulfates that can cause damage to your hair and scalp. Pay attention to the ingredient list and when possible, opt for natural products.

Castile soap is a great alternative to regular shampoos, or you can also wash your hair with diluted baking soda followed by a vinegar rinse. Add a few drops of your favorite if you like. Peppermint or rosemary are proven to help stimulate hair growth by cleansing the scalp and improving circulation.

Style Responsibly

Using too much heat to style your hair can cause split ends and dryness. Give your hair a break once in a while and stay away from the curling irons and hairdryers by finding styles that you enjoy where you can let your hair dry naturally.

Another thing to keep in mind is that a too-tight hairstyle can also lead to breakage and hair loss. Pulling your hair up into a ponytail or a bun daily can have a negative effect. If you do pull your hair back, make sure that it's not too tight and that the band that you use is comfortable and not pulling at your scalp.

When you start to pay attention to your environment and how you treat your hair, you can make some good changes that will improve your hair quality and encourage it to grow. With a little time and support, you can start to get your hair back to looking and feeling fantastic.

Subscribe to our  newsletter for more information about . If you are looking for more health resources check out the  

Written By:

Finnegan Pierson loves business and has a passion for Health and technology. Even more interesting is the combination of the two. As a freelance writer, Finn hopes to influence others so they can have positive life experiences.

Reviewed By:

Founder Ray Spotts has a passion for all things natural and has made a life study of nature as it relates to health and well-being. Ray became a forerunner bringing products to market that are extraordinarily effective and free from potentially harmful chemicals and additives. For this reason Ray formed , a company you can trust for clean, effective, and healthy products. Ray is an organic gardener, likes fishing, hiking, and teaching and mentoring people to start new businesses. You can get his book for free, “How To Succeed In Business Based On God’s Word,” at .

Photo by Tim Mossholder on Unsplash

Source : Trusted Health Products More   

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.