Legal Status

Ephedrine in the USA : Legal Status & Review of FDA Ban

Ephedrine USAProducts containing ephedrine in the USA have been banned since 2004. However, for decades, ephedrine, at its most basic description as a stimulant, was one of the most popular and profitable components found in dietary aides and weight-loss products.

What happened? Why was ephedrine suddenly taken off the market? Since then, has any other suitable alternative or substitute been found to replace the ephedrine ingredient in today’s weight-loss, energy-producing, or diet products?

For years prior to the ban of ephedrine in 2004 (in the US), medical experts, government regulating committees, and health organizations grew increasingly concerned about the number of complaints, medical issues, and side effects caused by dietary or energy-producing products containing ephedrine.

The Food and Drug Administration (FDA) issued one of its first public warnings about side effects and potential issues of use of ephedrine in the summer of 1993. However, it wasn’t until 1997 that the US FDA published their recommendations and rulings on product labeling, dosage, and length of use limitations.

By spring 2000, the FDA withdrew those recommendations based on insufficient evidence to support their suggestions. [1]


  Ephedra Fat Burners
 

Ephedrine in the USA: Why is it Banned?

Over the years, research continued until in early 2003, a white paper was published by the Food and Drug Administration ultimately reporting evidence on the effectiveness and safety of ephedrine. As complaints and reports of alarming side effects continued and increased, the FDA announced its plan to prohibit sales of any dietary supplement that contained ephedrine by December 2003.

In February 2004, the Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, was published in the Federal Register. [2]

The reason for this focused attention was the increasing report of very serious side effects and adverse reactions by users. These negative side effects were not limited to individuals who were obviously misusing, overusing, or abusing the product for faster results. Negative side effects were not limited to older people or those with medical problems. They were also reported in otherwise young and healthy individuals.

The decision to ban ephedrine caused plenty of controversy then, and still does. At the time (1970s to the late 1990s), ephedrine was found in more than 200 over-the-counter products in the United States alone. [3]

One of the most popular products at the time was Metabolife 356 manufactured by Metabolife International. Other top-rated products included Ripped Fuel, manufactured by Twin Labs. Dozens of labs were involved in manufacturing their own ephedrine products with different milligrams strengths as well as usage instructions than others.

How does Ephedrine Work?

Ephedrine is one of the alkaloids found in the more potent ephedra plant species. While ephedrine, scientifically at least, has been identified as a subtype of a mimetic component that affects the central nervous system.

The primary mechanisms of action of ephedrine, the plant, and its parts, have been used for thousands of years to treat a number of ailments, without a more modern understanding of exactly how the ephedrine alkaloids achieved those results.

For example, the ephedra plant, and in turn, its alkaloids, including ephedrine, have been used for approximately 5,000 years in a variety of traditional Chinese medicine (TCM) practices. It’s also been used in India for Ayurvedic treatments, known as traditional Ayurvedic medicine or TAM, and in other places around the world.

Ephedrine has a stimulative effect on the central nervous system as well as many autonomic functions over which we have no control. It also influences, by its stimulative nature, metabolism, metabolic processes, and the cardiovascular system.

How exactly does it work? Ephedrine has the capability of shrinking swollen nasal passages and sinuses. It has this potential because its chemical components trigger reactions in mucous membranes and smooth muscle tissue.

This ability dilates areas of mucous membranes and ‘tunnels’ that make their way through the sinuses and nasal passages – effective in enabling greater oxygen flow into these cavities. It also has an effect on the smooth muscle tissue that lines the nose, the sinus cavity, and the airways that extend down into the lungs (bronchial tubes).

Because of this mechanism of action, ephedrine has the potential to relax or dilate these airways, relieve constriction, and enhance oxygenation or intake of oxygen because of the now widened passages.

Ephedrine was a major component found in many asthma inhalers and used in the treatment of a variety of breathing and lung difficulties such as allergies, sinusitis, bronchitis, and sometimes even COPD or emphysema.

In addition to the ability of ephedrine to widen airway passages is its ability to have much the same effect on blood vessels – in turn increasing the delivery of oxygen and nutrient-rich blood to vessels throughout the body, especially the peripheral blood vessels.

However, because of its mechanism of action and chemical properties, ephedrine behaves in a similar manner to amphetamines, which also have an influence over the central nervous system. The ephedrine has the ability to act as an agonist or trigger for the release of dopamine and norepinephrine, which significantly affect the sympathetic nervous system.

It also has an indirect ability to stimulate adrenergic receptors, which are the same structures in the body that respond to our flight or fight response, increasing cardiovascular output, increasing blood pressure, and decreasing appetite.

Each of these reactions is the body’s way of prioritizing the organ systems and functions necessary for immediate survival.

The traditional medical approach for use of ephedrine was intended to relieve breathing. In historic usage and practice, ephedrine was never utilized as an energy-promoting or weight-loss product. Modern usage of ephedrine focused on its weight-loss and energy producing potential.

Because of its stimulative effects, it is perceived that the increased heart rate and increased metabolism triggers thermogenesis or production of heat in the body. While this is true, thermogenesis is not the same as lipolysis, or more specifically, the breakdown of fat.

Thermogenesis is defined as the protection of heat, especially in the body, such as that produced by oxidation. A number of dietary products today promote a thermogenic effect, or ability to produce heat.

How effective is thermogenesis and weight loss? A number of studies have been conducted in an attempt to answer this very question. One specific study focused on dietary supplemental thermogenic effects on heart rate, blood pressure, calorie expenditure, and its effects on actual weight loss.

While it did determine in one small study that young and healthy subjects (five male and five female) did achieve a boost in energy for approximately two to three hours, the subjects also experienced elevated heart rate and elevated systolic blood pressure as a result. [4]

Most have noted a boost in effects in regard to energy production and thermogenesis when accompanying dietary supplements with caffeine. It is perceived that increased energy expenditure results in decreased stores of body fat.

It has also been noted that herbal supplementation that does promote thermogenic effects in combination with caffeine can enhance resting metabolic rate for several hours following consumption. Such effects will also likely be accompanied by the aforementioned negative side effects of elevated heart rate, blood pressure, and additional negative side effects.


  Ephedra Extract For Sale
 

Ephedrine in the USA: Substitutes/Alternatives

Since the ban of ephedrine in the USA since 2004, a number of nutritional and dietary supplement manufacturers have sought alternatives for the ephedrine component and its stimulative effects on the body for their products.

An increasing number of such ephedrine alternatives grown in popularity because of the similarity of their mechanisms of action to ephedrine. Among them include:

  • Bitter Orange (citrus aurantium) – aka p-synephrine
  • Yerba Mate – primarily functions as an appetite suppressant, and there is some conjecture that caffeine can enhance its effects. Some research has determined that the ability of this herbal ingredient to increase lipolysis or increase energy expenditure may be negligible.
  • Phenylethylamine – acts much as a mood enhancer, and has been studied in clinical environments for the relief of depression. It’s believed that its primary mechanism of action is related to the release of dopamine, as well as a potential appetite suppressant. This herbal ingredient might also have the potential to trigger lipolysis due to its association with the ability to stimulate catecholamine delay and release reuptake. [5]

The issue with some ephedrine substitutes is that they behave much like ephedrine did, and therefore can contribute to the same risks of use. A number of drugs with sympathomimetic or stimulative properties are being substituted for ephedrine in products today. These are known as adrenergic amines and they influence the sympathetic system of the body.

The body’s reaction to drugs that affect the sympathetic nervous system processes includes more than our fight or flight or adrenaline surge response. It can have more than an effect on our metabolism, our fat-burning potential, and energy production.

To achieve each of those benefits from a dietary supplement, it must also alter how our metabolic system, digestion, and heart rate function.

A number of negative side effects have been associated with Bitter Orange (p-synephrine). Consumers should also be aware that just because ephedrine in the USA has been banned, the number of ephedrine substitutes are found in today’s popular weight loss and energy-producing supplements that can also trigger the same reactions in the body as the ephedrine.

The FDA continues to monitor these substitutes, provide warnings, and in some cases, has banned some of these later substitutes as well.

Of note, Citrus aurantium is currently garnering attention by the FDA in regard to potential cardiovascular toxicity. [6]

Finding Ephedrine in the USA for Sale

Finding ephedrine for sale or a product containing ephedrine in the USA may prove challenging. Of course, as with any drug, prescription or over-the-counter, banned substances can be found, mainly online and from countries that still allow the ephedrine alkaloid in dietary or weight-loss products.

What About Dosage Recommendations?

In a nutshell, dosage recommendations or guidelines for use of ephedrine products are literally all over the map. It depends on the milligram strength of the product and its additional ingredients such as stimulants.

The half-life of ephedrine ranges three to six hours, but every individual using it may experience more or fewer benefits as well as side effects with use. A number of factors can also influence the half-life of ephedrine including:

  • Age
  • Weight
  • Body composition
  • Whether it’s used with any other stimulants, including caffeine
  • Frequency of use
  • Milligram strength
  • Overall health and fitness level

While ephedrine in the USA has been banned, ephedra with the alkaloids removed has not. Even the lower dosage effect in such products available today, ranging from 10 mg to 27 mg and up to 65 mg or more, contain different components – and potential side effects. The base form of the ephedra – even with the specific alkaloids removed (at least in the US) – can also have an effect on potency.

Not all ephedra plant species are created equal, with some being more potent than others. Individuals purchasing ephedra containing ephedrine as an alkaloid in addition to the others found in the plant from various countries around the world will find different states of quality, potency, and recommendations for use.

It is generally suggested that an individual who is not familiar with ephedra or ephedrine start at the lowest dosage possible to gauge the body’s reaction to it. This is especially important if that individual is taking any prescription strength or other over-the-counter drug to treat a medical condition.


  ECA Stack
 

Safety Issues with Ephedrine

A number of safety issues have been and continue to be associated with use of ephedrine, especially in higher dosages. Potential users of ephedrine should be aware that even at lower doses, and especially a new user, a number of side effects and adverse reactions have occurred.

The serious side effects and adverse reactions associated to usage of ephedrine products is not limited to individuals with health issues, for those who are middle-aged or older. A majority of the reports and studies written up in medical journals and case studies have been young, otherwise healthy individuals in their 20s or 30s.

The most common side effects associated with ephedrine, and which won’t necessarily cause long-term damage, but frustration to users, include but is not limited to:

  • Headache (often severe)
  • Jitters (most commonly noted as a feeling of jumpiness, or visual hand tremors)
  • Difficulty sleeping (some experience insomnia) caused by the stimulative effects of ephedrine
  • Increased irritability/anxiousness/nervousness
  • Dizziness
  • Heart palpitations
  • Nausea, sometimes accompanied by vomiting
  • Urinary retention

More serious side effects can also affect users at a variety of milligram dosages, regardless of the length of use. Some of the more serious and potentially life-threatening adverse reactions that may occur with use of ephedrine include:

  • Tachycardia (accelerated heart rate)
  • Cardiac arrhythmia (irregular heart rate)
  • Myocardial infarction (heart attack)
  • Seizures
  • Stroke
  • Psychosis

In addition to the side effects of ephedrine alone are the potential for side effects caused by interactions with other drugs (over-the-counter as well as prescription strength).

No matter where you get your ephedrine, be aware of the kinds of drugs they can interact with. A number of interactions may occur for any person taking drugs or undergoing some type of treatment for hyperglycemia. Interaction potential is also possible in regard to its hypertensive effects, as well as its ability to prolong QT intervals.

QT intervals are measurements of timing involved in the electrical cycle of cardiovascular function. For example, a longer QT interval can contribute to heart rhythm disorders such as irregular heart rhythm or arrhythmia.

Some of the most common side effects associated with longer QT intervals can include but are not limited to fainting, which occurs because the brain does not receive adequate blood flow.

Fluttering feelings and fainting may commonly occur during periods of emotional stress or physical activity. An even more serious symptom of longer QT intervals (known as long QT syndrome) is explicable or idiopathic sudden cardiac arrest, which occurs when the heart stops beating for no obvious reason. [7]

It’s commonly perceived that an otherwise healthy and young individual will rarely experience such a severe side effect, which is true for the most part. It can happen, even with use of over-the-counter medicines and herbal products.

Before using ephedrine for any reason, check with medical resources or drug databases to determine which over-the-counter, prescription, or herbal ingredients to avoid with use, or those that are contraindicated with use.

Does Ephedrine in the USA Have a Future?

The banishment of ephedrine in the USA is not likely to be lifted. Newer drugs have gradually replaced ephedrine in a number of medications, reducing the likelihood of finding products with ephedrine.

Among the most common products still available in some locations are bronchial inhalers or asthma medications such as Primatene, which does contain some ephedrine. Primatene ephedrine can be found in tablet form, but the mist inhalers have been discontinued in the USA.

Because so many of today’s dietary weight loss or energy producing products have already found other natural components, chemical products, or synthesized components to replace the ephedrine, the likelihood of finding original products such as Metabolife with ephedrine is also extremely unlikely. (If you do, it likely predates the ban.)

In addition, athletes looking for energy-promoting products or ephedrine substitutes found in today’s products should always check with the International Olympic Committee or the World Anti-Doping Agency, or sporting association to determine whether those supplements or herbal ingredients are on their own list of banned substances.

The list of banned substances by WADA continues to grow, but those interested can look to the website for substances that are prohibited in competition, those that are prohibited in particular sports, or those that are prohibited at all times. Among that list include [8]:

  • Anabolic agents
  • Beta 2 (β2) agonists
  • Hormone and metabolic modulators
  • Peptide hormones
  • Growth factors and related substances and mimetics
  • Diuretics and masking agents

Ephedrine is defined as a stimulant, and is therefore prohibited in competition. So too is synephrine, likened to epinephrine or adrenaline. While this list does not (at this time) contain Yerba Mate or Yohimbe (Yohimbine), it is always recommended that a potential user check with their own sporting association, or organization guidelines in regard to drugs and supplements to determine usage regulations or limitations.

Conclusion

Ephedrine in the USA, while enjoying a few decades of being one of the most popular and seemingly beneficial weight loss compounds found in products, is no longer the “go to” stimulant that it used to be.

While the controversy regarding its banishment is still argued on bodybuilding forum boards, weight loss discussion groups, and those looking for the “kick” those ephedrine products gave them in regard to energy promotion, it is unlikely that ephedrine in the USA will ever be allowed again.

A number of studies and clinical trials attempting to specifically and definitively define the efficacy of ephedrine for weight loss, ephedrine for energy, or ephedrine for moderate to significant benefits of use for thermogenesis or lipolysis have deemed that while it may provide a very temporary (hours) effect, its potential side effects more than outweigh benefits.

In regard to energy, consumers should be aware that combining more than one stimulant in a single product or combining several products containing stimulative ingredients, can and does increase the risk of negative side effects and adverse reactions.

When looking for ephedrine for sale in countries outside of the US, proceed with caution. False labels, inadequate information regarding milligram strength of all of a product’s components, and lack of information regarding safe dosage and length of use is common.


  Ephedra Fat Burners
 
Read This Next
Ephedrine Effects
Top 13 Positive and Negative Ephedrine Effects [Review]
What are the positive and negative effects of ephedrine and is this stimulant worth it for weight loss? Ephedrine is well-known for having the ability to modestly increase fat loss results...
ECA Stack Review
How to Take an ECA Stack [BEST Dosage Schedule + Ratio]
What is the right way to take an ECA stack for weight loss? An ECA stack refers to a combination of ephedrine, caffeine and aspirin. This stack has been a favorite of bodybuilders who take it to burn fat, increase energy and get ripped.
Is Ephedra Legal
Is Ephedra Legal in 2018? Supplements You Can STILL Buy
Is ephedra legal since the ban on ephedrine alkaloids by the US FDA in 2004? Confusion has reigned over ephedra and ephedrine legal status, not only in the United States, but the legalities and other countries.
Ephedra Diet Pills
Ephedrine Fat Burners: The REAL Story Behind the Ban
Ephedrine fat burners have been banned for over a decade but remains the most sought-after stimulant by bodybuilders and athletes. Ephedrine puts your body into a fat-burning state by suppressing the appetite and...
Ephedrine for Weight Loss
Ephedrine for Weight Loss- How EFFECTIVE is it Really?
Research shows that ephedra can boost your metabolism and support fat loss. In one research study, an individual lost 145 lb. over 13 months with the help of ephedrine and a low-calorie diet.
Ephedrine Alternatives
4 BEST Ephedrine Alternatives for Weight Loss [Legal Diet Pills]
What are the best ephedrine alternative products available today that can replace the alkaloids banned from ephedra dietary supplements in 2004?
References
Previous post

Ephedrine Reviews, Before & After Results and Success Stories

Next post

Do Ephedra Diet Pills Really Work? Review, Results & Ratings

No Comment

Leave a reply

Your email address will not be published. Required fields are marked *