Legal Status

Was the FDA Ephedra Ban Lifted? Legal Status of Ephedrine Supplements

FDA Ephedra BanDid the FDA lift its ban on ephedra dietary supplements? Why do so many supplements and energy pills continue to advertise this ingredient if it is banned?

Many people are confused about whether the FDA actually banned ephedra or ephedrine and what the current legal status of these products is. Some clarification is required.

In 2004, the FDA issued a ruling stating that they would no longer allow ephedrine alkaloids to be included in dietary supplements. However, they would continue to allow the inclusion of ephedrine HCL and sulfate in pharmaceutical drugs, such as over-the-counter cough remedies.

This ban only applied to the sale of certain types of ephedra diet pills, namely those ones that contained ephedrine or pseudoephedrine. Not all forms of the ephedra plant extract contain these alkaloids, so not all forms of supplements are banned.

In this article, we will discuss more about the history of the FDA’s ephedrine ban, the current legal policy and which forms of this ingredient that can still buy. Click here to buy ephedra supplements online legally without a prescription.

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Ephedra FDA Ban Overview

Ephedra was one of the most popular dietary weight loss products on the market, used by millions of consumers to support fat loss and appetite suppression.

This product was also taken by athletes and bodybuilders for its ergogenic effects. It was commonly used in pre-workout formulas to boost energy, circulation and muscle tissue oxygenation.

The supplement was clinically studied by a number of organizations around the world and found to promote modest weight loss effects in conjunction with diet and exercise. It worked by boosting your metabolism, increasing heart rate and causing more body fat to be burned for heat generation.

Ephedra Sinica is a plant that grows around the world, but most prevalently in Asia and China. It is also referred to as “Ma Huang” and it derives its physiological effects from the presence of two primary alkaloids, ephedrine and pseudoephedrine.

There are other species of this plant found in the Southwestern United States, and in dry, arid climates around the Middle East and Mediterranean region, and along the western coastline of South America.

Ephedra has been cultivated and used for its medicinal properties for generations. Chinese cultures used the plant for thousands of years as a treatment for nasal congestion, asthma, colds, headaches, and symptoms associated with bronchitis and other lung conditions.

In the 1940’s, this herbal extract was introduced to the Western market. Medical practitioners and pharmaceutical developers isolated ephedrine as an effective component in drugs treating symptoms of asthma. This ingredient was also used to alleviate nasal congestion and open up bronchial passageways.

By the late 1970s and into the 1980s, ephedra and ephedrine products were listed as among the most popular to ever hit the dietary supplement marketplace for their purported ability to boost weight loss results and increase energy levels.

However, by the 1990s there were serious concerns about the risk of side effects from overuse of this ingredient. Even at standard therapeutic dosages, using ephedra diet pills was believed to increase the risk of heart attack, stroke and other serious adverse events.

There were also several high-profile cases of athletes testing positive for this substance. The media reported on some incidents of fatality wherein people who had used ephedrine diet aids were found dead from coronary complications. In many of these cases, the people involved had used excessively high dosages and combined this extract with other stimulant ingredients.

By 2004, the FDA had determined that “ephedra poses an unreasonable risk to those who use it.” After commissioning a study on the dangerous effects of this herb, they made the decision to ban all products containing ephedrine alkaloids.

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Dangers of Ephedrine Use

The ephedra plant family encompasses over 60 different species, some more potent than others. The plant contains alkaloids that trigger a stimulatory effect on the Central Nervous System.

The primary ephedra alkaloids that demonstrate bioactive effects include:

  • Ephedrine
  • Pseudoephedrine
  • Norephedrine
  • Norpseudoephedrine

By stimulating the nervous system, ephedrine in particular was shown to increase the rate at which the body burned calories. It also had an appetite controlling effect and caused individuals to feel less of a desire to eat or more satiated.

Finally, this supplement provided a burst of energy and motivation that many claimed could help to kick-start a diet or workout program. When used as directed, such products did help people achieve minor amounts of weight loss. Unfortunately, the product was often overused, misused, and abused.

U.S. Health Experts and the FDA Grow Concerned

During the early 1990s, complaints about side effects began reaching not only manufacturers of ephedra products, but government agencies and mediate outlets

Hundreds, and then thousands of complaints were logged with the U.S. Food and Drug Administration regarding serious adverse events among individuals using ephedrine-based products.

These agencies received increasing numbers of harmful reports of neurological, cardiovascular, and psychiatric effects. In addition to personal letters and notifications, articles began appearing in medical literature describing adverse events.

Not everyone who used this supplement experienced side effects and it would be an over-reaction to assume that this product is dangerous to all who took it. Many studies found that it could be well-tolerated if used at appropriate dosages in healthy individuals and under doctor supervision.

However, an analysis of these reports described a totally of 84 deaths, 26 heart attacks, 56 cerebrovascular accidents (stroke/hemorrhage), and dozens of other cardiovascular issues, reports of seizures, psychiatric events linked to ephedra use. [1]

Many counterarguments to these figured have been made, including suggestions that only 5 of the reported fatalities associated with ephedra use could actually be attributed to the effects of the product.

Supplement manufacturers argued that of the millions of people who took this product responsibly, adverse effects were minimal. However, concern for public health and safety resulted in a policy of banning these supplements.

As a result of the FDA ban on ephedra and ephedrine, a number of popular diet pills had to be re-formulated or pulled from the market. Some of the well-known brands included:

  • Metabolife
  • Ripped Fuel
  • Stacker 3
  • NaturalTRIM
  • Hydroxycut
  • Xenadrine RFA-1
  • Metabolift
  • Mini-Thins
  • Yellow Swarm
  • Yellow Jackets

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US Legal Status of Ephedra

Understanding the legal status of ephedrine and ephedra in the United States can be confusing because not all forms of this product are banned.

For example, many products containing ephedrine are still legal today. Products like Primatene, EPHED, and Bronkaid are all non-prescription drugs that are legally sold around the country for the treatment of asthma.

Over-the-counter dietary supplements that contain ephedra extract are also legal in the USA, despite the FDA ban. The ban specifically applies to the presence of ephedrine alkaloids in dietary supplements. Since not all species of ephedra contain these alkaloids, not all species are banned.

The legislation enacting the ban on ephedrine by reviewing the Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Small Entity Compliance Guide, which can be found on the website.

In the United States, supplements that contain ephedrine alkaloids are considered adulterated under section 402(f)(1)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342 (f) (1)(A)). [2]

This means that ephedrine alkaloids are banned in dietary supplements promoted for energy, fat loss or appetite suppression. However, ephedra extract (without the alkaloids) is not.

At the time of the ban, the majority of ephedra products contained the alkaloids, so manufacturers of had to remove their products from the shelves.

However, a number of manufacturers have since introduced variations of ephedra supplements that contain inert forms of the herb without any of the banned alkaloids. Typically, these supplements will contain legal alternatives to ephedrine like Synephrine which have similar effects but have not been banned by the FDA.

Note that different countries around the world have different laws on the ingredients allowed in dietary supplements. For example, in Canada, all ephedra and ephedrine products are banned from dietary supplements. However, use of ephedrine in bronchodilators and decongestant drugs is legal when restricted to 8 mg dosages. [3]

Are Ephedra Supplements Safe to Use?

The ephedra ban was put into place to protect consumers and to prevent the misuse and abuse of these diet pills.

Even natural, herbal products, when used incorrectly or in higher than recommended doses, can trigger serious side effects and adverse reactions.

While many disagree with the decision to ban ephedra by FDA as government overreach, the reports of the dangerous side effects in dozens of medical journals over the years suggest that these products were often used irresponsibly or taken by people with pre-existing medical conditions.

Ephedra contains Ephedrine, which is a pharmacologically active substance that has an influence over the central nervous system. It can interact with alpha and beta-adrenergic receptors, which are responsible for the mediation of sympathetic nervous system responses.

This substance increases sympathetic nervous system activity over functions like breathing, heart rate, energy metabolism, digestion and thermogenesis. As a stimulant, it may have some modest benefits for weight loss, but the positive effects often do not outweigh the negative effects.

While the majority of people are able to tolerate the effects of this drug at low doses, its use is contraindicated for individuals with certain pre-existing medical conditions and it can interfere with a number of other drugs and herbal products. Use of ephedrine or ephedra weight loss supplements can increase risk factors for a number of health conditions.

The same can be said for many other substances we commonly used today from alcohol to Aspirin to Tylenol to caffeine. However, the FDA determined that the risk was too high with ephedrine relative to the benefits for weight loss to allow this product to continue to be marketed.

The lack of dosage standards and the combination of this ingredient with other stimulants in dietary supplements necessitated regulation to prevent further harm.

This ban has not stopped consumers in the U.S., or other countries around the world, from purchasing their ephedra products and ephedrine from other countries.

However, quality control, mislabeled ingredients and the presence of adulterants in products sold by certain manufacturers remains of great concern to health experts around the world.

While the FDA’s ephedrine ban is here to stay, there are lots of other products that consumers can turn to for help with starting a weight loss diet that will not put your health at risk.

  Ephedra Fat Burners
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