Herbalife Nutrition Ltd. is a multi-level marketing (MLM) company that creates and supplies nutritional and dietary supplements worldwide. 

Mark R. Hughes launched the company in 1980, and it currently employs 8,900 workers globally. 

The company is based in L.A, California, with its corporate offices in the Cayman Islands.


On the other hand, FDA regulates human pharmaceuticals and biologics, tobacco products, animal drugs, consumer electronics that produce radiation and even cosmetics. 

However, not all of those items go through premarket approval, which involves an FDA examination of the product’s effectiveness and safety as well as agency authorization before it can be sold. 

In other circumstances, FDA enforcement actions are directed at goods already placed on the market.

So, the question arises does FDA Approve Herbalife?


The FDA has requested Herbalife to stop displaying a film that the agency alleges the misleading impression that its weight-loss shakes and other products have received FDA approval.

The agency does not regulate natural dietary supplements. 

Health-care facilities, labs, and manufacturers are not “approved.” 

The FDA does have the ability to inspect controlled facilities to ensure that they comply with applicable GMP rules.

Owners and workers of domestic and international food, medicine, and most device facilities must enrol with FDA. 

New Medications and Biologics are Approved by the FDA

Before businesses can advertise new medications or biologics in interstate commerce, they must be shown as effective and safe to get FDA’s approval. 

Therapeutic proteins, cellular therapies, vaccines, and blood products are examples of biologics that needs approval. 

Companies must also demonstrate that they are capable of producing the medicine under federal standards of quality.

Before certifying a product, FDA does not create or evaluate it. Instead, FDA specialists examine the outcomes of manufacturers’ lab, animal, and human clinical testing.


If the FDA approves an item, it indicates the FDA has judged that the product’s benefits exceed the known dangers for the specified use.

Compound Medications are not Approved by FDA

Compounding is a process in which a chemist or physician blends chemicals to generate prescriptions tailored to specific patients’ needs. 

These people can be sensitive to substances in FDA-approved medicines or cannot swallow an FDA-approved pill. 

Users should be warned, however, that the FDA does not approve compounded medications. 

This implies that the FDA does not analyze compounded medication applications for safety, efficacy, or purity.

Are Herbalife Products Safe?

Herbalife nutrition clubs have been scrutinized due to a long history of safety concerns, including probable liver damage, liver failure, and an elevated risk of hepatitis.

According to the Journal of Hepatology and the Archives of Toxicology, hospitals in Argentina, United States, Iceland, Spain, Switzerland and Israel reported incidences of liver damage in Herbalife users. 

Some of these incidents occurred in the early 2000s.

Although positive diagnostic tests were available in 2015, investigators felt confident associating Herbalife to these risks following thorough examinations of the individuals’ medical histories.

The FDA Approves Food Additives in People’s Food

As long as a food product has not been premarket-approved by FDA, it still has the right to authorize specific ingredients until they are utilized in food. 


Additives, such as compounds added to food on purpose and colour additives, are examples of these.

Firms that seek to introduce novel food additives to the market must provide FDA with evidence that the additions are safe.

Specialists from the FDA examine the results of the excellent company testing to ensure that the food additive is safe for its intended usage. 

An approved food additive should be used according to the manufacturer’s instructions, requirements, and limitations.

Frequently Asked Questions (FAQs)

Is Herbalife FDA approved?

No, Herbalife is not FDA approved. 

Is Herbalife Carcinogenic?

Any Herbalife Nutrition goods or services are not endorsed or promoted by the American Cancer Society. Most nutritional supplements, notably Herbalife Nutrition products, have not yet been proven to help treat or prevent cancer.

Do Herbalife products cause liver failure?

Acute liver harm has been documented in the past after consuming Herbalife products, with two people suffering severe clinical liver failure and needing liver transplantation.

What are the effects of Herbalife products?

Nevertheless, the safety and effectiveness of their items have been called into doubt, with research suggesting that Herbalife products may cause liver damage. Jaundice, Liver injury, nausea, pale stool, lethargy, abdominal discomfort and fatigue have been linked to Herbalife products.

Final Words

Herbalife has been in the marketplaces for decades now. Still, some obligations and concerns revolve around different Herbalife products. This article will help you understand this product, and then you can decide whether you wish to use it or not.

This article is written based on online information, we don’t promote or harm any company’s reputation.