Is PhenQ FDA Approved? (No and Here’s Why!)

January 9, 2024 |

Posted By

Max Health Living is a reader-supported site. Purchases made through links may earn a commission. Learn more.

For this article, I have researched some FDA-approved weight loss supplements and discussed if PhenQ is safe and why the FDA does not approve it.

Key Points:

  • PhenQ is not FDA-approved.
  • PhenQ is still safer than many FDA-approved diet pills.
  • Find out more about PhenQ from its official website.

There is no extent to the risks that unapproved products may pose to your health. Correspondingly, a 2019 study reported that between 2005 and 2015, 1000 individuals aged 25 years or younger suffered from health issues after taking slimming supplements.

Therefore, you should always inspect the ingredient list of the supplements and question their reputation before buying them. PhenQ, in this case, is a safer option because it has been in the market for 15 years and doesn’t pose any dangerous risks.

In this article, you will find out why PhenQ is safe and better than other supplements and why it does not have FDA approval.

So, keep reading to know the details.

Are Weight Loss Pills FDA Approved?

Not all weight loss pills are FDA-approved, but still, some prescription obesity treatments have secured regulatory approval.

There are two reasons why you can’t find an FDA-approved tag on all weight loss supplements.

One is that some of them are herbal pills, and their approval doesn’t fall within the scope of the FDA.

The other reason is that most weight loss pills are purchased as dietary supplements, and FDA does not carry out pre-market reviews or grant approvals for over-the-counter supplements.

However, they may be retracted in case there are reports of concerning side effects or risks to safety.

So, if you are wondering, ‘is Oxitrim FDA approved,’ then no, it is not since it is also an OTC supplement.

Regardless of that, most unapproved weight loss supplements are just as good. They are easily accessible and allow long-term use as compared to prescription pills.

Nonetheless, FDA-approved anorectics are more potent and more effective for treating morbid obesity but are only available upon prescription from a doctor.

The FDA has approved seven prescription drugs for weight loss, and these are commonly known by the brand names, Adipex-P/Lomaira, Contrave, Saxenda, Xenical, Qsymia, Wegovy, and Imcivree.

In addition to these, Plenity is also an FDA-approved non-surgical ingestible device used for weight management.

Most of these FDA-approved weight loss medications and devices are prescribed to support the necessary lifestyle changes that will induce weight loss.

Therefore, these are recommended to overweight or obese individuals with a BMI of 30 Kg/m2 or greater or those with a BMI of 27 Kg/m2 or greater but are also co-morbid with a metabolic disease such as diabetes or hypertension.

But these FDA-approved treatments also carry some risks of side effects, which in some cases are very severe. Here is a brief insight into what they are:

1. Adipex-P Or Lomaira Risks

Adipex-P/ Lomaira (Phentermine) was approved by the FDA in 1959. It is a schedule IV drug and shows the potential for misuse; hence it cannot be taken for long-term.

Nonetheless, it is effective in suppressing the appetite by stimulating the sympathetic nervous system.

However, according to, it may cause psychosis, sleeplessness, dry mouth, headache, cardiovascular side effects, chest pain, trembling, trouble breathing, etc.

2. Qsymia risks

The FDA approved Qsymia (phentermine and topiramate) in 2012. It is a sympathomimetic amine and promotes weight loss by increasing energy expenditure and reducing appetite by increasing the level of norepinephrine and serotonin in the brain.

Yet again, according to, it may cause changes in taste and smell, insomnia, constipation, mood changes, dizziness, bronchitis, UTIs, eye pain, muscle pain, spasms, etc.

Furthermore, in severe cases, it may affect vision and heart rate and cause weakness in the lower extremities.

3. Contrave Risks

Contrave (naltrexone HCI/bupropion HCI) reduces appetite and inhibits fat absorption, and the FDA approved it in 2014.

It is prescribed as a long-term treatment, but according to WebMD, some common side effects associated with this drug include gastrointestinal issues, sleep problems, profuse sweating, flushing, and changes in taste.

Some serious side effects include mental or mood changes like anxiety and memory loss, ringing in the ears, fainting, severe headache, changes in heartbeat, and chest pain.

There are also rare reports of the development of severe allergic reactions or seizures, and clinical trials have reported that some participants developed hepatitis or liver disease with it.

4. Saxenda Risks

Saxenda secured FDA approval in 2020. It works as an agonist of the glucagon-like peptide-1 (GLP-1) receptor (GLP-1 is a hormone in the small intestine that decreases gastric motility) to promote a feeling of fullness.

However, it may cause gastrointestinal side effects (diarrhea, nausea, constipation, etc.), UTIs, gastroesophageal reflux disease (GERD), insomnia, shortness of breath, dizziness, nervous system reactions (stiff muscles, irregular heartbeats, tremors, etc.), vision problems (blurred vision, eye pain, and swelling, etc.)

Patients receiving treatments have also reported some serious side effects like allergic reactions, gall stones, kidney failure, depression and suicidal thoughts, thyroid tumors, or cancer.

5. Xenical Risks

Xenical (orlistat) works by inhibiting fat absorption in the body, and it was approved by the FDA in 1999.

Although its lower dose (Alli- 60 mg) can be purchased over the counter, its higher doses (Xenical-120 mg) require the doctor’s prescription.

According to WebMD, some side effects of this drug include oily spotting, oily/fatty stools, frequent bowel movements and decreased control over them, and in some cases, kidney stones and allergic reactions.

Furthermore, the FDA has received 32 cases of liver injury and 6 cases of liver failure in patients being treated with this drug.

6. Wegovy Risks

Wegovy was approved by the FDA in 2021. It mimics the glucagon-like peptide-1 (GLP-1) hormone and helps to lower the appetite.

But some of its common side effects mentioned in Medical News Today include gastrointestinal upset, heartburn, dizziness, constipation, and GERD.

In severe cases, it may cause diabetic retinopathy (damage to blood vessels in the eyes), low blood sugar, fast heart rate, allergic reaction, suicidal thoughts, gall bladder problems, thyroid cancer, and pancreatitis.

7. Imcivree Risks

Imcivree (setmelanotide) was approved by the FDA in 2020. It is prescribed for long-term weight management in people who have obesity due to certain genetic conditions.

Some of its side effects listed on are dry mouth, muscle spasms, dizziness, sleep problems, nausea, hair loss, Suicidal thoughts, sexual dysfunction (abnormally long erections), diarrhea, and hyperpigmentation.

8. Plenity Risks

FDA approved Plenity (cellulose and citric acid) in 2019, and it absorbs water and causes a feeling of fullness and satiety to regulate food intake, but it is prescribed only as a short-term treatment.

Plus, according to, it may cause abdominal pain, irregular bowel movements, distended bowel, flatulence, gastroesophageal reflux disease (GERD), or vomiting.

Considering all these risks associated with FDA- approved weight loss medications, you might want to try an all-natural supplement like PhenQ first.

Another reason is that most of the FDA-approved treatments are a bit too expensive and come at a price range between $90-$400, whereas PhenQ comes at a retail price of $80 per month.

Moreover, there is a risk of infection and discomfort at the injection site for injectables such as Saxenda, Imcivree, and Wegovy.

Related Post: Side Effects of Plenity

So, in the next section, I have explained why PhenQ is not FDA-approved but still heaps better than its approved counterparts.

PhenQ is NOT FDA Approved – Here’s Why

Approval of natural and herbal supplements does not fall under the jurisdiction of the FDA, which is why PhenQ, an all-natural supplement, is out of its scope of evaluation and verification.

Nonetheless, PhenQ has been around since 2008 and has over 320,000+ satisfied customers worldwide.

PhenQ bottle tablet

Apart from that, it is manufactured in FDA-approved and GMP-registered facilities; hence, you don’t have to worry about potential contamination in their batches.

There are no case reports of adverse reactions, and neither are there any lawsuits against it.

I further investigated ‘who makes PhenQ’ because it can also speak volumes about the reputation and efficacy of a product and found that it has been manufactured by Wolfson brands limited, which has been a part of the beauty and wellness business for the past 18 years (since 2005).

One proof of the company’s good fame is that it was chosen as a finalist among 5300 nominations in the Great British Entrepreneur awards for the best scale-up business of the year 2022.

Is PhenQ Safe? (Considering it’s not FDA-approved)

Absolutely! PhenQ is formulated such that it can be purchased by the general population without posing any alarming risks.

The best part is that it is a vegan supplement, contains well-researched and patented ingredients, and is free of controlled or banned substances.

Plus, you can continue taking it for as long as it is required for you to achieve your desired weight.

But still, all of us are somewhat impatient, so if you ask me how long it takes to see results with PhenQ, then you may start seeing a difference within 2 weeks and will most probably achieve your weight loss goals within 3 to 4 months.

PhenQ CTMoreover, the manufacturers have wisely ruled out any risk of overdosing on their ingredients by keeping their concentrations within and below the recommended daily limits set forth by the USDA and FDA.

Apart from this, PhenQ is also suitable for people with diabetes unless the doctor suggests otherwise.

Besides, it may cause only minimal and mild side effects like nausea, diarrhea, bloating, or headaches, and they may clear up on their own after your body adjusts to the ingredients.


Important Disclaimer: The information contained on MAX HEALTH LIVING is intended for informational and educational purposes only. Any statements made on this website have not been evaluated by the FDA and any information or products discussed are not intended to diagnose, cure, treat, or prevent any disease or illness. Please consult a healthcare practitioner before making changes to your diet or taking supplements that may interfere with medications.

Who We Are

We are a team of fitness, health, and supplement experts, and content creators. Over the past 4 years, we have spent over 123,000 hours researching food supplements, meal shakes, weight loss, and healthy living. Our aim is to educate people about their effects, benefits, and how to achieve a maximum healthy lifestyle. Read more.