Go Keto Fda Approval: What's The Verdict?

The FDA does not approve dietary supplements before they are marketed, unlike prescription medication. However, it does publish a list of unapproved products that have been subject to health fraud-related violations. This includes products that claim to cure, mitigate, treat or prevent disease, or those that contain undeclared ingredients. In 2022, the FDA recalled a keto supplement that was found to contain gluten, despite being labelled gluten-free. This is an example of a supplement that was not approved by the FDA.

Keto supplements can contain hidden gluten

The ketogenic diet, or keto, is a low-carb, high-fat approach to eating that aims to induce ketosis in the body, a metabolic state where fat is burned for energy instead of carbohydrates. While the keto diet itself does not contain gluten, some packaged and processed keto-friendly products on the market may contain hidden gluten. These include keto bars, shakes, flavoured cheese, snacks, and supplements.

In 2022, the U.S. Food and Drug Administration (FDA) announced that certain keto supplements, labelled as gluten-free, were found to contain gluten. The FDA warned that these supplements could cause "life-threatening" reactions in people with gluten intolerance, including upset stomach, diarrhea, fatigue, skin reactions, and more. The issue prompted experts to call for more federal oversight of the supplement industry.

Gluten is a combination of proteins found in wheat, barley, and rye. For those with celiac disease or gluten intolerance, consuming gluten can cause damage to the small intestines and other serious health issues. While the exact number of people affected by celiac disease is unknown, it is estimated to affect less than 1% of the population. However, many more are believed to have gluten sensitivity, which can be difficult to diagnose as there is no blood test available.

To ensure a gluten-free keto diet, it is important to carefully read product labels and opt for certified gluten-free options. Preparing meals from scratch using whole, unprocessed ingredients can also help to minimise the risk of gluten contamination. Some sauces and condiments, such as soy sauce and salad dressings, may also contain gluten, so it is important to check these products as well.

In summary, while the keto diet is naturally gluten-free, the presence of hidden gluten in some keto supplements and processed foods means that those with gluten intolerance or celiac disease must be vigilant about checking product labels and choosing certified gluten-free options to avoid potentially severe reactions.

The FDA does not approve supplements before sale

The FDA does not approve supplements before they are sold. While the Food and Drug Administration (FDA) defines dietary supplements and regulates their labelling and other safety practices, it does not approve them for safety and effectiveness or their labelling before they are sold.

The FDA does not approve dietary supplements for any purpose. The onus is on supplement companies to ensure their products are safe and accurately labelled. If a supplement claims to cure or fix a health problem, it is likely too good to be true.

Supplements are not subject to the same rigorous standards as prescription medication. The FDA does not approve supplement pills before sale, as it would with prescription medication. Instead, the FDA's role often begins after products enter the marketplace. Companies can produce and sell supplements without notifying the FDA, and the FDA works to ensure they meet safety standards and are accurately labelled.

The FDA can act when safety issues arise. If a product is found to be unsafe, the FDA can work with the company to bring the product into compliance or remove it from the market. The FDA can inspect manufacturing facilities and enforce the removal of health claims that only drugs can make.

The FDA does not approve the facilities that produce supplements, but it does have the authority to inspect regulated facilities to ensure they comply with current good manufacturing practices.

The FDA is calling for more oversight of the supplement industry

The FDA has taken steps to strengthen its oversight of dietary supplements, including the creation of the Dietary Supplement Ingredient Advisory List in 2019, which lists potentially unlawful chemical compounds. The FDA is also working on a new rapid-response tool to alert the public about unsafe ingredients in supplements.

The COVID-19 pandemic has exacerbated the problem, with sales of supplements skyrocketing and many businesses illegally marketing their products as treatments or cures for the virus. The FDA and the Federal Trade Commission sent 106 joint warning letters to supplement producers for selling products with fraudulent claims in the first six months of the pandemic.

Bipartisan legislation, the Dietary Supplement Listing Act, was introduced in 2022 to establish a mandatory product listing for supplements, requiring manufacturers to disclose detailed information to the FDA. While the legislation did not pass, it provides a blueprint for future policy.

The FDA is committed to new priorities when it comes to oversight of dietary supplements, including communicating concerns about unsafe ingredients quickly and ensuring a flexible regulatory framework. The FDA also emphasizes the importance of collaboration with industry partners and engaging in a public dialogue to get feedback from stakeholders.

The call for increased oversight aims to balance consumer access to lawful supplements while protecting the public from unsafe and unlawful products.

The FDA classifies some keto supplements as hazardous

The FDA does not approve dietary supplement pills before they are sold, unlike prescription medication. This means that the onus is on the consumer to be cautious when purchasing supplements.

In 2019, former FDA commissioner Scott Gottlieb overhauled the agency's supplement regulation, stating:

> "The growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers."

Despite this, the FDA's ability to enforce these regulations is limited. For example, in 2013, the FDA inspected only 416 supplement manufacturers for Current Good Manufacturing Practice (cGMP) adherence, representing just 10% of the estimated 4,000 manufacturers covered by cGMP regulations.

In addition, the FDA does not have the authority to prevent the sale of supplements containing new ingredients, even if they are deemed unsafe, until the courts rule in the FDA's favour. This means that companies can continue to sell supplements with dangerous ingredients for extended periods before facing consequences.

Furthermore, the FDA relies on voluntary reporting of adverse events (AEs) by consumers, which often results in underreporting. A 2009 Government Accountability Office report revealed that the FDA received only 596 serious and 352 mild or moderate AE reports over a 10-month period, while the estimated number of AEs occurring annually in the US is closer to 50,000.

The lack of stringent FDA regulation in the dietary supplement industry puts consumers at risk of serious adverse health consequences.

The FDA has recalled some keto supplements

The U.S. Food and Drug Administration (FDA) has recalled some keto supplements due to the presence of gluten, which poses a potential health risk to consumers. Natural Organics, Inc., voluntarily recalled four lots of its NaturesPlus Keto Living Sugar Control capsules, which were found to contain gluten during routine testing. This discovery prompted a nationwide recall to protect consumers from the risk of serious allergic reactions.

The affected products, Keto Living Sugar Control Capsules, were sold in 90-count bottles with white jars, black caps, and labels featuring orange, white, and black print. The product codes, lot numbers, and "Best By" dates were printed on the bottom of the bottle. The specific lots subject to recall are Natures Plus Keto Living Sugar Control Capsules with the following product details:

• Product No. 82004, UPC Code 097467820043, Lots 1362073 and 1365200, Best By 10/2025
• Product No. Ue82004, UPC Code 097467820043, Lots 1361754 and 1364325, BBE 10/2025

The FDA emphasized the health risks associated with consuming these supplements for individuals with gluten intolerance or wheat allergies. Reactions can range from minor to severe, including upset stomach, diarrhea, fatigue, skin reactions, and potentially life-threatening allergic responses.

Natural Organics, Inc., has taken proactive steps to address this issue by removing all affected products from inventory and initiating recall notices to accounts and consumers. They advise consumers who have purchased the recalled lots to return them to the place of purchase. This incident underscores the importance of proper labelling and the need for increased oversight in the supplement industry to ensure consumer safety.

Frequently asked questions