There has been a constant battle between the FDA and dietary supplement brands. For decades, the FDA has been banned ingredients. Live Lean Today has compiled a list of the different banned substances, compounds, ingredients, and products. Each nutrients contain different reasons. The two most common are either safety or adulterated with non-labeled ingredients.
Live Lean Today offers a variety of products. Some may seem to be on the banned list though all products sold are 100% legal. For example, we are a certified retailer for ephedrine. The ephedrine sold is for temporary asthma relief. This is different than the ephedra alkaloids banned.
DMAA Diet Pills and Pre-Workout Supplements
Are you aware of the dangers lurking in some dietary supplements? The FDA has been working diligently to remove DMAA-containing products from the market to protect consumers like you. DMAA (1,3-dimethylamylamine) is a powerful stimulant that poses significant health risks, including high blood pressure, heart attacks, and even death. Learn what the FDA is doing to safeguard your wellbeing.
Since 2012, the FDA has employed a multi-faceted approach to eliminate these harmful products. This includes issuing warning letters to companies and conducting facility inspections to identify and discuss violations. When non-compliance persists, more stringent actions are taken. For instance, in 2013, the FDA detained OxyElite Pro and Jack3d, leading to their destruction and halting further production by USPLabs—products worth over $8 million at retail.
The FDA’s relentless efforts continued with Hi-Tech Pharmaceuticals. In 2017, a federal district court ruled that their DMAA-containing products were adulterated and ordered them for destruction. This decision was upheld by the U.S. Court of Appeals in 2019 and refused review by the Supreme Court in 2020. The products were finally destroyed on November 12, 2020.
The FDA remains vigilant in identifying and removing DMAA products from the market. Your safety is paramount—avoid purchasing or using any product containing DMAA.
Why Choose Safety First?
- Consumer Protection: The FDA’s stringent measures ensure only safe dietary supplements are available.
- Legal Compliance: Companies are held accountable for marketing unsafe products.
- Health Assurance: Avoid severe health risks associated with DMAA.
Stay informed and choose wisely. Trust in the FDA’s ongoing efforts to keep dietary supplements safe for consumption.
Banned DMAA Ingredients on Labels
1,3-DMAA | 1,3-Dimethylamylamine | 1,3-Dimethylpentylamine |
2-Amino-4-methylhexane | 2-Hexanamine, 4-methyl- (9CI) | 4-Methyl-2-hexanamine |
4-Methyl-2-hexylamine | Dimethylamylamine | Geranamine |
Methylhexanamine | Methylhexanenamine |
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Adulterated Ephedra Supplements
This essential guide, based on the final rule published by the FDA on February 11, 2004, and effective from April 12, 2004, is your definitive resource for understanding the legal landscape surrounding dietary supplements containing ephedrine alkaloids.
Key Features:
- Comprehensive Breakdown: This guide translates complex legal jargon into plain language, making it accessible for small business owners and stakeholders. Understand the regulation stated in 21 CFR 119.1 effortlessly.
- Legal Clarity: Discover why dietary supplements containing ephedrine alkaloids are deemed adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act. It’s illegal to market such products due to the unreasonable risk of illness or injury they pose.
- Scientific Foundation: Learn about the thorough scientific evaluation that informed this regulation. The guide covers pharmacological data, peer-reviewed literature, and adverse event reports that highlight the dangers of ephedrine alkaloids.
Benefits:
- Stay Compliant: Ensure your business adheres to FDA regulations by understanding and implementing the guidelines provided. Non-compliance can lead to severe legal consequences.
- Informed Decision-Making: Gain insights into the FDA’s current thinking and recommendations regarding dietary supplements containing ephedrine alkaloids. Make informed decisions that align with regulatory expectations.
- Protect Public Health: By following this guide, you contribute to public safety by avoiding the distribution of potentially harmful dietary supplements.
Whether you’re a small business owner, regulatory affairs professional, or health industry stakeholder, this compliance guide is indispensable for navigating FDA regulations with confidence. Equip yourself with knowledge and stay ahead in ensuring product safety and regulatory adherence.
Banned Ephedra Ingredients
Ephedra Alkaloids | Ma Huang | Ephedra Sinica |
Ephedra equisetina | Ephedra intermedia | Ephedra distachya L. |
Sida cordifolia L. | Chinese Ephedra | Epitonin |
Sea grape | Yellow horse | Joint fir |
Popotillo | Country mallow |
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DMBA or AMP Citrate Stimulants
Stay informed and safeguard your health with the latest updates from the FDA. On April 28, 2015, the FDA issued warning letters to 14 companies concerning 17 products labeled as containing DMBA, a new dietary ingredient. These warnings underline the FDA’s commitment to ensuring public safety and maintaining stringent standards for dietary supplements.
DMBA, deemed an adulterated substance by the FDA, has not met the necessary conditions to be included as a dietary ingredient. This recent action highlights the importance of regulatory compliance and consumer protection in the supplement industry. Under the Dietary Supplement Health and Education Act of 1994, the FDA possesses the authority to remove such products from the market, provided they establish that these products are either adulterated or misbranded.
The impacted companies have a 15-business-day window from receipt of the notice to outline their corrective measures to the FDA. Failure to comply may lead to further enforcement actions without prior warning. This proactive measure by the FDA is a stern reminder for manufacturers to adhere strictly to regulatory guidelines or face potential market removal.
By staying updated with these developments, you can make more informed choices about dietary supplements and ensure you are consuming safe, compliant products. The FDA continues to monitor and address any further issues related to DMBA, committing to ongoing updates and transparency.
This critical information serves as a reminder of why it’s essential to choose reputable brands that prioritize compliance and consumer safety. Stay vigilant, stay informed, and prioritize your wellbeing.
Banned DMBA and AMP Citrate Ingredients
1,3-Dimethylbutylamine | 2-Amino-4-Methylpentane Citrate | 4-Amino-2-Methylpentane Citrate |
AMP | Amperall | 4-Amino Methylpentane Citrate |
AMP Citrate | 4-AMP Citrate | 4-Methyl-2-Pentanamine |
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Banned Prohormone Products for Containing Steroids
Are you seeking optimal gains in your body-building journey? Beware! The FDA has released an alarming analysis showing that certain body-building products labeled to contain steroids and steroid-like substances are linked to serious liver injuries. These findings are crucial for every fitness enthusiast to consider before making a purchase.
FDA’s Findings and Alarming Statistics The FDA’s extensive review of adverse event reports has uncovered a disturbing trend: body-building products containing anabolic steroids (AAS) or their alternatives can lead to severe liver damage, often necessitating hospitalization. From July 1, 2009, to December 31, 2016, 35 cases of men aged 20-48 were reported with life-threatening liver injuries linked to these supplements. Elevated liver enzymes such as ALT, AST, and AlkP were common indicators of this damage.
Multiple Risks Beyond Liver Damage The dangers don’t stop at liver injury. Anabolic steroids are notorious for causing a myriad of other severe health issues including:
- Abnormal fat and cholesterol levels
- Mood disorders
- Androgenic effects like acne, baldness, and excessive hair growth in females
- Gonadal suppression leading to decreased sperm count and testicular atrophy
- Enlarged breasts in men
Uncertain Safety Due to Multiple Product Use Compounding the risk is the fact that many consumers use multiple body-building products simultaneously. This makes it difficult to pinpoint which specific product is responsible for the harmful effects, raising concerns about potential interactions between different substances.
Protect Your Health Your health is priceless. Be vigilant and informed about what you consume in your quest for fitness. Always consult healthcare professionals before starting any new supplement regimen, especially those that may contain anabolic steroids or their alternatives.
Banned Prohormone Products
5-Deca Zol, 19 Tren-Bol | Epi-Hardcore | Super D2 Hardcore |
Mass Xtreme | Novedex XT | Androbolin 350 |
Sterodol | Incredible Bulk | Tren 2 Xtreme |
Beastdrol | Serious Mass | Raptor |
Trimethyl Extreme | Super DMZ Rx | Muttant Plexx |
Tamox | Amino Max | A-HD |
Thunderbal | Anabol Cuts | M-Drol |
Alpha M60 | Epi-10 | 5-Deca Zol |
Mass Destruction | Mayhem | Mass Carnage |
Super DMZ 2.0 | Wolverine Xtreme | Beast Stack |
Halo suspension | Methyl Masterzine | PCT Revolution |
Methastadrol | Super DMZ | E-Shred |
Testplex 450 | Cellucor P6 | Methyl-Tren 550 |
Epi-10 | Epistane | Xtreme DMZ |
Super Tren-V | M-Sten Extreme | Penta Built |
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Adulterated Dietary Supplements
On May 9, 2022, the FDA issued a major update regarding the sale of adulterated dietary supplements, targeting multiple companies violating safety standards. This essential read, “FDA Sends Warning Letters to Multiple Companies for Illegally Selling Adulterated Dietary Supplements,” provides critical insights into these actions and their implications for consumers.
Key Updates:
- Date of Update: May 11, 2022
- Core Issue: The FDA has identified several companies selling dietary supplements containing unsafe food additives and new dietary ingredients (NDIs) without the necessary premarket notifications.
- Companies Involved: Advanced Nutritional Supplements, LLC; Exclusive Nutrition Products, LLC (Black Dragon Labs); Assault Labs; IronMag Labs; Killer Labz (Performax Labs Inc); Complete Nutrition LLC; Max Muscle; New York Nutrition Company (American Metabolix); Nutritional Sales and Customer Service LLC; Steel Supplements, Inc.
- Ingredients of Concern: Some products contain potentially harmful ingredients like 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine.
Banned Laxogenin Ingredients
5-laxogenin | 5a-Hydroxy-Laxogenin | (25R)-3beta,5alpha -Dihydroxyspirostan-6-one |
25-R-Spirostan-5A-Diol-6 -One-3-One | 25R Spirostan-5a-diol-6 -one-3-one Decanoate | 25R spirostan-5a-diol-6-one-3 -one undecanoate |
SARMS
Navigating the world of fitness and bodybuilding can be challenging, especially with the allure of quick fixes and shortcuts. The FDA has issued a stark warning about the use of Selective Androgen Receptor Modulators (SARMs) among teens and young adults. These chemical substances, often touted on social media as miracle solutions for muscle gain and enhanced athletic performance, are not FDA-approved and pose serious health risks.
SARMs mimic the effects of testosterone and anabolic steroids but come with a dangerous price tag. Despite being marketed as safe and effective by influencers and online sellers, SARMs are linked to severe health issues such as heart attacks, psychosis, liver injuries, infertility, and even testicular shrinkage. The lack of FDA approval means these products have not been tested for safety or efficacy, making their use extremely risky.
Parents and young adults must stay informed about the potential dangers of SARMs. These products are often sold under misleading labels like “dietary supplements” or “research use only,” creating a false sense of security. The FDA continues to receive adverse event reports related to SARMs use, although many cases go unreported due to a lack of awareness or reluctance to report side effects.
The FDA has taken stringent actions against companies selling these unapproved drugs and continues to educate the public on their harmful impacts. If you or someone you know is considering using SARMs, consult a healthcare professional first. Your health is too valuable to risk for temporary gains.
Banned SARMS
AC-262536 | ACP-105 | YK-11-OA |
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References
DMAA in Products Marketed as Dietary Supplements https://www.fda.gov/food/information-select-dietary-supplement-ingredients-and-other-substances/dmaa-products-marketed-dietary-supplements
Small Entity Compliance Guide: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-final-rule-declaring-dietary-supplements-containing-ephedrine
Recent FDA Action on Dietary Supplements Labeled as Containing DMBA https://www.fda.gov/food/cfsan-constituent-updates/recent-fda-action-dietary-supplements-labeled-containing-dmba
FDA analysis shows body-building products labeled to contain steroid and steroid-like substances continue to inflict serious liver injury https://www.fda.gov/drugs/drug-safety-and-availability/fda-analysis-shows-body-building-products-labeled-contain-steroid-and-steroid-substances-continue
FDA Sends Warning Letters to Multiple Companies for Illegally Selling Adulterated Dietary Supplements https://www.fda.gov/food/cfsan-constituent-updates/fda-sends-warning-letters-multiple-companies-illegally-selling-adulterated-dietary-supplements
FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults