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The Banned Substances Control Group (BSCG) Dietary Supplement Ingredient Advisory List identifies ingredients that do not qualify as lawful dietary supplement ingredients under U.S. regulations, including the Dietary Supplement Health and Education Act (DSHEA). The U.S. FDA used to have their own advisory list, but that list has been adjusted to an informational list that highlights FDA actions and communications and lacks the clarity needed to make real decisions on ingredient compliance.
The substances identified here include:
The BSCG Advisory List is a publicly available resource identifying:
Many of the ingredients below are marketed under multiple chemical names, plant extract aliases, or alternative labeling strategies. The confusion around naming conventions can make it challenging for athletes, military service members, first responders, or others to make effective choices of supplement products based on label reviews alone.
Under DSHEA, a dietary supplement must contain one or more of the following:
It must not be:
An approved drug An investigational new drug A biologic A compound investigated as a drug prior to supplement marketingFull reference: Dietary Supplement Health and Education Act (DSHEA).
Below are major ingredient categories frequently associated with enforcement actions or regulatory violations in dietary supplements.
SARMs are investigational drug compounds developed to mimic anabolic steroid effects. None of them are approved as dietary supplement ingredients. While some have been subject to clinical studies, none have been approved as prescription drugs. At the high doses found in illegal supplements there are concerns about liver toxicity and connections to cancer. Groups like the U.S. Department of Defense Operations Supplement Safety (OPSS) and U.S. Anti-Doping Agency (USADA) have warning against SARMs.
Common SARMs found in supplements include:
SARMs are prohibited under the World Anti-Doping Agency (WADA) Prohibited List.
FDA Reference: FDA SARMs Warning
AMPK activators and PPAR-delta agonists have also grown in popularity as muscle building substances. Some of these are synthetic substances that don’t qualify as legal dietary supplements. These categories are also banned by WADA and other sport or military drug testing programs. Sometimes these substances are marketed and sold as SARMs although they are technically in different pharmacological categories.
GHRPs are synthetic peptides designed to stimulate growth hormone release. Similar substances are designed to promote the release of hGH including secretagogues.
Examples include:
The U.S. Food and Drug Administration (FDA) has issued warning letters to manufacturers selling some of these compounds as supplements.
FDA Warning Letter Example: United Pharmacy Warning Letter (2019)
Peptides are one of the hottest trends in wellness today, yet many of the substances are actually unapproved drugs that do not qualify as dietary supplements and are not supposed to be compounded according to compounding pharmacy laws 503A and 503B. Other research only chemicals have become popular as dietary supplements or products made for subcutaneous injection. Such products are often sold with labels that state they are not for human consumption as that is the only legal way to sell unapproved drugs or chemicals that do not fit the DSHEA definition of a supplement or have yet to be approved as pharmaceutical drugs.
Examples include:
Synthetic stimulant compounds frequently appear in pre-workout and fat burner products. They are often marketed as plant extracts but are synthetic analogs. While some of these substances are prohibited in synthetic form, as a component in plants or botanicals they may be legal.
Examples include:
Aegeline – One of the early synthetic stimulants, this compound became infamous in OxyELITE Pro, which presented significant toxicity and adverse effects and received an FDA warning letter in 2013. A chemical rumored to come from the Bael Tree. The Bael tree is also known as Aegle marmelos, Arbre de Bael, Bael tree, Bel, Bel Indien, Bengal Quince, Bilva, Bilwa, Cognassier du Bengale, Coing du Bengale, Indian Bael, Manzana de Piedra, Membrillo de Bengala, Pomme du Bengale, Shivaphala, Stone Apple.
BMPEA – Acacia rigidula extract was rumored to be the natural source of this compound, but acacia can be toxic and was not considered a legitimate source. Other names for acacia rigidula are listed below. FDA BMPEA warning.
DEPEA – Dendrobium nobile, an orchid, was rumored to be a source of this ingredient, which became infamous in the Craze dietary supplement–which also contained DMPEA. The FDA issued a warning letter in 2014.
DMAA – One of the original synthetic stimulants. Geranium oil extract was often claimed to be the natural source of DMAA in an attempt to legitimize the ingredient. It quickly grew to include a variety of names and synonyms as outlined below. This ingredient became infamous in the Jack3D supplement. It should be noted that geranium and geranium oil are legitimate ingredients, while DMAA is not. The FDA began issuing warning letters in 2012.
DMBA – The legitimate source of this compound was suggested to be Pouchong tea extract but recent science has suggested it is not present in the tea. This compound grew to include many names on supplement labels with Amperall and AMP Citrate becoming popular names. The FDA has been issuing warnings since 2015.
DMHA – Compound is reportedly present in Kigelia Africana fruit extract, which might make it legitimate if derived from the fruit. However, many Kigelia Africana fruit extracts on the market appear to derive from bark. Juglans regia is the English walnut tree. This compound is reportedly present in the bark, which was not in the food supply prior to 1994, so it is not considered a legitimate source. Juglans regia seeds, or walnuts, are legitimate ingredients and are not reported to contain this compound. The FDA has issued a number of warning letters on DMHA
DMPEA – Eria jarensis extract is suggested to be a natural source of this compound and extracts still commonly occur in commerce as dietary supplements. Acacia species also may contain this compound but due to potential toxicity of acacia extracts these are usually not considered legitimate sources. It was included in the Craze supplement as a component of dendrobium extract.
Higenamine – The synthetic chemical higenamine does not appear to be a legitimate ingredient. Natural extracts that contain higenamine may be legitimate; this should be considered further as many plants may contain this compound. Annona squamosa, an African fruit, is one such interesting source to consider. Higenamine has been the subject of FDA enforcement action
Hordenine – The synthetic chemical hordenine is not a legitimate ingredient. However, hordenine is naturally present in cactus species, barley and other plants. Natural extracts of plants that contain hordenine may be legitimate, so this should be considered further. Hordenine has also been the subject of FDA enforcement actions and warning letters.
Isopropyloctopamine – The synthetic chemical isopropyloctopamine does not appear to be a legitimate ingredient, the FDA denied a NDI application in 2004. It is described as being several times more powerful than synephrine and other amines like octopamine that can be naturally found in citrus extracts. Synephrine and octopamine may be present in small amounts in legitimate citrus extracts such as citrus aurantium or sinensis. However, these substances are prohibited in sport, and as a result athletes need to be careful with citrus extracts due to drug-testing concerns.
NMPEA – The synthetic chemical NMPEA does not appear to be a legitimate ingredient. That said, NMPEA is naturally present in humans and also present in foods apple, cabbage, and acacia species. It can be found at <10 ppm in many foodstuffs. The synthetic ingredient is not legitimate while low levels of natural presence are to be expected.
Orchilean – It is not clear what Orhilean is or whether it is present in Cymbidium goeringii extract as suggested. Orchilean may be similar to DEPEA. It was marketed as a replacement to DMAA. Cymbidium goeringii is a legitimate natural product used in essential oils.
Oxilofrine – The synthetic chemical oxilofrine does not appear to be a legitimate ingredient and is included in FDA warnings. The compound may be present in legitimate citrus extracts in relatively small amounts.
Phenethylamine HCl – Phenethylamine (PEA) is the parent of the phenethylamine class. The synthetic chemical PEA does not appear to be a legitimate ingredient. WADA and other sports leagues prohibit PEA and its derivatives. There are many derivatives, making this a complex regulation to consider. Phenethylamine itself may be naturally present in many legitimate supplement ingredients and extracts, including cactus, cocoa, blue-green algae (cyanobacteria), and more. The synthetic form often appears as an active ingredient in supplements, which is the primary concern.
Certain nootropics have been approved as pharmaceutical drugs in other countries and as a result in the U.S. they do not qualify as lawful supplement ingredients. Many of these compounds often appear in cognitive enhancement supplements despite regulatory risk.
DMAA is not considered a lawful dietary supplement ingredient and has been subject to a number of FDA warning letters.
No. SARMs are investigational new drugs that are not legal supplement ingredients according to DSHEA. All SARMs are prohibited in sport as well.
Phenibut is not approved as a dietary supplement ingredient and has been the subject of FDA warning letters.
Yes. Higenamine appears on the WADA Prohibited List and is banned in sport. The synthetic ingredient higenamine is not a legal dietary supplement, although it may appear naturally in a variety of plants including Nandina domestica, which is commonly used in throat lozenges in Japan.
Noopept was developed as a synthetic drug in Russia. As a synthetic drug substance it does not qualify as a legal dietary supplement.
If the compound is synthesized and not legitimately derived from a lawful botanical source, it may not qualify as a dietary supplement ingredient.
Regulatory interpretation may vary internationally.
The BSCG Advisory List reflects BSCG’s interpretation of U.S. dietary supplement regulations and is provided for informational purposes only. Stakeholders may submit feedback or suggest additions or removals with supporting justification.
CNN Coverage on Tianeptine Risks: CNN Article
NIH PMC Article on Phenibut: NIH PMC Study
International Nootropic Regulations Review: Nootropics Expert Review
Alzforum Commentary: Alzforum News
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