Don’t take our word for it. Here’s every fact on this site, with its evidence grade, its caveats, and a link to the source, so you can check us.
We start you on the strong ones: findings that have been replicated or come from one large, well-controlled study. Moderate and weak facts are here too, labeled for what they are. Use “Link to this fact” to share a single card.
Laws and loopholes / Other evidence
UK SI 2026/109 adds a new maximum-use-concentration cap (0.001%-2%, by product type and age group) for hexyl salicylate, an ingredient already subject to the separate fragrance-allergen labeling threshold, not a new allergen added to the label-disclosure list.
Strong evidence.
Caveats
Read directly from the SI's Schedule 2 and Explanatory Note (2026-09-28). The concentration cap and the labeling-declaration threshold are two distinct legal mechanisms within the same Annex structure; conflating them would overstate what this SI does.
Source: UK SI 2026/109 Link to this fact
Laws and loopholes / Other evidence
Between the Spring 2025 and 2026 editions of the Unified Agenda, FDA's own self-projected date for its MoCRA fragrance-allergen labeling proposed rule slipped six months, from May 2026 to November 2026, and the rule's "Included in the Regulatory Plan" status changed from "Yes" to "No," with no CFR citation yet assigned in either edition.
Strong evidence: Government regulatory-tracking record comparing two editions of the same RIN; does not itself establish why the target slipped.
Source: Unified Agenda, RIN 0910-AI90, 2026 edition, accessed 2026-09-28 Link to this fact
Laws and loopholes / Other evidence
As of September 2026, more than two years after MoCRA's statutory June 29, 2024 deadline, FDA has not issued a proposed or final rule on cosmetic fragrance-allergen labeling.
Strong evidence: The Federal Register search result is a negative finding (absence of a document), not a citable published statement; phrased here as "as of September 2026" per the capture date.
Source: Unified Agenda, RIN 0910-AI90, 2026 edition, accessed 2026-09-28; federalregister.gov search, accessed 2026-09-28 Link to this fact
Laws and loopholes / Government agency
In 2023, the EU added mandatory individual labeling for 56 more fragrance allergens on cosmetic labels, on top of the 24 already required, bringing the total to roughly 80, not a jump to 56 total.
Strong evidence: Figure is the Commission's own recital arithmetic (24 + 56); several secondary sources mistakenly describe this as expanding the list 'to 56.'.
Source: Regulation (EU) 2023/1545 Link to this fact
Laws and loopholes / Government agency
The EU's 56 newly added fragrance allergens were identified by the Scientific Committee on Consumer Safety (SCCS) in a 2012 opinion (SCCS/1459/11), eleven years before the labeling requirement actually took effect.
Strong evidence: The regulation does not reproduce the SCCS opinion's own data tables; the gap between scientific identification (2012) and legal implementation (2023) is itself notable.
Source: Regulation (EU) 2023/1545 Link to this fact
Laws and loopholes / Government agency
The new EU fragrance-allergen entries are implemented as 45 new Annex III reference numbers (327-371), several of which bundle multiple named plant-oil species or chemical isomers under a single entry number — for example one entry covers 7 named rose species and another covers 4 named lavender/narcissus species.
Strong evidence: Counted directly from the regulation's Annex text, cross-checked against page-image crops of two entries.
Source: Regulation (EU) 2023/1545 Link to this fact
Laws and loopholes / Government agency
The EU's fragrance-allergen labeling thresholds are unchanged by the 2023 amendment: an individual allergen must be named when it exceeds 0.001% in leave-on cosmetic products or 0.01% in rinse-off products.
Strong evidence: Same thresholds as the original 2003 rule; the amendment only changes which substances they apply to.
Source: Regulation (EU) 2023/1545 Link to this fact
Laws and loopholes / Government agency
Cosmetics manufacturers had until 31 July 2026 to stop placing non-compliant fragranced products on the EU market, and retailers may continue selling existing non-compliant stock until 31 July 2028.
Strong evidence.
Caveats
Exact dates from the regulation's own footnotes (*1, *2, *4); for 17 updated entries, continued sale in the interim required already complying with the pre-2023 rules as of 15 August 2023.
Source: Regulation (EU) 2023/1545 Link to this fact
Laws and loopholes / Government agency
The EU's 2023 fragrance-allergen expansion includes many whole essential oils and plant extracts by species, not just synthetic single chemicals — including lavender, rose, bergamot, ylang ylang, clove, sandalwood, patchouli, cedarwood, geranium, and peppermint oils.
Strong evidence: Each named oil/extract is its own Annex III reference number with its own CAS number(s); 'natural' or 'essential oil' products are not exempt from these labeling obligations.
Source: Regulation (EU) 2023/1545 Link to this fact
Laws and loopholes / Government agency
New Zealand's cosmetics standard, as consolidated and current to 1 January 2026, has revoked the clause that let its EU-style named fragrance allergens be declared only generically as "fragrance" or "parfum": Schedule 1, condition 1(6) now reads "[Revoked]", with no replacement provision found anywhere in the 308-page text.
Strong evidence.
Caveats
Primary legal text, read and grepped in full for the override's operative language, which was not found restated anywhere. This is this ingest's own textual finding, not a labeling change EPA's own regulatory-history description of the amendment names.
Source: Cosmetic Products Group Standard 2020 (NZ, HSR002552, consolidated and current to 1 Jan 2026) Link to this fact
Laws and loopholes / Government agency
24 of the EU's original 26 classic fragrance allergens remain individually named in New Zealand's Schedule 5 at the same 0.001% (leave-on) / 0.01% (rinse-off) disclosure thresholds the EU uses; one of the missing two (Lilial, CAS 80-54-6) has been moved to Schedule 4 and banned outright rather than merely restricted.
Strong evidence.
Caveats
Verified by reading Schedule 5's table directly (refs 45, 69-92 still carry the threshold condition; ref 83, Lilial, now reads "Line moved or deleted" and appears instead at Schedule 4 entry #1666).
Source: Cosmetic Products Group Standard 2020 (NZ, HSR002552, consolidated and current to 1 Jan 2026) Link to this fact
Laws and loopholes / Government agency
New Zealand's 2026 amendment did not adopt the EU's 2023 expanded fragrance-allergen labeling list (Commission Regulation (EU) 2023/1545, ~56 additional substances); New Zealand's named-allergen disclosure regime remains pinned to the EU's pre-2023 list.
Strong evidence.
Caveats
Confirmed by an exact count: the Schedule 5 individual-disclosure-threshold condition appears exactly 24 times in the document, all within reference numbers 45-92; no entry beyond ref 92 (including methyl eugenol, ref 102, one of the EU's newly added substances) carries it.
Source: Cosmetic Products Group Standard 2020 (NZ, HSR002552, consolidated and current to 1 Jan 2026) Link to this fact
Laws and loopholes / Other evidence
The flavor industry's own trade association states that 'GRAS evaluations, by FEMA or FDA, do not require an assessment of potential inhalation toxicity' because the primary route is ingestion, and that no food safety body requires one, even though nearly all flavoring substances are volatile.
Strong evidence.
Caveats
Direct statement of the program's scope by its operators; it does not show that inhalation of these substances is harmful. Written by two FEMA employees and supported by FEMA (the flavor industry trade association); it is the industry's own account of its own program.
Source: Hallagan 2009, Food and Chemical Toxicology Industry-funded Link to this fact
Laws and loopholes / Other evidence
The FEMA authors state that use of a flavor ingredient in consumer products, tobacco, and other non-food items 'is therefore not covered by FEMA GRAS status', and that it is the specific use, not the substance, that is GRAS.
Strong evidence.
Caveats
Industry statement of the legal scope; it does not say how often flavor chemicals are used in non-food products. Written by two FEMA employees and supported by FEMA (the flavor industry trade association); it is the industry's own account of its own program.
Source: Hallagan 2009, Food and Chemical Toxicology Industry-funded Link to this fact
Laws and loopholes / Other evidence
Under US law a company may decide a substance is 'generally recognized as safe' and market it without telling FDA; the flavor industry's own authors call the lack of a legal requirement for FDA oversight of all GRAS determinations 'one of the primary, long-standing criticisms' and favor mandatory reporting.
Strong evidence.
Caveats
The same authors say FEMA has always informed FDA of its own flavor decisions (not independently verified here) and describe the flavor program as 'not a self-regulation program'. Written by two FEMA employees and supported by FEMA (the flavor industry trade association); it is the industry's own account of its own program.
Source: Hallagan 2009, Food and Chemical Toxicology Industry-funded Link to this fact
Laws and loopholes / Other evidence
Under a 1958 law exception, a food company can decide a chemical is 'generally recognized as safe' (GRAS) without telling FDA; since 1997 FDA's voluntary notice program reviews the company's own conclusion in a private exchange with no formal public comment, and virtually all new direct food chemicals now go this route instead of the formal food-additive petition.
Strong evidence.
Caveats
Describes the program's structure as characterized by the paper's Pew authors (an advocacy-side view); structure is documented in FDA's own rules and notices. Still true of the current final rule (2016); FDA proposed in August 2026 (91 FR 51834, not final) to make notice mandatory.
Source: Maffini 2013, Comprehensive Reviews in Food Science and Food Safety Link to this fact
Laws and loopholes / Other evidence
In October 2018 FDA removed seven synthetic flavorings (benzophenone, ethyl acrylate, methyl eugenol, beta-myrcene, pulegone, pyridine, styrene) from its food-additive list because they cause cancer in lab animals and the Delaney Clause required it 'as a matter of law', while stating the six still in use were safe at the amounts used in food.
Strong evidence.
Caveats
The delisting covers the synthetic forms; FDA states natural counterparts in foods are unaffected. The 'safe at use levels' conclusion is FDA's, reported here by an industry author.
Source: Hallagan 2020, Food and Chemical Toxicology Industry-funded Link to this fact
Laws and loopholes / Other evidence
The flavor trade association states that food GRAS status 'does not provide assurance that the flavor ingredients are safe for use in vaping products' and gives no authority to use them in such products.
Strong evidence: A direct statement by FEMA, printed in the paper; it concerns regulatory scope, not evidence of harm from any particular flavor.
Source: Hallagan 2020, Food and Chemical Toxicology Industry-funded Link to this fact
Laws and loopholes / Other evidence
The flavor industry's 1965 list of substances it called safe gives only the average of the maximum levels manufacturers reported using, in parts per million by food category, and its authors state these 'are not tolerances' and are guidelines to 'good manufacturing practice'.
Strong evidence: Stated by the authors; a later FEMA account describes more review than this paper shows.
Source: Hall & Oser 1965 (FEMA GRAS 3), Food Technology Industry-funded Link to this fact
Laws and loopholes / Government agency
US food law protects only the listed major allergens: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans at enactment (sesame was added in 2023). Other allergens inside a flavoring, color, or spice need FDA to write a separate regulation (403(x)), and the wiki found no such rule.
Strong evidence: The closed list is statute; the absence of a 403(x) rule rests on FDA's 2025 guidance as read in a sibling page, not on this document.
Source: FALCPA, Pub. L. 108-282 Title II (2004), Public Law 108-282, Title II, 118 Stat. 905 Link to this fact
Laws and loopholes / Government agency
A US food ingredient can be exempted from allergen labeling if its maker shows it has no allergenic protein: by petition (FDA must decide in 180 days or it is deemed denied) or by a notification that takes effect after 90 days unless FDA objects; highly refined oils are excluded from the definition outright (FD&C Act 201(qq)(2), 403(w)(6)-(7)).
Strong evidence: Statutory mechanism; how often it has been used is on FDA inventories not captured here.
Source: FALCPA, Pub. L. 108-282 Title II (2004), Public Law 108-282, Title II, 118 Stat. 905 Link to this fact
Laws and loopholes / Other evidence
In the EU, a flavoring can be sold as 'natural' only if its flavoring component consists exclusively of natural flavoring preparations and/or natural flavoring substances, and a label that names a source (for example 'natural strawberry flavoring') must have at least 95% by weight of the flavoring component come from that source.
Strong evidence.
Caveats
The rule governs the flavoring component only; carriers, solvents and additives may be present (Art. 3(4)). Check the consolidated text (current version dated 2026-02-16) for later amendments.
Source: EU Regulation 1334/2008, Art. 16(2) and 16(4) Link to this fact
Laws and loopholes / Other evidence
EU law defines a 'natural flavoring substance' as one that is 'naturally present and … identified in nature' and made by listed processes; processes that use singlet oxygen, ozone, metal or inorganic catalysts, organometallic reagents, or UV radiation do not count as 'appropriate physical processes'.
Strong evidence: Text of the law only; the capture does not show how Member States enforce it. The US definition (21 CFR 101.22(a)(3)) has no 'identified in nature' clause.
Source: EU Regulation 1334/2008, Art. 3(2)(c) and (k) Link to this fact
Laws and loopholes / Other evidence
The EU bans 15 substances from being added as such to food (agaric acid, aloin, capsaicin, coumarin, hypericine, beta-asarone, estragole, hydrocyanic acid, menthofuran, methyleugenol, pulegone, quassin, safrole, teucrin A, thujone) and sets food-by-food limits for them when they are naturally present in flavorings.
Strong evidence: Annex III numbers are from the original 2008 OJ text; the Regulation has been amended since, so check the consolidated version before quoting a limit as current.
Source: EU Regulation 1334/2008, Art. 6 and Annex III Link to this fact
Laws and loopholes / Other evidence
EU limits on estragole, methyleugenol, and safrole in food do not apply when the only flavoring in the food is added fresh, dried or frozen herbs, and spices.
Strong evidence: 2008 text; the derogation may have been revised.
Source: EU Regulation 1334/2008, Annex III Part B and footnote *1 Link to this fact
Laws and loopholes / Other evidence
In the EU, flavoring preparations made from food, thermal process flavorings made to the Annex V conditions, flavor precursors made from food and food ingredients with flavoring properties may be used without any evaluation or approval, unless the Commission, a Member State, or EFSA raises a safety doubt; only flavoring substances, preparations from non-food material and non-food source materials need the Union list.
Strong evidence.
Caveats
The exemption still requires compliance with Art. 4 (no safety risk on available scientific evidence; not misleading). The capture shows the legal route only, not how many products use it.
Source: EU Regulation 1334/2008, Art. 8(1) Link to this fact
Laws and loopholes / Government agency
EU food law requires 14 groups of allergens to be declared on labels: gluten cereals, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame, sulfites (above 10 mg/kg) and lupin and mollusks (Regulation 1169/2011, Annex II); the US list has nine.
Strong evidence: Text is the original 2011 version; later amendments to Annex II were not checked. US count is from FDA/FASTER Act pages in our evidence base.
Source: EU Reg 1169/2011 (OJ L 304) Link to this fact
Laws and loopholes / Government agency
In the EU the allergen duty applies to any ingredient or processing aid on the Annex II list "or derived from" it that is still present in the finished food "even if in an altered form" (Art. 9(1)(c)); Annex II names specific exemptions (for example fully refined soybean oil, wheat-based glucose syrups, lactitol) instead of a general protein test.
Strong evidence: Exemptions are conditional on the process not increasing allergenicity as assessed by EFSA (Annex II footnote 1). Text is the 2011 original.
Source: EU Reg 1169/2011 (OJ L 304) Link to this fact
Laws and loopholes / Government agency
Under Annex VII Part D of EU Regulation 1169/2011 a flavoring may be listed simply as "flavoring(s)" (or a more specific name); only quinine and caffeine used as flavorings must be named, immediately after the term "flavoring(s)".
Strong evidence.
Caveats
Original 2011 text; the definitions the term relies on are in Regulation 1334/2008. Compare US 21 CFR 101.22(h), which names a different set (protein hydrolysates, salt, MSG, onion/garlic/celery powders).
Source: EU Reg 1169/2011 (OJ L 304) Link to this fact
Laws and loopholes / Other evidence
GRAS status exempts a flavor from FDA premarket food-additive approval: the paper itself explains that the 1958 Food Additives Amendment 'explicitly' excludes GRAS substances from mandatory premarket approval, and the list is published by the industry panel, not by FDA.
Strong evidence: Legal description by the panel itself; says nothing on whether FDA later reviewed any entry.
Source: FEMA GRAS 25 (2011), Food Technology Industry-funded Link to this fact
Laws and loopholes / Government agency
FDA's 2016 final rule keeps notifying FDA about a food ingredient's 'generally recognized as safe' (GRAS) status voluntary: FDA wrote that it 'lack[s] express statutory authority to require companies to submit GRAS notices.'
Strong evidence.
Caveats
Response 28 (p. 54981-82) and Response 1. This is FDA's reading of its own authority; commenters disagreed, and FDA said mandating notice would need separate rulemaking. True of the 2016 final rule, which remains in force; on August 11, 2026 FDA proposed (not finalized) a mandatory notice rule, 91 FR 51834, comments due December 9, 2026.
Source: FDA 2016, 81 FR 54960 Link to this fact
Laws and loopholes / Government agency
Under US law a company can conclude on its own that a food ingredient is GRAS and sell it without telling FDA; FDA's 2016 rule calls this an 'independent conclusion of GRAS status that remains with the proponent' and says the same legal standard applies whether or not it is submitted.
Strong evidence.
Caveats
Response 128 and section I.E. FDA only 'strongly encourage[s]' contact and recommends, but does not require, that independent conclusions be organized like a notice and made public. FDA gives no estimate of how many conclusions are un-notified.
Source: FDA 2016, 81 FR 54960 Link to this fact
Laws and loopholes / Government agency
FDA's response to a GRAS notice is not an approval: the standard 'no questions' letter says the agency 'has not, however, made its own determination regarding the GRAS status of the subject use,' and the notifier remains responsible for safety.
Strong evidence: Table 1 (p. 54968) and Response 35. Describes the Interim Pilot program's letter text that the rule carried forward; letter wording may have changed since 2016.
Source: FDA 2016, 81 FR 54960 Link to this fact
Laws and loopholes / Government agency
FDA's 2016 rule says GRAS status through scientific procedures 'shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive,' based on generally available, ordinarily published data that unpublished data may only corroborate (21 CFR 170.30(b)).
Strong evidence.
Caveats
Quoted from the codified text. This is the legal standard; the Pew-group audits in this evidence base found many notified chemicals lacked published feeding studies, so the standard and practice may differ.
Source: FDA 2016, 81 FR 54960 Link to this fact
Laws and loopholes / Government agency
FDA must answer a filed GRAS notice within 180 days (extendable by 90), but a company may sell the substance without waiting for the letter; FDA says it may later decide the substance is an unapproved food additive and 'take action to remove the substance from the food supply.'
Strong evidence: 21 CFR 170.265(b)(1) and Response 35. Practical frequency of removal not given in the rule.
Source: FDA 2016, 81 FR 54960 Link to this fact
Laws and loopholes / Government agency
FDA names two cases where it acted after products reached the market on industry GRAS conclusions: partially hydrogenated oils (2015 determination that there is no consensus they are GRAS for any use in human food) and caffeine in alcoholic beverages (four 2010 warning letters), noting that for new uses without premarket engagement it 'must react to the new uses after they emerge.'
Strong evidence: Section I.D. FDA's own examples, not a count of all such cases.
Source: FDA 2016, 81 FR 54960 Link to this fact
Laws and loopholes / Other evidence
The FTC says homeopathic drugs get no special treatment in advertising: claims that a homeopathic product treats a condition must have a reasonable basis before they are made, and 'there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products.'
Strong evidence: Agency's own legal position, not a court ruling; applies to OTC products for self-limiting conditions amenable to self-diagnosis.
Source: FTC 2016 OTC homeopathic enforcement policy statement, Federal Register 81(239):90122-90123 Link to this fact
Laws and loopholes / Other evidence
Under the FTC's 2016 policy, a homeopathic ad for an unproven use is not necessarily deceptive if it clearly tells consumers there is no scientific evidence the product works and that its claims rest only on 1700s homeopathy theories not accepted by most modern medical experts.
Strong evidence: Enforcement policy, not a safe harbor: the FTC doubts many disclosures will work and will judge the ad's overall net impression.
Source: FTC 2016 OTC homeopathic enforcement policy statement, Federal Register 81(239):90122-90123 Link to this fact
Laws and loopholes / Other evidence
Under EU medicines law (Directive 2001/83/EC as amended by 2004/27), Member States must allow homeopathic products to be registered as medicinal products without proof of therapeutic efficacy, provided they are diluted enough to guarantee safety (at least 1 in 10,000 of the original stock).
Strong evidence.
Caveats
This is EASAC's description of the Directive, not the legal text; national schemes differ (simplified registration allows no stated indication, national rules schemes allow claims for minor conditions).
Source: EASAC 2017, EASAC Statement (September 2017) Link to this fact
Laws and loopholes / Other evidence
A homeopathic label does not exempt a drug from manufacturing rules: FDA treated the tablets as adulterated (CGMP violations, 21 CFR 210 and 211) and misbranded (label quantity of belladonna alkaloids did not match what FDA found).
Strong evidence: Primary legal text of the agency's own finding; it is the agency's position, and the letter does not report any court ruling.
Source: FDA requested recall letter, 7 Apr 2017, FDA letter (7 April 2017) Link to this fact
Laws and loopholes / Other evidence
FDA's position in 2017 was that homeopathic drugs are subject to the same requirements as other drugs and that nothing in the FD&C Act exempts them from adulteration, labeling, misbranding, or approval rules; marketing without approval is tolerated only under conditions in Compliance Policy Guide 400.400.
Strong evidence: This is the agency's stated legal reading in one letter; CPG 400.400 was later replaced by the 2022 guidance.
Source: FDA warning letter 521717, 7 Sep 2017, FDA warning letter (MARCS-CMS 521717), 7 September 2017 Link to this fact
Laws and loopholes / Other evidence
FDA states that homeopathic drugs are 'subject to the same regulatory requirements as other drugs' and that nothing in the FD&C Act exempts them from adulteration, labeling, misbranding, or approval requirements; they are marketed unapproved only under an enforcement policy (CPG 400.400).
Strong evidence: Agency statement of law and enforcement policy (the same position appears in FDA's 2022 guidance); it describes the legal rule, not how often it is enforced.
Source: FDA warning letter 17-NWJ-09, 20 Jun 2017 Link to this fact
Laws and loopholes / Other evidence
The RCVS statement tells UK vets that treatments they offer should be 'underpinned by a recognized evidence base or sound scientific principles' and that they 'should not make unproven claims about any treatments, including prophylactic treatments.'
Strong evidence: Professional conduct guidance for RCVS members; it binds vets, not product sellers, and the page does not say how it is enforced.
Source: RCVS 2017 complementary and alternative medicines position statement Link to this fact
Laws and loopholes / Government agency
According to the FDA's own 2019 draft guidance, no homeopathic drug product is approved by the FDA, and the law exempts them from none of the approval, adulteration, misbranding, or labeling requirements that apply to other drugs.
Strong evidence.
Caveats
Direct statement of agency position ("There are currently no homeopathic drug products that are approved by FDA"). It is a draft; the 2022 final guidance is the current policy. The statement is FDA's legal interpretation, not a court ruling.
Source: FDA draft guidance, Drug Products Labeled as Homeopathic (Oct 2019) Link to this fact
Laws and loopholes / Government agency
Homeopathic products can be sold over the counter because the 1938 federal drug law, sponsored by a senator who was himself a homeopathic practitioner, recognized the homeopathic pharmacopeia as a drug standard, and FDA has never reviewed these products for safety and effectiveness under its OTC drug review, deferring them in 1972.
Strong evidence: FDA's account of its own history (37 FR 9464, 1972). Deferral is not approval and not a finding of safety; FDA says every one is still an unapproved new drug.
Source: FDA draft guidance, Drug Products Labeled as Homeopathic (Oct 2019) Link to this fact
Laws and loopholes / Government agency
In its 2019 draft, FDA said that homeopathic products labeled and formulated to meet its old 1988 policy (CPG 400.400) had still caused or could have caused significant harm, which is why it proposed replacing the 1988 policy with risk-based enforcement priorities.
Strong evidence: FDA's stated rationale; whether the harm rate is high or low is not quantified in the document.
Source: FDA draft guidance, Drug Products Labeled as Homeopathic (Oct 2019) Link to this fact
Laws and loopholes / Other evidence
FDA states homeopathic drugs are held to the same rules as other drugs: 'nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.'
Strong evidence: Agency's statement of law; marketing without approval is nonetheless tolerated under CPG 400.400 enforcement policy.
Source: FDA warning letter to King Bio, 20 Mar 2019, FDA warning letter (20 March 2019) Link to this fact
Laws and loopholes / Other evidence
A 2021 federal law (the FASTER Act, Public Law 117-11) added sesame to the list of 'major food allergens' in the Federal Food, Drug, and Cosmetic Act, for food shipped in interstate commerce on or after January 1, 2023.
Strong evidence: Statute text only; says nothing about enforcement or how FDA applies it to flavors.
Source: U.S. Congress, Public Law 117-11 (FASTER Act), 135 Stat. 262 (2021), Public Law 117-11, 135 Stat. 262 Link to this fact
Laws and loopholes / Other evidence
The FASTER Act directed HHS to report to Congress within 18 months on a 'timely, transparent, and evidence-based' process for changing the major-allergen list, including what evidence of prevalence and severity should qualify an allergen.
Strong evidence: Statute requires the report and recommendations only; it does not itself create the process.
Source: U.S. Congress, Public Law 117-11 (FASTER Act), 135 Stat. 262 (2021), Public Law 117-11, 135 Stat. 262 Link to this fact
Laws and loopholes / Other evidence
In its March 2021 opinion, the EU's independent cosmetics safety committee (SCCS) concluded that benzophenone-3 (oxybenzone) at 6% is not safe as a UV filter in body-cream, propellant-spray, or pump-spray sunscreens, but is safe at 6% in face cream, hand cream, and lipstick.
Strong evidence: Scientific advisory opinion, not law; one regulator's committee, but it recomputes the whole dossier. Rests on rat NOAEL and modeled absorption, not on observed harm in people.
Source: SCCS 2021 (BP-3 opinion), SCCS final opinion (PDF) Link to this fact
Laws and loopholes / Other evidence
The SCCS judged benzophenone-3 safe as a sunscreen UV filter at up to 2.2% in body creams, propellant sprays, and pump sprays, or up to 1.7% if the same product also contains 0.5% BP-3 as a formula stabilizer; it also found 0.5% safe as a stabilizer in cosmetics generally.
Strong evidence: Advice to the European Commission; the legal limit is set separately in Annex VI of the Cosmetics Regulation and this document does not say it was changed.
Source: SCCS 2021 (BP-3 opinion), SCCS final opinion (PDF) Link to this fact
Laws and loopholes / Other evidence
According to FDA's December 2022 guidance, no homeopathic drug product has been approved by FDA, and none has been determined generally recognized as safe and effective; FDA says nothing in the law exempts homeopathic products from approval or labeling requirements.
Strong evidence: Agency's own legal position in a nonbinding guidance; not a court ruling. Describes unapproved status, not efficacy.
Source: FDA 2022 Homeopathic Drug Products guidance Link to this fact
Laws and loopholes / Other evidence
FDA's guidance says a homeopathic product that meets Homeopathic Pharmacopeia (HPUS) dilution standards can still be an enforcement priority, so HPUS listing is not a safe harbor.
Strong evidence: Wording of the guidance; applies to FDA enforcement, not to other countries.
Source: FDA 2022 Homeopathic Drug Products guidance Link to this fact
Laws and loopholes / Other evidence
Canada lets a food list same-class ingredients under a single class name, but only if each ingredient has more than one component and is not on the B.01.009(1) table, and the components are then listed right after the class name in descending order of collective weight (B.01.010(4)).
Strong evidence: The B.01.009(1) table is not in the capture, so which ingredients are barred from the class-name route is not shown here. Says nothing about flavor mixtures specifically.
Source: Canada FDR B.01.010 (Justice Laws, current to 2026-09-30), Canadian regulation Link to this fact
Laws and loopholes / Other evidence
FDA says no product labeled homeopathic is FDA-approved, and that homeopathic products sold in the US have not been reviewed by FDA for safety and effectiveness.
Strong evidence: Agency's own statement on approval status; says nothing about whether the products work. The legal basis is in the 2022 guidance.
Source: FDA consumer page: Homeopathic Products, FDA web page Link to this fact
Laws and loopholes / Other evidence
US food law requires allergen naming for only nine foods; FDA itself says over 160 foods have been reported to cause allergic reactions and their food source need not be named on labels, although FDA could extend the duty to spices and flavorings by regulation.
Strong evidence: Guidance does not report any such regulation being issued; the 'over 160' figure is FDA's statement, unreferenced in the document.
Source: FDA food allergen Q&A Ed. 5 (2025), FDA guidance for industry (Docket FDA-2022-D-0099) Link to this fact
Laws and loopholes / Other evidence
FDA's food allergen labeling law explicitly does not apply to cosmetics, drugs, or household cleaning products, so fragrance allergens in those products have no allergen-naming duty under it.
Strong evidence: Says nothing about the separate MoCRA fragrance-allergen rulemaking, which is still pending.
Source: FDA food allergen Q&A Ed. 5 (2025), FDA guidance for industry (Docket FDA-2022-D-0099) Link to this fact
Laws and loopholes / Other evidence
FDA sets no threshold for food allergens and does not require 'may contain' warnings; cross-contact is outside the allergen labeling duty, and advisory statements are voluntary and must only be truthful.
Strong evidence: Good manufacturing practice and preventive controls (21 CFR part 117) still apply to cross-contact.
Source: FDA food allergen Q&A Ed. 5 (2025), FDA guidance for industry (Docket FDA-2022-D-0099) Link to this fact
Laws and loopholes / Government agency
A US food label may list just "natural flavor", "artificial flavor" or "spice" (or a combination) instead of naming the flavor's constituents; 21 CFR 101.4(b)(1) exempts flavorings from the rule that ingredient names be specific rather than collective (21 CFR 101.22(h)(1)).
Strong evidence: Applies to foods under Part 101, not to cosmetics. Exceptions require naming protein hydrolysates, salt, MSG and ground vegetable tissues such as onion or garlic powder.
Source: 21 CFR 101 (4-1-24 ed.), Code of Federal Regulations, Title 21, Part 101 Link to this fact
Laws and loopholes / Government agency
Incidental additives that come into a food with a flavor or spice need not be declared if they are present at insignificant levels and have no technical or functional effect in the finished food (21 CFR 101.22(h)(2) with 101.100(a)(3)); processing aids removed before packaging also qualify.
Strong evidence: Whether a specific carrier or solvent in a given flavor qualifies depends on facts the regulation text does not supply; the text does not name carriers.
Source: 21 CFR 101 (4-1-24 ed.), Code of Federal Regulations, Title 21, Part 101 Link to this fact
Information, not medical advice. See also: myths we won’t tell you.