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 / Government agency
A flavor sold to a food manufacturer may be labeled with the single sentence "All flavor ingredients contained in this product are approved for use in a regulation of the Food and Drug Administration," but non-flavor ingredients and any flavor ingredient outside such a regulation must be listed separately (21 CFR 101.22(g)(2)).
Strong evidence.
Caveats
Governs supplier-to-manufacturer labeling, not the consumer ingredient list. The 1995 FEMA paper says FDA also treated FEMA GRAS lists as reliable for this purpose; the 2024 CFR text names only FDA regulations.
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
A sulfiting agent with no technical effect in a food is treated as insignificant, and exempt from ingredient declaration, only if no detectable amount is present; 10 ppm (mg/kg) or more of sulfite in the finished food is "detectable" (21 CFR 101.100(a)(4)).
Strong evidence: This is a labeling threshold, not a safety limit; methods are LC-MS/MS or AOAC 990.28.
Source: 21 CFR 101 (4-1-24 ed.), Code of Federal Regulations, Title 21, Part 101 Link to this fact
Laws and loopholes / Other evidence
The 2026 OEKO-TEX Standard 100 document contains no limit values: Annex 4 only points to an online limit table, so formaldehyde and dye limits by product class cannot be quoted from it.
Strong evidence: This describes the captured PDF only; the online table exists and was not captured. Figures quoted elsewhere (e.g. 75 mg/kg skin contact) are secondary.
Source: OEKO-TEX Standard 100 (2026) Industry-funded Link to this fact
Laws and loopholes / Other evidence
Canada's flavoring standard (CFIA Canadian Food Compositional Standards, Volume 9, section 9.1) does not define "natural flavor"; it defines "(Naming the flavor) Flavor" as a preparation "derived from the aromatic plant after which the flavor is named" (9.1.3), so it has no counterpart to the US 21 CFR 101.22(a)(3) or EU Reg. 1334/2008 Art. 3(2)(c) "natural" definitions.
Strong evidence: Only section 9.1 was captured; other CFIA guidance on labeling was not read.
Source: CFIA Canadian Food Compositional Standards Vol. 9 (page dated 2025-05-01) Link to this fact
Laws and loopholes / Other evidence
Canada lets a fruit extract, essence, or flavor be sold as "Naturally Fortified" when other natural extractives have been added, provided "51% of the flavoring strength" comes from the named fruit; the EU named-source rule is at least 95% by weight of the flavoring component (Art. 16(4)).
Strong evidence: "Flavoring strength" and weight by percent are different measures; the capture does not say how strength is measured, so 51% and 95% are not directly comparable.
Source: CFIA Canadian Food Compositional Standards Vol. 9 (page dated 2025-05-01) Link to this fact
Laws and loopholes / Other evidence
OEKO-TEX Standard 100 (Edition 02.2025) limits free and partially releasable formaldehyde to 75 mg/kg for textiles in direct skin contact (Class II), 150 mg/kg for no direct skin contact and 300 mg/kg for decoration fabrics; baby articles (Class I) must be 'not detectable', defined in the table as under 16 mg/kg.
Strong evidence: Edition 02.2025, not the current table; limits are lab-extraction values on tested components, not a safety finding; certifier is industry-run.
Source: OEKO-TEX Service GmbH, Standard 100 limit values Annexes 4-5, Ed. 02.2025 Industry-funded Link to this fact
Laws and loopholes / Other evidence
Canada's seasoning-mixture exemption is capped: a seasoning mixture (other than a spice or herb mixture) escapes component listing only if its total weight is no more than 2% of the weight of ingredients used (B.01.009(2) item 5).
Strong evidence: Spice or herb mixtures (item 4) carry no such percentage cap in the text.
Source: src-2026-canada-food-drug-regulations-b-01-009-to-b-01-010-4-allergens, Canadian regulation Link to this fact
Laws and loopholes / Other evidence
Canada's regulatory definition of 'food allergen' covers any protein, or modified protein including protein fractions, from 11 groups: nine named tree nuts, peanuts, sesame seeds, wheat or triticale, eggs, milk, soybeans, crustaceans, mollusks, fish, and mustard seeds (B.01.010.1(1)).
Strong evidence: The regulation does not use the phrase 'priority allergen'; celery and lupin are not in this text.
Source: src-2026-canada-food-drug-regulations-b-01-009-to-b-01-010-4-allergens, Canadian regulation Link to this fact
Laws and loopholes / Other evidence
Canada requires added sulfites at 10 parts per million or more to be shown on prepackaged food, in the list of ingredients or in the allergen 'Contains' statement, under names such as 'sulfites' or 'sulfiting agents' (B.01.010.2(3), (6)).
Strong evidence: Applies to added sulfites only (B.01.010.2(2)).
Source: src-2026-canada-food-drug-regulations-b-01-009-to-b-01-010-4-allergens, Canadian regulation Link to this fact
Laws and loopholes / Other evidence
Canada's allergen duty does not apply to allergen or gluten present 'as a result of cross-contamination' (B.01.010.1(3)); 'may contain' declarations are allowed but only their placement and typography are regulated (B.01.010.4), and nothing requires one.
Strong evidence: Whether CFIA expects precautionary labeling in practice was not read.
Source: src-2026-canada-food-drug-regulations-b-01-009-to-b-01-010-4-allergens, Canadian regulation Link to this fact
Laws and loopholes / Other evidence
Canada's 'Contains' statement must be introduced by 'Contains' (English) or 'Contient' (French) in bold, placed immediately after the ingredient list, and lists every allergen source, gluten source, and sulfites, even if already named in the list (B.01.010.3(1)).
Strong evidence: Format rule only.
Source: src-2026-canada-food-drug-regulations-b-01-009-to-b-01-010-4-allergens, Canadian regulation Link to this fact
Laws and loopholes / Other evidence
Canada's food regulations no longer define "natural flavor" in their flavoring-preparations division: of the 25 sections printed under Division 10 (B.10.003-B.10.027), 24 are marked repealed by SOR/2024-244, and none of the repealed text is in force.
Strong evidence.
Caveats
This shows only that Division 10 holds no definition. Other Divisions, incorporated documents and CFIA guidance were not captured, so it does not show Canada has no natural-flavor rule anywhere.
Source: Canada FDR Division 10 (2026 consolidation), Canadian regulation Link to this fact
Laws and loopholes / Other evidence
Canada's artificial/imitation flavoring wording rule (B.10.008) covers advertisements as well as labels ("On any label of or in any advertisement for").
Strong evidence: The US recorded text (21 CFR 101.22(i)) ties the "artificial" wording to the food name and label; comparison is limited to our summary of that section.
Source: Canada FDR Division 10 (2026 consolidation), Canadian regulation Link to this fact
Laws and loopholes / Other evidence
OEKO-TEX's own change notice says new limit values become binding for all its certifications (STANDARD 100, LEATHER STANDARD, ORGANIC COTTON, ECO PASSPORT) on 1 June 2026, after a three-month transition period.
Strong evidence: OEKO-TEX is an industry-run voluntary scheme; this is the scheme owner's own rule, not law, and no rationale or data is given for any change.
Source: OEKO-TEX Association, Limit values: New regulations 2026 (customer information, 03.03.2026) Industry-funded Link to this fact
Laws and loopholes / Other evidence
OEKO-TEX's 2026 notice creates a total-fluorine exception: if a product exceeds the total fluorine limit, no PFAS are found in targeted analyses and a verification test plus manufacturing documents show a non-PFAS source, the exceedance can be excused and a statement is added to the certificate. It was effective immediately.
Strong evidence.
Caveats
The total fluorine limit (100 mg/kg in Ed. 02.2025) and the PFAS limits are not changed; the notice defines PFAS as organics with at least one fully fluorinated carbon; applicant pays and submits its own documentation; industry-run scheme.
Source: OEKO-TEX Association, Limit values: New regulations 2026 (customer information, 03.03.2026) Industry-funded Link to this fact
Laws and loopholes / Other evidence
A US company can decide on its own that a food ingredient is 'generally recognized as safe' and sell it without FDA approval or even FDA's knowledge; the government's auditor (GAO, 2010) put it as: once a company concludes a substance is GRAS, it 'may market that substance as GRAS without informing FDA'.
Strong evidence.
Caveats
Describes the law as of February 2010; FDA's 2016 final rule kept notification voluntary, so the core point still holds today. FDA proposed in August 2026 (91 FR 51834, not final; comments due December 9, 2026) to make notice mandatory.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
From 1998 through 2008 only 274 GRAS notices (about 25 a year, from about 180 companies) were sent to FDA's voluntary program, and FDA told GAO it could not estimate how many GRAS determinations it was never told about.
Strong evidence.
Caveats
The number of un-notified determinations is unknown by FDA's own account; GAO gives one company's figure (about 5 a year) as an example only. Notices are not distinct substances (22 were resubmissions).
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
Of the 274 GRAS notices FDA received in 1998-2008, 77% got a 'no questions' letter, 6% were told the notice did not provide a basis for GRAS, and 15% were stopped at the company's request; even after a negative letter a company may market the substance.
Strong evidence: A 'no questions' letter is not an FDA finding that the substance is safe; the program does not affirm GRAS status.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
FDA said in 1997 it would conduct random audits of companies' GRAS data, but GAO found in 2010 that the agency had never done any; FDA also had not addressed documentation standards for companies that do not notify it.
Strong evidence: Applies to the period to 2009; the 2016 rule added documentation and 'generally available' data criteria for everyone claiming GRAS.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
In 2010 the 1997 proposed rule that governs FDA's GRAS notification program was still not final after 13 years; FDA had not responded to comments from over 30 organizations and said it had 'no specific schedule' to finalize it (the final rule came in August 2016).
Strong evidence: The 2016 date comes from our FDA rule page, not from GAO.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
FDA last systematically reconsidered GRAS substances in the 1970s and 1980s: an outside committee (FASEB) reviewed 422 substances and questioned the safety of 35, yet by December 2009 FDA had issued regulations affirming only 17 of them and had done nothing on the other 18.
Strong evidence: Questioned means evidence was lacking or did not show absence of harm at current intake; it is not a finding of harm. No GRAS status was revoked.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
Of 11 citizen petitions asking FDA to act on GRAS substances between 2004 and 2008 (including salt, trans fats, aluminum additives, MSG, carrageenan, and diacetyl), FDA had decided only one (a stevia petition, denied) as of December 2009, usually citing limited resources.
Strong evidence.
Caveats
Petition status is as of December 2009; the petitions' scientific claims were not assessed by GAO. Later decisions (e.g., FDA's 2015 action on partially hydrogenated oils) are outside the report.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
A company can market a food ingredient made with engineered nanomaterials as GRAS without telling FDA; GAO found FDA 'has no way of knowing the full extent' to which such materials have entered the US food supply, while Canada and the EU require premarket review of all such ingredients.
Strong evidence: Describes 2010; FDA later issued nanotechnology guidance (outside this report). Nanoscale versions of already-GRAS substances were not shown to be unsafe.
Source: GAO 2010, GAO-10-246 Link to this fact
Laws and loopholes / Other evidence
UK homeopathic products could be licensed without showing that they work: the MHRA's three schemes (Product Licenses of Right, the Simplified Scheme, the National Rules Scheme) did not require clinical-trial evidence of efficacy as for conventional medicines, and about 3,000 old licenses were still in force in 2010.
Strong evidence: Describes the UK regime as of early 2010; rules have since changed after the Government response and EU/UK reforms. The NRS still required a dossier on quality and safety.
Source: UK House of Commons Science and Technology Committee, Evidence Check 2: Homeopathy (HC 45), Feb 2010 Link to this fact
Laws and loopholes / Other evidence
MHRA guidance accepted 'homeopathic provings' as support for an application, though the homeopathic manufacturers' own chairman told the committee a proving 'is not a way of doing a trial'.
Strong evidence: MHRA's stated position was that this was not an endorsement of efficacy; the committee called the efficacy wording 'misconceived and confusing'.
Source: UK House of Commons Science and Technology Committee, Evidence Check 2: Homeopathy (HC 45), Feb 2010 Link to this fact
Laws and loopholes / Other evidence
In July 2010 the UK Government rejected a parliamentary committee's call to stop NHS funding of homeopathy, saying local NHS bodies and clinicians, not Whitehall, are best placed to decide, and that it would not remove Primary Care Trusts' flexibility.
Strong evidence: A statement of government position, not evidence about homeopathy; says it will 'keep the position under review'.
Source: UK Department of Health, Government Response to the Science and Technology Committee report 'Evidence Check 2: Homeopathy', Cm 7914 (July 2010), Command Paper Cm 7914 (July 2010) Link to this fact
Laws and loopholes / Other evidence
BSAVA states that regulation of a treatment exists to protect patient safety and does not by itself mean there is scientific evidence that it works.
Strong evidence: UK legal context; the page is the association's reading of regulation, not a legal text.
Source: BSAVA position statement on complementary and alternative therapies (reviewed 2024) Link to this fact
Laws and loopholes / Other evidence
EWG Verified is a voluntary certification run by an advocacy nonprofit; it is not a government standard and carries no legal authority.
Strong evidence: Straightforward from the program's description as a certification and licensing scheme.
Source: EWG Verified FAQ, verified-portal.ewg.org, accessed 2026-10-16, EWG Verified portal web page Link to this fact
Laws and loopholes / Other evidence
In March 2006 the EU's consumer-product scientific committee (SCCP) declined to endorse higher non-preservative levels of cetrimonium, steartrimonium and behentrimonium chloride in cosmetics, calling the industry's safety information inadequate and asking for skin-absorption, sensitization and genotoxicity studies.
Strong evidence: A 2006 opinion on one industry dossier; later superseded by a 2009 SCCS opinion and EU Regulation 866/2014, which allowed the same hair-product limits. It is not a finding of harm.
Source: SCCP 2006 Industry-funded Link to this fact
Laws and loopholes / Other evidence
In December 2009 the EU's consumer-safety scientific committee (SCCS) concluded that cetrimonium, steartrimonium and behentrimonium chloride pose no health risk in hair products and face creams at set maximums: rinse-off hair 2.5% (5.0% for behentrimonium), leave-on hair 1.0% (3.0%), and face cream 0.5% (3.0%).
Strong evidence: The committee's own text; it is advice, not law, and rests on industry-submitted data. The face-cream 0.5% limit applies to the sum of cetrimonium and steartrimonium chloride.
Source: SCCS 2009 trimoniums, SCCS opinion (PDF) Link to this fact
Laws and loopholes / Other evidence
The EU's 2014 limits for cetrimonium, steartrimonium and behentrimonium chloride in hair products and face products match the numbers in the scientific committee's 2009 opinion, which the 2014 regulation cites as its basis.
Strong evidence: The regulation extends the facial-cream limit to all leave-on face products and states sums for combined use; the link is the regulation's own citation of the opinion.
Source: SCCS 2009 trimoniums, SCCS opinion (PDF) Link to this fact
Laws and loopholes / Other evidence
In 2010 the EU's cosmetics safety committee (SCCS) ruled that sodium perborate, a hydrogen peroxide-releasing bleach in powder hair dyes, counts as a hydrogen peroxide releaser under the EU cosmetics hydrogen peroxide entry, so the hydrogen peroxide limits (12% for hair care) apply to it.
Strong evidence: Committee advice, not itself a legal limit; the opinion does not convert the 3% perborate into a hydrogen peroxide percentage.
Source: SCCS 2010 (SCCS/1345/10), SCCS opinion SCCS/1345/10 (PDF) Link to this fact
Laws and loopholes / Review of other studies
Under US law a company may decide on its own that a food chemical is 'generally recognized as safe' and put it in food with no legal duty to tell FDA; the Pew authors say the decision can rest on the company's own employees or an expert panel it selects.
Strong evidence: Legal description by Pew Health Group authors (advocates of mandatory notice); FDA's 2016 rule confirms notice stays voluntary. Dated 2011.
Source: Neltner et al. 2011, Compr Rev Food Sci Food Saf, Comprehensive Reviews in Food Science and Food Safety Link to this fact
Laws and loopholes / Government agency
Since 29 August 2014 the EU has capped cetrimonium chloride and steartrimonium chloride at 2.5% in rinse-off hair products, 1.0% in leave-on hair products and 0.5% in leave-on face products, and behentrimonium chloride at 5.0%, 3.0% and 3.0% in the same product types (Annex III entries 265 and 266), with the combined amounts tied to those maximums.
Strong evidence.
Caveats
Numbers and product types confirmed against the Official Journal print (2026-10-23). Sum rule: each limit applies to the individual substance or the sum (entry 265: cetrimonium plus steartrimonium; entry 266: all three chlorides, while also respecting the entry 265 sum limit). Applies to non-preservative use only; as preservatives the cap is 0.1% (Annex V entry 44).
Source: Commission Regulation (EU) No 866/2014 Link to this fact
Laws and loopholes / Government agency
In the EU, the C12-22 trimethylammonium bromides and chlorides (including cetrimonium, steartrimonium, laurtrimonium and behentrimonium salts) are capped at 0.1% when used as preservatives, while the same chlorides are allowed at 0.5-5.0% for non-preservative uses in hair and face products.
Strong evidence: Annex V entry 44 prints no product-type restriction; the higher Annex III figures apply only to the three chlorides and only to hair and leave-on face products.
Source: Commission Regulation (EU) No 866/2014 Link to this fact
Laws and loopholes / Government agency
EU regulators extended the scientific committee's leave-on facial cream limits for these quaternary ammonium conditioners to all leave-on face products, reasoning there was no reason to limit them to face creams only.
Strong evidence: Regulatory reasoning in recital 5, not new safety data.
Source: Commission Regulation (EU) No 866/2014 Link to this fact
Laws and loopholes / Other evidence
In a proposed order issued September 24, 2021, the US Food and Drug Administration proposed that sunscreens containing oxybenzone (benzophenone-3) are not generally recognized as safe and effective (GRASE), because the evidence in the record is inadequate.
Strong evidence.
Caveats
This is a PROPOSED order. The document cannot show whether it was finalized, revised or withdrawn; status is as of its date (2021-09-24). FDA states this is not a conclusion that the ingredient is unsafe.
Source: FDA proposed order OTC000008 (2021) Link to this fact
Laws and loopholes / Other evidence
FDA's 2021 proposed order states that the 1999 sunscreen monograph text, including oxybenzone at up to 6 percent, is the Deemed Final Order under the CARES Act, so the stayed-Part status printed in the CFR is not the whole legal picture.
Strong evidence: This describes FDA's legal reading in a 2021 proposal, not a court ruling. Later changes are not known from this document.
Source: FDA proposed order OTC000008 (2021) Link to this fact
Laws and loopholes / Government agency
EU law caps benzophenone-3 (oxybenzone) as a UV filter at 2.2% in body products, including propellant and pump sprays, against 6% in face, hand and lip products (excluding sprays) and 0.5% in other products.
Strong evidence.
Caveats
Legal text, Annex VI entry 4 (Official Journal print checked 2026-10-23). The 2.2% body-product cap applies unless 0.5% benzophenone-3 is also used to protect the formulation; then the UV-filter level is capped at 1.7% (body) or 5.5% (face, hand, lip). Warning 'Contains Benzophenone-3' is required for categories a) and b), except at 0.5% or less used only for product protection.
Source: Commission Regulation (EU) 2022/1176, Annex VI entry 4 (OJ L 183, 8.7.2022) Link to this fact
Laws and loopholes / Government agency
EU law caps octocrylene as a UV filter at 9% in propellant spray products and at 10% in other products.
Strong evidence: Legal text, read from the EUR-Lex print (page 4); footnote (*3) requires benzophenone impurity or degradation product to be kept at trace level, with no numerical limit printed.
Source: Commission Regulation (EU) 2022/1176, Annex VI entry 10 (OJ L 183, 8.7.2022) Link to this fact
Laws and loopholes / Government agency
Cosmetic products that complied with the rules in force on 27 July 2022 could be placed on the EU market until 28 January 2023 and sold until 28 July 2023.
Strong evidence: Transitional periods as printed; these lapsed in 2023, so they are historical for current products.
Source: Commission Regulation (EU) 2022/1176, footnote (*1) Link to this fact
Laws and loopholes / Government agency
The Commission set the 2022 EU limits on the SCCS opinion: the SCCS found 6% benzophenone-3 not safe in body sunscreens, and the Regulation states a potential risk to human health at the previous concentrations.
Strong evidence: The Regulation's own account of the SCCS opinion (SCCS/1625/20); the SCCS opinion itself is in our evidence base as src-2021-sccs-opinion-benzophenone-3 and was not re-read here.
Source: Commission Regulation (EU) 2022/1176, recitals 3 and 8 Link to this fact
Laws and loopholes / Government agency
The EU did not ban benzophenone-3 or octocrylene in 2022; both stay legal at reduced maximum concentrations.
Strong evidence: Read from the entries and recitals. The Regulation does not call either substance an endocrine disruptor; it cites 'concerns related to potential endocrine disrupting properties'.
Source: Commission Regulation (EU) 2022/1176, recital 2 Link to this fact
Laws and loopholes / Other evidence
FDA's own drug-registration rule says that registering a facility, listing a drug, or getting a National Drug Code (NDC) number does not mean the drug is approved or may be legally sold; claiming otherwise counts as misbranding.
Strong evidence: Reads the 4-1-22 CFR edition; later amendments are not shown. Says nothing about whether any particular product is listed.
Source: 21 CFR 207 (2022 ed.) Link to this fact
Laws and loopholes / Other evidence
Nonprescription drugs sold without FDA approval still have to be listed with FDA, and the maker must file the product label, package insert and sample promotional labeling.
Strong evidence: Listing is not approval (see 207.77). Text is the April 1, 2022 CFR edition; later amendments are not shown.
Source: 21 CFR 207 (2022 ed.) Link to this fact
Laws and loopholes / Other evidence
FDA's drug registration and listing rule (21 CFR Part 207, 2022 edition) never mentions homeopathic drugs and has no homeopathy exemption, so whether it applies to a homeopathic product depends on the general legal definition of a drug.
Strong evidence: Describes what the 2022 text says, not how FDA applies it. FDA's 2017 warning letter and 2022 guidance state that homeopathic drugs face the same requirements; this rule does not.
Source: 21 CFR 207 (2022 ed.) Link to this fact
Laws and loopholes / Other evidence
The 2024 talc evaluation replaces IARC's earlier labels: perineal talc body powder was Group 2B (possibly carcinogenic) in 2006 and inhaled talc without asbestos was Group 3 (not classifiable).
Strong evidence: Classification history as printed by IARC.
Source: IARC Press Release 352 (2024) Link to this fact
Laws and loopholes / Other evidence
In August 2025 FDA warned a homeopathic seller that its Cineraria Maritima D2 eye drops, promoted on its website for cataracts, are an unapproved new drug that cannot lawfully be sold across state lines, and stated that nothing in the FD&C Act exempts homeopathic drugs from approval requirements.
Strong evidence: Warning letter states FDA's allegations at the time; the firm's response and outcome are not in the capture.
Source: FDA warning letter 708635 (25 Aug 2025), FDA warning letter (MARCS-CMS 708635), 25 August 2025 Link to this fact
Laws and loopholes / Government agency
In August 2026 FDA proposed a rule that would require anyone introducing a food or food-contact substance on a 'generally recognized as safe' (GRAS) conclusion to notify FDA of the basis; today notice is voluntary, and the proposal says that if finalized, GRAS notices 'will be required for the first time.'
Strong evidence: A proposed rule (91 FR 51834, Aug 11, 2026; comments due December 9, 2026), not law. The 2016 voluntary notice stays in force until a final rule; final text could differ.
Source: FDA 2026, 91 FR 51834 (proposed) Link to this fact
Laws and loopholes / Government agency
FDA proposes that a final mandatory-GRAS-notice rule take effect 60 days after it is published, with a compliance date of 18 months after that, and a one-year window for products already on the market to send a streamlined submission instead of a full notice.
Strong evidence.
Caveats
Proposed dates only, keyed to a final rule that does not yet exist; no calendar date is set. The streamlined option would not be allowed for a use that already drew an insufficient-basis letter.
Source: FDA 2026, 91 FR 51834 (proposed) Link to this fact
Laws and loopholes / Government agency
Under FDA's proposal, companies could still reach their own GRAS conclusions and sell the product; the change is that they would have to tell FDA the basis, and FDA says the proposal 'do[es] not establish a premarket review program.' Failing to notify would be one factor in FDA's priority list for post-market review, with no separate penalty described.
Strong evidence: Proposed text and FDA's explanation (Sec. V.F). Final enforcement wording could change; the preamble pages read describe no penalty beyond prioritization.
Source: FDA 2026, 91 FR 51834 (proposed) Link to this fact
Laws and loopholes / Government agency
FDA estimates the proposed mandatory GRAS notice would cost about $89.6 million in present value over 10 years at a 3 percent discount rate (range $34.9-$210.0 million; about $10.5 million a year annualized), with benefits described only qualitatively as more information about substances in human and animal food.
Strong evidence.
Caveats
FDA's preliminary estimate in 2024 dollars; proposal stage and subject to change; FDA also finds a significant impact on a substantial number of small entities (about $7,800 to $53,100 per small entity, read from Table 3).
Source: FDA 2026, 91 FR 51834 (proposed) Link to this fact
Laws and loopholes / Other evidence
CIR's 1997 limit of 0.25% for cetrimonium chloride, cetrimonium bromide and steartrimonium chloride in leave-on products does not appear in its 2012 conclusion, which instead relies on the wording 'formulated to be nonirritating'; the report gives no explanation for dropping the cap.
Strong evidence.
Caveats
CIR is a voluntary industry panel, not a regulator; the EU separately sets its own limits. CIR is financed by the Personal Care Products Council, the cosmetics industry trade association.
Source: Becker et al. 2012 (CIR), Int J Toxicol, International Journal of Toxicology Industry-funded Link to this fact
Laws and loopholes / Other evidence
US food law lets companies leave incidental additives off the ingredient list if they are present at insignificant levels and have no technical or functional effect in the finished food; this covers carry-over from another ingredient, some processing aids, and substances migrating from equipment or packaging.
Strong evidence: Legal text, not a safety finding; the section says nothing about allergens or health. Current as of the eCFR snapshot of 2026-10-15.
Source: 21 CFR 101.100 (eCFR, 2026-10-15) Link to this fact
Laws and loopholes / Other evidence
A sulfite with no technical effect in a US food is exempt from labeling only if none is detectable; 10 ppm (mg/kg) or more of sulfite in the finished food counts as detectable and must be labeled.
Strong evidence: A labeling and detection threshold, not a safety limit; sulfites added for a technical effect are covered by other provisions not read here.
Source: 21 CFR 101.100 (eCFR, 2026-10-15) Link to this fact
Laws and loopholes / Other evidence
US food rules allow a manufacturer to omit a harmless marker from the label to protect a trade secret, but only after FDA has been given full information and has found the marker harmless and granted the exemption.
Strong evidence: One narrow provision; says nothing about how often it is used or about fragrance or cosmetics.
Source: 21 CFR 101.100 (eCFR, 2026-10-15) Link to this fact
Laws and loopholes / Other evidence
In US food law the bulk-bin exemption does not remove the buyer's right to ingredient information: food received in bulk at retail must show the ingredients on the bulk container label or a sign with lettering at least one-fourth inch high.
Strong evidence: Applies to food received in bulk containers at retail; compliance in practice was not assessed.
Source: 21 CFR 101.100 (eCFR, 2026-10-15) Link to this fact
Laws and loopholes / Other evidence
A US food label may list just 'natural flavor', 'artificial flavor' or 'spice' in place of the individual flavoring ingredients (21 CFR 101.22(h)(1)).
Strong evidence: Regulation text; says what the label may do, not what any product contains.
Source: 21 CFR 101.22 (eCFR 2026), Code of Federal Regulations, Title 21, Section 101.22 (eCFR) Link to this fact
Laws and loopholes / Other evidence
US law defines 'artificial flavor' as any flavor-imparting substance not derived from the listed spice, plant, meat, fish, poultry, egg, dairy or fermentation sources (21 CFR 101.22(a)(1)).
Strong evidence: Source-based definition, not a statement about hazard.
Source: 21 CFR 101.22 (eCFR 2026), Code of Federal Regulations, Title 21, Section 101.22 (eCFR) Link to this fact
Laws and loopholes / Other evidence
Four things cannot be hidden under 'natural flavor': protein hydrolysates used for flavor must carry their specific name, and onion, garlic, and celery powder, salt and monosodium glutamate must be named too (21 CFR 101.22(h)(3)-(5), (h)(7)).
Strong evidence: Named exceptions only; every other flavor constituent may stay under the collective term.
Source: 21 CFR 101.22 (eCFR 2026), Code of Federal Regulations, Title 21, Section 101.22 (eCFR) Link to this fact
Information, not medical advice. See also: myths we won’t tell you.