Australia New Zealand Food Standards Code – Standard 2.9.4 – Formulated supplementary sports foods

The central concept is “formulated supplementary sports food”. This is defined in section 2.9.4-2 as “a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals.” The definition is broad but is immediately constrained by the compositional and labelling rules that follow. Notably, the definition uses “sports people” not “athletes”, so it catches recreational users as well.

“One-day quantity” is defined as “the amount of that food which is to be consumed in one day in accordance with directions specified in the label.” This is the reference unit for the sodium and potassium limits (section 2.9.4-3(2)) and for claiming vitamin and mineral content. It means the manufacturer can control the compliance point by choosing the serving size and daily intake recommendation, but that choice must be reasonably based. If a product’s directions suggest unrealistic consumption, a regulator could argue the product is non-compliant because the one-day quantity would exceed the allowed limits.

The Standard then creates three subcategories in Division 3, each with its own definition:

• High carbohydrate supplement: at least 90% of average energy content from carbohydrate and more than 15% carbohydrate by weight when prepared (section 2.9.4-8(3)).
• Protein energy supplement: between 15% and 30% energy from protein, not more than 25% from fat, and not more than 70% from carbohydrate (section 2.9.4-9(3)).
• Energy supplement: not more than 20% energy from protein, with no explicit minimum carbohydrate or fat (section 2.9.4-10(3)). Note that energy supplement may be high fat: if more than 30% of energy comes from fat, an extra label statement is needed about special fat loading strategies.

A product that does not meet any of these three definitions is still a formulated supplementary sports food but cannot make the performance-related claims permitted in Division 3. That creates a regulatory asymmetry: a product with, say, 35% protein energy is still a formulated supplementary sports food, but it cannot claim muscle development or exercise usefulness. The practical incentive is to formulate products to fit one of the three definitions to access marketing allowances.

Another key concept is the cross-reference to other parts of the Code for permitted nutritive substances. Section 2.9.4-3(1) allows a vitamin or mineral only if listed in the table to S29-16, added in a permitted form from S17 or S29-17, and not exceeding the amount in S29-16 column 2. Similar tables exist for amino acids (S29-18) and other substances (S29-19). This means the Standard does not stand alone; compliance requires consulting multiple other standards and schedules.

Average energy content is calculated using the equation in S11-2 (note to section 2.9.4-2). That equation uses Atwater factors. The Standard does not provide alternative calculation methods, so manufacturers must use the prescribed formula to determine whether a product meets the subcategory thresholds.

The primary regulated entities are manufacturers, packers, importers and retailers of sports foods sold in Australia and New Zealand. This includes large multinational supplement companies, small local producers, online sellers, and anyone who places a product on the market that could be caught by the definition of “formulated supplementary sports food”. The definition is broad and captures any product “specifically formulated to assist sports people”, so a protein powder sold in a gym could be covered even if not labelled as a sports food. The key is whether the product is marketed to or intended for sports people for nutritional or performance goals.

Consumers are directly affected by the mandatory warnings and nutrition information. The warning “Not suitable for children under 15 years of age or pregnant women: Should only be used under medical or dietetic supervision” may deter purchase by parents or pregnant women, but it also potentially protects vulnerable populations from unsupervised use. The warning adds no direct cost to the consumer but may reduce consumption by those groups, which is the intended effect.

In New Zealand, the Standard is adopted under the Food Act 2014 (NZ) as noted in the text. New Zealand businesses face identical requirements, and the trans-Tasman mutual recognition scheme means a product compliant in one jurisdiction should be acceptable in the other, provided the Standard itself is uniform. However, enforcement is carried out by different agencies (state food authorities in Australia, Ministry for Primary Industries in New Zealand), so compliance risk varies by enforcement culture and resources.

Sports people themselves are affected by the limitation on claims. Because the Standard prohibits unapproved performance-related representations, consumers may have less information about a product’s actual ergogenic effects than they would under a more permissive regime. That may protect against overblown marketing, but it also suppresses truthful claims, reducing consumer choice and potentially increasing search costs for those trying to find evidence-based sports supplements.

Economically, the compliance burden falls disproportionately on smaller entities. Larger firms have in-house regulatory teams and can amortise labelling and reformulation costs across high volumes. A start-up producing a niche sports gel may need to spend thousands of dollars on legal review, composition testing and label redesign to ensure compliance with cross-referenced schedules. The sodium and potassium limits also constrain formulation flexibility: a product that uses certain buffering agents (e.g. sodium bicarbonate) might exceed the 70 mmol limit, forcing reformulation or a reduced dose recommendation that makes the product less competitive.

Regulators,Food Standards Australia New Zealand (FSANZ) and state enforcement agencies,manage compliance and enforcement. FSANZ issues the Standard but does not directly enforce it; enforcement is delegated to state and territory food Acts. This creates potential inconsistencies in enforcement severity across jurisdictions.

The Standard imposes several specific duties on any person who sells or distributes a formulated supplementary sports food.

First, a duty to comply with the compositional limits in section 2.9.4-3. The food must not exceed 70 mmol sodium or 95 mmol potassium per one-day quantity. It must not contain vitamins, minerals, amino acids or other nutritive substances outside the permitted lists and maximum amounts. If a manufacturer adds a substance not listed in S29-16, S29-18 or S29-19, that addition is automatically non-compliant, even if the substance is generally safe. The duty is strict; there is no safety defence.

Second, a duty to include all required statements and information on the label (section 2.9.4-4). These are: the non-sole-source statement, the exercise program statement, the warning about children and pregnant women, and the phenylalanine warning if applicable. Additionally, directions for use including recommended amount and frequency, a statement of recommended daily consumption, and a nutrition information panel are required. The label must also use “Formulated supplementary sports food” as the prescribed name (section 2.9.4-4(2)). Failure to include any of these makes the product non-compliant under the labelling provisions of Standard 1.2.1.

Third, a duty to comply with the prohibitions on claims. Section 2.9.4-7 prohibits any express or implied representation that relates any property or proposed use to enhanced athletic performance or beneficial physiological effects, unless explicitly permitted in Division 3. This is a broad duty: even a statement like “supports energy production” could be construed as implying a beneficial physiological effect. The duty is not limited to written claims; it covers implied representations through images, layout, or brand name. The practical effect is that the entire marketing of the product is constrained, not just the label.

Fourth, a duty regarding nutritive substance claims (section 2.9.4-5). If the label refers to the presence of a non-vitamin, non-mineral nutritive substance, the label must either state the amount by weight per 100 g or per percentage immediately after the claim, or list the substance and average quantity in the nutrition information panel. This duty applies only if the claim is not required by another Code provision.

Fifth, a duty not to claim the presence of a vitamin or mineral unless it meets the 10% RDI or ESADDI threshold (section 2.9.4-6(2)). A manufacturer can only claim a vitamin or mineral if a serving contains at least 10% of the RDI and the amount claimed is not above the maximum in S29-16.

The rights conferred are essentially limited: the right to use the name and market the product if compliant, and the right to make the specific claims allowed in Division 3 for products that fit the definitions. Those claims are listed in sections 2.9.4-8(2), 2.9.4-9(2) and 2.9.4-10(2). For high carbohydrate supplement: statements about being useful before/during/after exercise and assisting in carbohydrate energy provision. For protein energy supplement: statements about low-bulk diet, high energy source, assisting muscle bulk development, and usefulness before/during/after exercise. For energy supplement: statements about supplementing energy and usefulness before/during/after exercise. These are the only specific performance-related claims that are permitted; any other performance claim is prohibited.

There is also a right to add permitted vitamins, minerals, amino acids and other substances within the prescribed amounts, but that right is implicitly constrained by the prohibition on making performance claims about them unless they fit a subcategory.

The Standard itself does not set out penalties. Enforcement occurs through the Food Standards Australia New Zealand Act 1991 (Cth) and corresponding state and territory food Acts. Under the FSANZ Act, it is an offence to sell food that does not comply with a standard, but the Act does not prescribe a specific penalty for violating Standard 2.9.4. Instead, each state and territory has its own Food Act (e.g. Food Act 2003 (NSW), Food Act 1984 (Vic)) which generally make it an offence to sell food that does not comply with the Code. Penalties vary: most set maximum fines for individuals in the range of $50,000 to $100,000 and for corporations up to $500,000 or more, with potential imprisonment in serious cases involving public health risk.

The Standard’s strict liability provisions mean that a business cannot argue ignorance of the rules as a defence. If a product contains a prohibited nutritive substance or exceeds the sodium limit, the seller faces prosecution regardless of whether they knew the product was non-compliant. This places a heavy due diligence burden on importers and retailers who buy from overseas suppliers. A retailer who stocks a sports drink that turns out to have 80 mmol sodium per day will be liable, even if the supplier provided a certificate of analysis stating 65 mmol.

Enforcement actions can include product recall, seizure and destruction of non-compliant product, injunctions to stop sale, and adverse publicity orders. The Standard’s warning statement about children and pregnant women is critical: if a product does not display that warning, it is automatically non-compliant and can be removed from shelves. Regulators may also issue infringement notices (on-the-spot fines) for minor labelling breaches, though this depends on jurisdiction.

The cross-border nature of sports food sales (many products are imported) adds enforcement complexity. Imported goods must comply at the border; the Department of Agriculture, Fisheries and Forestry inspects imported food and can refer products to state food authorities. The Standard does not contain any defense for products sold online or through supplementary channels like gyms; all sales points are captured.

Litigation under this Standard is likely rare due to its prescriptive nature,most disputes would be administrative, such as a regulator issuing a non-compliance notice and the business correcting the label. However, if a business disputes a regulator’s interpretation (e.g., whether a product is a formulated supplementary sports food or a general food), it could end up in court. The prohibition on implied representations (section 2.9.4-7) could be contentious: what exactly constitutes an “implied representation” relating to athletic performance? A product named “Enduro Max” with a lightning bolt graphic might be found to imply performance benefits, even if no words say so. Such interpretive disputes could lead to litigation, but no cases are recorded in the source.

Standard 2.9.4 is part of the Australia New Zealand Food Standards Code, which is a legislative instrument under the Food Standards Australia New Zealand Act 1991. It does not operate in isolation; it cross-references several other standards and schedules. Section 2.9.4-3(1)(a) references S29-16, S17-2, S17-3 and S29-17 for permitted vitamins and minerals. Section 2.9.4-3(1)(b) references S29-18 for amino acids, and section 2.9.4-3(1)(c) references S29-19 for other nutritive substances. The labelling provisions in section 2.9.4-4 reference Standard 1.2.1 (labelling and other information requirements). The nutrition information panel required must comply with Standard 1.2.8 (nutrition information requirements), not elaborated here but implied. The warning statement format and location are governed by Standard 1.2.1. Average energy content calculation uses the equation in S11-2.

The Standard interacts with general food law in that any product that is not a “formulated supplementary sports food” might be subject to other standards (e.g., Standard 2.9.1 for infant formula, Standard 2.9.3 for meal replacements, or general standards for conventional foods). A product that claims to assist sports performance but is not specifically formulated for sports people might be regulated under general food standards and the misleading conduct provisions of state fair trading Acts. The line between a formulated supplementary sports food and a general food is not always clear,a protein bar sold in a supermarket may be a general food if it is not marketed to sports people, but if the same bar is sold in a gym with “for athletes” on the label, it may fall under this Standard.

Therapeutic goods regulation also interacts. If a sports food makes a therapeutic claim (e.g., “treats muscle soreness”), it may be regulated as a therapeutic good under the Therapeutic Goods Act 1989 (Cth) and require listing or registration. The Standard’s prohibition on performance claims does not prevent a product from being regulated as a therapeutic good if it makes such claims; the two regulatory systems overlap. A product that is a therapeutic good might also be a food, but the Therapeutic Goods Administration (TGA) would have primary jurisdiction. The Standard does not address this interface, so dual compliance may be required.

Competition and consumer law under the Competition and Consumer Act 2010 (Cth) also applies. Even if a product complies with the Standard, it could still be misleading under the Australian Consumer Law if, for example, the recommended use is not supported by evidence. The Standard’s permission for certain claims (e.g., “may assist in the development of muscle bulk”) does not exempt the manufacturer from the prohibition on false or misleading representations; the manufacturer must have reasonable grounds for the claim.

In New Zealand, the Standard is adopted under the Food Act 2014 (NZ). New Zealand-specific legislation may also apply, such as the Fair Trading Act 1986, for misleading conduct. The trans-Tasman mutual recognition scheme for food standards means a product that complies with the Code in Australia is generally accepted in New Zealand, but enforcement and interpretation may differ.

Standard 2.9.4 was first published in the Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 (F2015L00421 - 31 March 2015). The commencement date was 1 March 2016. Since then, three amendments have been recorded in the Amendment History up to the compilation date of 13 April 2017 (compilation No. 2).

Amendment No. 157 (F2015L01374, 1 September 2015, Gazette FSC99 3 September 2015) corrected a typographical error in section 2.9.4-5(2)(a) and in section 2.9.4-6(2)(a). Both corrections related to paragraph (a) of those subsections; the exact nature of the typos is not described, but they were likely punctuation or cross-reference errors. These amendments commenced on 1 March 2016, the same day as the Standard itself.

Amendment No. 161 (F2016L00120, 18 February 2016, Gazette FSC103 22 February 2016) again corrected a typographical error in section 2.9.4-6(2)(a). This suggests that the earlier correction in Amendment 157 was incomplete or introduced a new error. The amendment also commenced 1 March 2016.

Amendment No. 168 (F2017L00414, 11 April 2017, Gazette FSC110 13 April 2017) repealed and substituted subsection 2.9.4-6(2) to clarify the provision and correct a grammatical error. This was a substantive relabelling of the requirements for vitamin and mineral claims. The amendment commenced on 13 April 2017.

The amendment history shows that the Standard has been subject to minor corrections rather than major policy shifts. The two corrections to the same subsection indicate that the original drafting was not error-free, and the subsequent substitution in 2017 suggests that the earlier attempts at correction were insufficient. This is a compliance risk: if FSANZ itself was unsure about the precise wording for two years, manufacturers who relied on the original wording might have inadvertently used non-compliant labels during that period. However, because the corrections were backdated to commencement, a manufacturer who used the pre-correction wording could argue that the error was not their fault, but enforcement authorities are unlikely to accept that defence given strict liability.

No other amendments are recorded as affecting the Standard up to compilation No. 2. The note mentions uncommenced amendments or provisions ceasing to have effect, but none are identified in the visible text. This suggests the Standard has remained stable since 2017, but users should check the Federal Register of Legislation for any post-2017 amendments.

The source does not mention any litigation concerning Standard 2.9.4. The compiled Standard is an instrument, not a judgment, and FSANZ compilations do not include case summaries. Therefore, no specific cases are recorded. This absence is not surprising: food standards litigation is infrequent because most disputes are resolved administratively through compliance notices, recalls, or negotiations with regulators.

However, a few potential areas of litigation can be inferred from the text. First, the definition of “formulated supplementary sports food” could be challenged. If a product is borderline,e.g., a powdered drink mix that contains vitamins and claims to “support energy”,a regulator might argue it falls under the Standard, while the manufacturer might argue it is a general food. The case would turn on whether the product was “specifically formulated to assist sports people”. Courts would likely look at the product’s labelling, marketing and intended use. A manufacturer who avoided the Standard’s restrictions by claiming the product is not for sports people could be sued for misleading conduct or prosecuted for selling a non-compliant sports food if the regulator disagrees.

Second, the prohibition on implied representations (section 2.9.4-7) is open to interpretation. A product called “Go Faster” with a cheetah picture could be seen as implying enhanced athletic performance. A manufacturer could argue the name and image are fanciful and not intended to make a performance claim. A court would need to decide the test for “implied representation”: would a reasonable consumer understand the representation to relate to performance? This is a factual question, and different tribunals could reach different conclusions.

Third, the warning statement requirement for phenylalanine (section 2.9.4-4(1)(a)(iv)) could lead to disputes if a product contains phenylalanine from protein (which all protein powders do) versus added phenylalanine. The Standard says “if the food contains added phenylalanine”. The term “added” is ambiguous,does it cover phenylalanine added as a free amino acid, or does it also cover phenylalanine naturally occurring in protein ingredients that are added? A strict reading suggests only the former, but regulators might argue that any phenylalanine resulting from added ingredients qualifies.

Fourth, the sodium and potassium limits (section 2.9.4-3(2)) are absolute. A manufacturer who sets a very low one-day quantity (e.g., 5 g) could legally include a high concentration of sodium in a product because the absolute amount per day would be low. A regulator might challenge that if the directions are unrealistic for actual use. Litigation could arise over whether the one-day quantity must be reasonably practical, not just whatever the manufacturer chooses. The Standard does not address this, so a court would need to apply purposive interpretation.

Despite these potential issues, no known cases have been litigated to judgment under this Standard. The compliance industry for sports foods in Australia is relatively small, and businesses tend to avoid court due to cost and reputational risk. Most disputes are resolved through informal correspondence with state food authorities. Any litigation would likely be brought by a regulator seeking an injunction, not by a private competitor, because the Standard does not create a private right of action.

Several traps await manufacturers and importers who do not read the Standard closely.

The “performance representation” trap. Section 2.9.4-7 prohibits any express or implied representation that relates any property or proposed use of the food to enhanced athletic performance or beneficial physiological effects. This is extraordinarily broad. A statement such as “increases stamina” is obviously captured. But so might “supports recovery”, “boosts energy”, “optimises metabolism”, or even “for active individuals”. The trap is that many sports foods are marketed with such phrases, and if the product does not fit one of the Division 3 subcategories, those phrases are prohibited. Even if the product fits a subcategory, only the specific claims listed in sections 2.9.4-8(2), 2.9.4-9(2) or 2.9.4-10(2) are allowed,nothing else. A protein energy supplement cannot say “builds muscle” because the permitted claim is “may assist in the development of muscle bulk”. The difference is subtle but legally significant.

The “one-day quantity” manipulation risk. Manufacturers might be tempted to set a very small recommended daily intake to stay under the sodium and potassium limits. However, if the directions are not reasonable for actual use (e.g., recommending 1 g of powder per day for a product that is typically consumed in 30 g servings), a regulator could argue that the one-day quantity is not genuine and that the product is non-compliant. The Standard does not define “reasonable” directions, but the overall context of consumer protection gives regulators leeway to challenge unrealistic recommendations.

Cross-reference maze. Section 2.9.4-3(1) says a vitamin or mineral may be added only if listed in S29-16 and in permitted forms from S17-2, S17-3 or S29-17. S29-16 is not reproduced in the Standard; it is in another part of the Code. A manufacturer who relies on a general list of permitted vitamins from memory may miss that certain forms are not allowed, e.g., vitamin K as menaquinone may be permitted but not phylloquinone, or vice versa. The same applies to amino acids (S29-18) and other substances (S29-19). The Standard punishes ignorance: adding a substance not on the list is an immediate violation.

New Zealand differences. Although the Standard is joint, New Zealand may have different enforcement interpretations and different penalties under the Food Act 2014 (NZ). A product compliant in Australia might still attract attention from New Zealand authorities if, for example, a warning statement is in a different location than New Zealand expects. The Standard does not harmonise enforcement.

Phenylalanine warning is easy to miss. Section 2.9.4-4(1)(a)(iv) requires the warning “Phenylketonurics: Contains phenylalanine” only if the food contains added phenylalanine. Many protein supplements add amino acids including phenylalanine as a free form. But even if no free phenylalanine is added, the product’s protein content will contain phenylalanine. The question is whether “added phenylalanine” includes phenylalanine that is naturally present in added protein ingredients. A cautious manufacturer should test the product to see if the total phenylalanine content warrants the warning, but the Standard only requires it for “added” phenylalanine. This ambiguity could be exploited, but it could also be a compliance risk if a regulator takes a broad view.

Claims on vitamins and minerals. Section 2.9.4-6(2) says a label may claim the presence of a vitamin or mineral only if a serving contains at least 10% RDI. This threshold is higher than the general food provision for “source of” claims (typically 10% is standard, but sports foods must also not claim more than the amount in S29-16 column 3). So a product with a vitamin E content above the permitted maximum cannot make a claim for that vitamin even if it is below the maximum. The trap is checking both limits: the 10% floor and the maximum ceiling.

Failure to update labels after amendments. The 2017 amendment to section 2.9.4-6(2) replaced the entire subsection. Any manufacturer using the pre-13 April 2017 wording would be non-compliant from that date. If a label was printed before the amendment and there is no stock inventory management, old labels could be used after the commencement, leading to a violation.

Compliance with Standard 2.9.4 requires a systematic approach covering formulation, labelling and documentation.

First, determine whether a product falls within the definition of “formulated supplementary sports food”. If the product is marketed to sports people for nutritional or performance goals,especially if sold in gyms, sports stores, or with sports imagery,the Standard almost certainly applies. If the product is a general food such as muesli bar marketed as “energy for active people”, but not specifically formulated for sports people, it might not trigger the Standard. However, to be safe, assume the Standard applies if any part of the label or marketing targets athletic performance. If in doubt, treat it as a formulated supplementary sports food to avoid the risk of prosecution for selling a non-compliant product.

Second, design the formulation to comply with section 2.9.4-3. Calculate the one-day quantity based on the recommended daily consumption. Ensure that a one-day quantity contains no more than 70 mmol sodium (approx. 1.6 g sodium) and 95 mmol potassium (approx. 3.7 g potassium). Check that any added vitamins, minerals, amino acids or other nutritive substances are listed in the relevant schedules (S29-16, S29-18, S29-19) and are added in a permitted form (S17-2, S17-3 or S29-17). Use only the amounts specified in Column 2 of those tables. For substances not listed, do not add them.

Third, decide whether the product fits one of the three subcategories in Division 3: high carbohydrate supplement, protein energy supplement, or energy supplement. The definitions depend on the percentage of average energy content from carbohydrate, protein and fat. Use the equation in S11-2 to calculate average energy content. If the product fits, you gain access to the specific permitted claims. If it does not fit, you cannot make any performance-related claim (section 2.9.4-7). Consider reformulating to fit a subcategory if claims are essential to marketing.

Fourth, prepare the label. The label must include:

• The prescribed name “Formulated supplementary sports food” (section 2.9.4-4(2)).
• The three compulsory statements under section 2.9.4-4(1)(a): non-sole source statement, exercise program statement, and the warning about children/pregnant women/medical supervision.
• If phenylalanine is added, the phenylketonurics warning.
• Directions for use including recommended amount and frequency (section 2.9.4-4(1)(b)(i)).
• Statement of the recommended consumption in one day (section 2.9.4-4(1)(b)(ii)).
• Nutrition information panel (section 2.9.4-4(1)(b)(iii)), which must comply with Standard 1.2.8.
• If the product is a high carbohydrate supplement, add the statements about gastro-intestinal upset and fluid intake (section 2.9.4-8(1)).
• If it is a protein energy supplement, add the fluid intake statement (section 2.9.4-9(1)).
• If it is an energy supplement, add the gastro-intestinal upset statement, fluid intake statement, and if high fat, the special fat loading statement (section 2.9.4-10(1)).
• For any nutritive substance claim (non-vitamin/non-mineral), state the amount immediately after the claim or in the nutrition panel (section 2.9.4-5).
• For any vitamin or mineral claim, ensure a serving contains at least 10% RDI/ESADDI and that the claimed amount does not exceed the maximum in S29-16 column 3 (section 2.9.4-6).

Fifth, review all label claims for compliance with the prohibition in section 2.9.4-7. Remove any express or implied representation that relates to enhanced athletic performance or beneficial physiological effects, unless it is one of the specific permitted claims from Division 3. Even statements like “for optimal performance” could be problematic. If the product fits a subcategory, you may use only the exact wording permitted. For a protein energy supplement, the claim “may assist in the development of muscle bulk” is allowed; “builds muscle” is not.

Sixth, ensure the nutrition information panel and any volumetric claims (e.g., “15 g protein”) are accurate and supported by validated analysis. The Standard does not mandate a specific testing method, but the values must be representative of the product. Retain certificates of analysis and records of calculation for average energy content.

Seventh, if importing products, obtain a certificate of analysis from the overseas manufacturer for sodium, potassium, and any added nutritive substances. Verify that the label as imported complies with all requirements. Be aware that importers are strictly liable for non-compliance even if the foreign manufacturer assured compliance.

Finally, monitor the Federal Register of Legislation and the FSANZ website for amendments to Standard 2.9.4 or the cross-referenced Schedules. Any amendment may require reformulation or relabeling. Establish a review process at least annually to check for changes. If a label is printed in large quantities, include a provision in purchase orders that labels must be updated within a specific time of any regulatory change.

Document all compliance decisions in a written file, including formulation calculations, schedule checks, label drafts with justifications for each required statement and each claim. This file is crucial if a regulator investigates and can demonstrate due diligence, although the Standard is strict liability, a well-documented compliance program may mitigate penalties in some jurisdictions.