{"id":8931,"date":"2025-06-17T08:01:40","date_gmt":"2025-06-17T12:01:40","guid":{"rendered":"https:\/\/diaztradelaw.com\/?p=8931"},"modified":"2025-06-17T08:01:40","modified_gmt":"2025-06-17T12:01:40","slug":"five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us","status":"publish","type":"post","link":"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/","title":{"rendered":"Five Tips for SMEs Looking to Scale Wellness Brands in the US"},"content":{"rendered":"

DTL President Jennifer Diaz was featured in Santander Navigator! Read below or on Santander <\/span><\/i>here<\/span><\/i><\/a>.<\/span><\/i><\/p>\n

Pre-planning and investing in regulatory compliance measures are key to success<\/span><\/em><\/p>\n

The US is the most lucrative wellness market in the world \u2013 and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore.\u00a0<\/span><\/p>\n

And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to <\/span>research by the Global Wellness Institute<\/span><\/a>.\u00a0<\/span><\/p>\n

In contrast, China\u2019s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn.<\/span><\/p>\n

However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance.<\/span><\/p>\n

Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA\u2019s blacklist.<\/span><\/b><\/p>\n

1. Know the regulators<\/b><\/h3>\n

One of the first steps for SMEs planning to import supplements into the US is to <\/span>register with the FDA<\/span><\/a>, as they are considered a food product, Diaz says.<\/span><\/p>\n

Companies also need to <\/span>designate a US agent<\/span><\/a> to act on their behalf before shipments begin.<\/span><\/p>\n

\u201cMost entities also don\u2019t realize that the US has 47 regulatory agencies that can regulate imports and exports, so you may be dealing with multiple federal regulatory agencies that regulate your product,\u201d<\/em> she adds.<\/span><\/p>\n

For example, the FDA, Federal Trade Commission (FTC) and US Customs regulate the imported supplements market, she says.<\/span><\/b><\/p>\n

2. Beware of being blacklisted<\/b><\/h3>\n

One underestimated risk for SMEs launching their supplements in the US is the FDA\u2019s <\/span>import alert system<\/span><\/a>, which Diaz describes as a blacklist for companies that have failed to comply with regulations.<\/span><\/p>\n

This could be anything from mislabeling products to not using English on labels, making false medical claims, or failing to register with the FDA, Diaz explains, adding that it is time-consuming and costly to be removed from the list.<\/span><\/p>\n

\u201cMany SMEs don\u2019t have the ability to survive the enforcement because the full weight of the government on you when you\u2019re non-compliant is big,\u201d<\/em> she says.<\/span><\/p>\n

\u201cThe government does not have the resources to hold your hand and help you when it comes to compliance \u2013 the expectation is that the product is already compliant and you\u2019re smart enough to pick the right business partners and agents before you launch.\u201d<\/span><\/em><\/b><\/p>\n

3. Be wary of influencers<\/b><\/h3>\n

Marketing claims, even those from third parties such as influencers, also fall under FDA and FTC regulations, according to Diaz.<\/span><\/p>\n

\u201cWhat many don\u2019t realize is that the FDA can legally make your life miserable over your marketing claims, in addition to what\u2019s on your product,\u201d<\/em> Diaz says.<\/span><\/p>\n

For example, suppose a business sends a supplement to an influencer to promote it on social media and they claim that it cured their cancer. In this case, the company is deemed liable if they don\u2019t \u201cde-escalate\u201d the claim, Diaz explains.<\/span><\/p>\n

\u201cThe FDA has the legal ability to issue a company a warning letter for the claims that they make on their website or for the claims that influencers make on their behalf on social media.\u201d<\/span><\/em><\/b><\/p>\n

4. Set a budget for compliance<\/b><\/h3>\n

Not spending the time or money on <\/span>pre-compliance preparation<\/span><\/a> can also lead to costly errors, says Diaz.<\/span><\/p>\n

\u201cIt could be hundreds of thousands of dollars if your goods are seized or you receive an FDA audit or warning letter,\u201d<\/em> she says.<\/span><\/p>\n

Diaz recommends that SMEs conduct independent testing in a laboratory to verify ingredient claims, as well as taking out product liability insurance to protect against litigation and organizing a legal review of all labels, ingredients and marketing content.<\/span><\/b><\/p>\n

5. Protect your brand<\/b><\/h3>\n

Diaz also recommends that SMEs protect their brands by registering them with the US Patent and Trademark Office.<\/span><\/p>\n

\u201cOnce you register your trademark, you should also <\/span>record it with US Customs<\/span><\/a><\/em> and then teach them how to spot copies of your brand, such as unique packaging,\u201d<\/em> Diaz says.\u00a0<\/span><\/p>\n

\u201cCustoms then logs it in its secret database and it goes to all customs officers \u2013 there are 60,000 customs officers in the country at 328 ports of entry \u2013 and they will fine the offender and alert you if they spot a fake.\u201d<\/span><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

DTL President Jennifer Diaz was featured in Santander Navigator! Read below or on Santander here. Pre-planning and investing in regulatory compliance measures are key to success The US is the most lucrative wellness market in the world \u2013 and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore.\u00a0 And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute.\u00a0 In contrast, China\u2019s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn. However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance. Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA\u2019s blacklist. 1. Know the regulators One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says. Companies also need to designate a US agent to act on their behalf before shipments begin. \u201cMost entities also don\u2019t realize that the US has 47 regulatory agencies that can regulate imports […]<\/p>\n","protected":false},"author":3,"featured_media":8932,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[9,28,59,61,99,89],"tags":[164,123,180,167],"class_list":["post-8931","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-best-practices","category-import-alert","category-international-business","category-international-trade","category-labeling","category-compliance","tag-compliance","tag-import","tag-labeling","tag-trademark"],"yoast_head":"\nFive Tips for SMEs Looking to Scale Wellness Brands in the US - Customs & International Trade Law Firm<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Five Tips for SMEs Looking to Scale Wellness Brands in the US - Customs & International Trade Law Firm\" \/>\n<meta property=\"og:description\" content=\"DTL President Jennifer Diaz was featured in Santander Navigator! Read below or on Santander here. Pre-planning and investing in regulatory compliance measures are key to success The US is the most lucrative wellness market in the world \u2013 and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore.\u00a0 And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute.\u00a0 In contrast, China\u2019s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn. However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance. Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA\u2019s blacklist. 1. Know the regulators One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says. Companies also need to designate a US agent to act on their behalf before shipments begin. \u201cMost entities also don\u2019t realize that the US has 47 regulatory agencies that can regulate imports […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/\" \/>\n<meta property=\"og:site_name\" content=\"Customs & International Trade Law Firm\" \/>\n<meta property=\"article:publisher\" content=\"http:\/\/facebook.com\/diaztradelaw\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-17T12:01:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/diaztradelaw.com\/wp-content\/uploads\/2025\/06\/DTL-Q1-2025-2025-06-16T090354.980.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1067\" \/>\n\t<meta property=\"og:image:height\" content=\"612\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Jennifer Diaz\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@diaztradelaw\" \/>\n<meta name=\"twitter:site\" content=\"@diaztradelaw\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jennifer Diaz\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/\"},\"author\":{\"name\":\"Jennifer Diaz\",\"@id\":\"https:\/\/diaztradelaw.com\/#\/schema\/person\/e4358517dcb10b6d836c8962295b4d96\"},\"headline\":\"Five Tips for SMEs Looking to Scale Wellness Brands in the US\",\"datePublished\":\"2025-06-17T12:01:40+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/\"},\"wordCount\":750,\"commentCount\":0,\"image\":{\"@id\":\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/i0.wp.com\/diaztradelaw.com\/wp-content\/uploads\/2025\/06\/DTL-Q1-2025-2025-06-16T090354.980.png?fit=1067%2C612&ssl=1\",\"keywords\":[\"compliance\",\"Import\",\"Labeling\",\"trademark\"],\"articleSection\":[\"Best Practices\",\"Import Alert\",\"International Business\",\"International Trade\",\"Labeling\",\"Pre-compliance\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/\",\"url\":\"https:\/\/diaztradelaw.com\/five-tips-for-smes-looking-to-scale-wellness-brands-in-the-us\/\",\"name\":\"Five Tips for SMEs Looking to Scale Wellness Brands in the US - 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However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance. Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA\u2019s blacklist. 1. Know the regulators One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says. 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